Versa Nail Femoral Universal System Surgical Technique
2016-04-01
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VersaNail ® Femoral Universal Product Rationale and Surgical Technique TRAUMA VersaNail ® Femoral Universal Contents Design Summary.........................................................................................................................................................3 Implant Overview.........................................................................................................................................................4 Antegrade Entry and Canal Preparation.......................................................................................................................6 Antegrade Nail Insertion.............................................................................................................................................10 Antegrade Locking....................................................................................................................................................13 Retrograde Entry and Canal Preparation....................................................................................................................20 Retrograde Nail Insertion...........................................................................................................................................24 Retrograde Locking...................................................................................................................................................29 End Cap Placement and Nail Removal......................................................................................................................35 Ordering Information..................................................................................................................................................38 Flexible Reaming System...........................................................................................................................................42 Note: This brochure presents a surgical technique available for use with the Biomet VersaNail® Platform instruments and implants. Surgeons may need to make modifications as appropriate in their own surgical technique with these devices depending on individual patient requirements. 1 VersaNail ® Femoral Universal One Implant Designed for the Efficient Treatment of a Range of Femur Fractures • Anatomically designed for treatment of both antegrade and retrograde applications • The intuitive, universal instrumentation system enables efficiency in the OR • Universal design to aid inventory management The VersaNail® Femoral Universal Nail is part of a long bone nailing system that offers a complete portfolio of implants and instruments based on a single, standardized technology platform. The Femoral Universal Nail System from the VersaNail Platform offers options to treat a range of femoral fractures using either an antegrade or retrograde approach with one implant. The VersaNail Platform instrumentation system is designed for intuitive assembly and ease-of-use by OR staff and surgeons, enabling a simpler and more efficient procedure. The instrumentation is designed to provide intra-operative options including entry portals, reduction tools and color-coded screw placement, while being standardized to maintain commonality across the platform. 3 VersaNail ® Femoral Universal The Femoral Universal Nail is designed to treat: • Femoral shaft fractures • Proximal or mid-shaft femoral non-unions and malunions • Pathologic fractures in osteoporotic bone of the diaphyseal area • Revision procedures Universal design allows one nail for either antegrade or retrograde application to treat right- or left-sided fractures. Enlarged nail cannulation accepts the ball nose guide wire, eliminating the need for an exchange tube. 2.2 meter radius of curvature accommodates the anterior bow of the femur. Large core diameter of 4.5 mm non-drive end screws decreases the risk of screw breakage. Distal locking options to treat a greater range of fracture patterns. Bullet-style tip increases ease of insertion. 5 mm Dynamization option allows compression at the fracture site. The VersaNail Platform instrumentation system is designed to be intuitive, enabling a simpler and more efficient procedure. The VersaNail Platform’s modular nature facilitates the use of common instruments across all VersaNail nailing systems, reducing confusion among the OR staff. For example, VersaNail Platform jigs look and function the same way, and common instruments (such as awls, entry portals, guide wires, nail length gauge, locking instrumentation and screw caddies) can be used across all VersaNail Platform nailing systems. 4 12 mm Drive End Diameter for 9-12 mm Nails 0 mm Drive End Diameter Equal to Nail Diameter for 13-15 mm Nails 14 mm 64 mm 29 mm 10 mm Dymanization Range 39 mm 54 mm 12 mm drive end accommodates 6.5 mm screws. Large core diameter of 6.5 mm screws decreases risk for screw breakage. 10 mm Dynamization option allows compression at the fracture site. 48 mm 38 mm 28 mm 18 mm 5 mm Dymanization Range 13 mm 0 mm Multiple locking options for optimum implant stability The Femoral Universal Nail hole configurations provide a number of locking possibilities. The Femoral Universal Nail is locked with 6.5 mm screws on the drive end and 4.5 mm screws on the non-drive end. The locking instrumentation is color-coded for ease of use: Color Screw Size Drill Bit Size Black 6.5 mm Cortical 5.3 mm Gold 6.5 mm Cancellous 6.5 mm/4.8 mm Step Drill Silver 3.2 mm Guide Pin Sleeve Green 4.5 mm Cortical 3.8 mm 5 VersaNail ® Femoral Universal Antegrade Entry and Canal Preparation Figure 1 Figure 2 Patient Positioning Entry Site and Surgical Approach Place the patient in the supine position on a fracture or radiolucent imaging table (Figure 1). Lateral access to the proximal femur is required. The affected leg must be adducted and the trunk secured and bent toward the opposite side. The contralateral leg may be flexed at the hip or scissored below the affected leg. Identify the entry site, which is in the piriformis fossa. The ideal entry point is adjacent to the greater trochanter at the lateral edge of the piriformis fossa. 6 Initiate the entry site with a 3.2 mm guide pin through a stab incision proximal to the trochanteric region, in line with the femoral axis. Confirm correct entry location and guide pin placement radio-graphically with A/P and lateral views (Figure 2). The guide pin placement should be in line with the center of the femoral canal in both views. Figure 3 Figure 4 Once the ideal entry point has been achieved, an appropriate incision can be made. Extend the entry incision 1-2 cm (Figure 3). The Entry Portal Sheath (2810-13-005) and Trocar (281013-004) can be advanced over the guide pin down to the piriformis fossa. Parallel guide holes allow for accurate adjustment of pin positioning. Remove the trocar from the entry portal, keeping the guide pin in place.The entry portal sheath may be left in place to protect soft tissues during canal entry and reaming (Figure 4). 7 VersaNail ® Femoral Universal Antegrade Entry and Canal Preparation Figure 5 Figure 6 Figure 7 Entry Site and Surgical Approach (cont.) Canal access can be obtained using either a Cannulated Entry Reamer or Cannulated Awl (2810-01-005). Both 12 mm (2810-13-001) and 13 mm (2810-13-002) entry reamers are available depending on surgeon preference. The proximal nail diameter is 12 mm for all nail sizes equal to or less than 12 mm, and 13 mm to 15 mm nails have a proximal diameter equal to the nail diameter. Use A/P and lateral fluoroscopic views to confirm accurate placement (Figures 5 and 6). Use the awl or entry reamer to open the proximal femur in the piriformis fossa. Note: If utilizing the cannulated entry reamer, the length of the distal portion of the reamer is enlarged and matches the length of the drive end portion of the nail. Fluoroscopically verify the entry reamer has been inserted to the proper depth that will correspond with the depth of the nail. 8 Once access to the femoral canal has been gained, place the ball nose guide wire into the entry site utilizing the pistol-style Guide Wire Gripper (2810-01-001) (Figure 7). If preferred, a T-handle Guide Wire Gripper (2810-01-002) is also available as an option. Figure 8 Figure 9 Fracture Reduction Canal Preparation Once access to the femoral canal has been gained, obtain appropriate anatomic reduction in order to restore length, alignment and rotation of the injured limb. Reduction can be achieved through the surgeon’s preferred method such as traction and/or an external fixator. To aid in manipulating the fracture fragments and passing the Ball Nose Guide wire, large (7.5 mm diameter, 2810-01-007) and small (6.5 mm diameter, 2810-01-008) reduction tools are available (Figure 8). Achieve proper alignment of the fracture prior to reaming and maintain it throughout the reaming process to avoid eccentric reaming. Initiate reaming by placing the VersaNail Flexible Reamers over the 3.0 mm ball nose guide wire (Figure 9). Ream the medullary canal in millimeter increments until cortical bone is reached and half-millimeter increments thereafter. Surgeon preference should dictate the actual extent of intramedullary reaming. Monitor the reaming procedure using image intensification to avoid eccentric or excessive cortical reaming. Insert the reduction tool into the medullary canal, past the fracture site. Once the fracture is aligned, pass the Ball Nose Guide Wire, available in both 80 cm (2810-01-080) and 100 cm (2810-01-100) lengths, across the fracture site. Remove the reduction tool. 9 VersaNail ® Femoral Universal Antegrade Nail Insertion Figure 10 Figure 11 Nail Size Selection Nail Length Selection An X-ray template (2810-13-025) including 10 percent magnification is available to determine nail size preoperatively (Figure 10). With the tip of the ball nose guide wire at the level of the desired depth of nail insertion, slide or snap the Nail Length Gauge (2810-01-031) onto the ball nose guide wire until the nose contacts the bone, ensuring the tip does not fall into the existing entry canal, which could result in an inaccurate measurement (Figure 11). Nail Diameter Selection Generally, a nail diameter 1 mm to 1.5 mm less than the final reamer diameter is chosen. Femoral Universal Nails are available in 1 mm increments from 9 mm to 15 mm diameters. 10 Figure 12 Figure 13 Nail/Jig Assembly To obtain the appropriate nail length, read the measurement mark on the nail length gauge that is closest to the beginning of the black transition area on the guide wire (Figure 12). If a nail of the exact measured length is not available, choose a shorter nail of the next closest available length. A direct measurement can also be taken of the uninjured extremity using either radiographs with magnification markers, or directly on the uninjured limb. Place the nail on the femoral insertion handle in the correct orientation. The nail should be oriented on the femoral insertion handle such that the anterior bow of the nail is in line with the anterior bow of the femur and the jig is lateral to the nail. Secure the nail to the femoral insertion handle by inserting the Femoral Jig Bolt (2810-13-008) through the cannulation of the nose and tightening with the Jig Bolt Driver (2810-13-006) and T-handle (2810-01-004) (Figure 13). 11 VersaNail ® Femoral Universal Antegrade Nail Insertion 15 mm 5 mm Nail/Jig Junction Figure 14 Figure 15 Figure 16 Nail Insertion Once proper reduction has been achieved, insert the nail over the 3 mm ball nose guide wire into the medullary canal (Figure 14). It is important not to strike the femoral insertion handle directly. Attach the Hammer Pad (2810-13-011) to the insertion handle (Figure 15). Ensure that the hammer pad is tightened thoroughly prior to impaction. Avoid excessive force when inserting the nail. If the nail jams in the medullary canal, extract it and choose the next-smaller diameter nail or enlarge the canal appropriately. 12 Note: The femoral insertion handle is marked with three grooves (Figure 16). The groove closest to the nail is an indicator for the nail/insertion handle junction. A K-wire can be inserted lateral to medial through the target arm if additional identification of the nail/ insertion handle junction is needed. The middle groove is marked 5 mm from the top of the nail and the groove farthest from the nail is marked 15 mm from the top of the nail. Ensure the nail is seated to proper depth for planned dynamization. Confirm fracture reduction and ensure appropriate nail insertion depth proximally and distally with biplanar fluoroscopy. Remove the ball nose guide wire. Antegrade Locking Figure 17 Dynamization Universal Target Arm Assembly A dynamic slot has been incorporated in the drive end and non-drive end of the nail. The drive end slot has a 10 mm range of dynamization. The non-drive end slot has a 5 mm range of dynamization. If dynamization is planned, countersink the nail to the appropriate depth to avoid backing out of the nail into the proximal soft tissues. Lock the M/L slot in the dynamic mode. Delayed dynamization may be performed at a later date with the removal of the static screws. Attach the radiolucent Universal Target Arm (2810-13-009) onto the insertion handle, using the Target Arm Attachment Bolt (2810-13-026) and hand tighten (Figure 17). Ensure the target arm is properly secured to the insertion handle for excellent targeting. Locking Prior to locking both proximally and distally, check femoral length and rotational alignment. The nail can be locked either distally or proximally first, depending on surgeon preference. 13 VersaNail ® Femoral Universal Antegrade Locking K-wire (indicator for nail/jig junction) Static Locking Hole Slot - Dynamic Mode Slot - Static Mode Static Locking Mode Figure 18 Figure 19 Figure 20 Proximal Locking The universal target arm is marked to identify which locking option is being targeted (Figure 18). Place 6.5 mm cortical locking screws using the black instrumentation (Figure 19). 14 Place the 6.5 mm Screw Sheath (2810-13-020) and Trocar (2810-13-021) through the appropriate holes in the jig’s targeting arm to locate the incision site (Figure 20). Make a stab incision and advance the sheath and trocar to the bone. Soft tissue dissection should be completed sharp and precise to clear a path for the sheath. Undue soft tissue tension against the sheath can cause misdirect drilling. Figure 21 Figure 22 Note: A 3.2 mm x 17.5 in Guide Pin (9030-03-004) and 3.2 mm Pin Guide Sleeve (2810-13-018) can be used to verify screw position prior to drilling (Figure 21). Figure 23 Utilizing the 5.3 mm Drill Bit (2810-13-153) drill through the drill sleeve and sheath until the far cortex is penetrated (Figure 23). Remove the trocar and replace it with the 5.3 mm Drill Sleeve (2810-13-022) (Figure 22). 15 VersaNail ® Femoral Universal Antegrade Locking Figure 24 Figure 25 Proximal Locking (cont.) Read the calibration on the drill bit that lines up with the drill sleeve to determine the screw length (Figure 24). Ensure the drill sleeve is on bone and read the calibration on the drill bit at the end of the drill sleeve to determine the appropriate screw length (Figure 24). If penetrating the far cortex prior to taking the reading, use the screw length indicated on the drill bit at the screw depth measurement line. If you are not penetrating the far cortex prior to taking the reading, add 5 mm in length to the screw length reading. 16 If further screw length is required, or if the locking hole has been initiated with a guide pin, a 6.5 mm Screw Depth Gauge (2810-13-035) is available to read screw length off of the 3.2 mm x 17.5 in guide pin (Figure 25). Figure 26 Figure 27 Distal Locking Verify fluoroscopically to assure the proper screw length selection. Remove the drill sleeve. Using the 6.5 mm Screwdriver Shaft (2810-13-024), insert the 6.5 mm cortical screw through the sheath. The etch mark on the screwdriver corresponds with the screw sheath to indicate when the screw is fully seated (Figure 26). Place 4.5 mm cortical locking screws using the green instrumentation (Figure 27). Use caution as the most proximal screw position could be in femoral neck, depending on the depth of the nail. Repeat above steps for additional screw placement. 17 VersaNail ® Femoral Universal Antegrade Locking Figure 28 Figure 29 Distal Locking (cont.) Use fluoroscopy to conduct freehand locking utilizing a familiar freehand technique. A Black Radiolucent Wand (2810-12-016) is available to aid in freehand locking (Figure 28). 18 Accurate C-arm position is confirmed when the distal nail hole appears to be a perfect circle. Once correct placement has been verified fluoroscopically, make a stab wound in direct alignment with the distal hole (Figure 29). A compensation factor is built into the measurement of the screw depth gauge (for the screw head and cutting flutes), and the calibrated drills (for the screw head only). If penetrating the far cortex prior to taking the reading, use the screw length indicated on the drill bit at the screw depth measurement line. If you are not penetrating the far cortex prior to taking the reading, add 5 mm in length to the screw length reading. Figure 30 Figure 31 Determining Screw Length Using the 3.8 mm Drill Bit (6 in: 2810-12-138 or 8 in: 2810-13-138), drill until the second cortex is reached or penetrated. Verify the drill bit position fluoroscopically prior to taking any measurements. Place the green 4.5 mm Screw Length Gauge (2810-01-032) onto the calibrated drill bit and advance down to the bone. Read the calibration on the drill bit that corresponds to the measurement line indicated on the screw length gauge (Figure 30). A Screw Depth Gauge (2810-01-017) is also provided for further screw length verification. For an accurate reading, take care to ensure the 4.5 mm screw length gauge or screw depth gauge sheath is fully seated on the bone. Remove the drill bit and advance the 4.5 mm screw. Repeat above steps for additional screw placement. The SolidLok® Screwdriver (2810-01-020 and 2810-01-021) can be utilized to capture the screw while passing it through soft tissue during screw placement. The screw size indicates the total measurement from the tip to the screw head. The calibrated drills and the screw depth gauges have a compensation factor built into the measurement such that the reading should indicate the exact size screw to achieve bi-cortical purchase. To ensure a proper reading, the screw depth gauge and drill sleeves must be touching bone. Fluoroscopy is recommended to verify the correct screw length (Figure 31). 19 VersaNail ® Femoral Universal Retrograde Entry and Canal Preparation Figure 32 Figure 33 Patient Positioning Entry Site and Surgical Approach Place the patient in the supine position on a fracture or radiolucent imaging table (Figure 32). Place the knee in approximately 45 degrees of flexion. Use manual traction, a femoral distractor or an external fixator to reduce severely displaced fractures and maintain length. Special attention is needed to maintain proper length when using a retrograde approach to treat a comminuted fracture. Identify the entry site, which is above the intercondylar notch (Figure 33). 20 Figure 34 Figure 35 Approach the distal femur through a midline longitudinal incision between the patella and the tibial tubercle (Figure 34). Obtain access to the intercondylar notch by splitting the tendon longitudinally or displacing the tendon laterally. Place the guide pin in the center of the intercondylar notch approximately 1 cm anterior to the posterior cruciate ligament and confirm accurate guide pin placement in two planes fluoroscopically prior to reaming. The guide pin placement should be in line with the center of the femoral canal in both views (Figure 35). Alternative approach: Approach the distal femur through a longitudinal incision from the superior pole of the patella to the tibial tubercle, placed along the medial border of the patellar tendon. Expose the intercondylar notch by using retractors to reflect the patellar tendon laterally or perform the procedure percutaneously. 21 VersaNail ® Femoral Universal Retrograde Entry and Canal Preparation Figure 36 Figure 37 Entry Site and Surgical Approach (cont.) Canal access can be obtained using either a Cannulated Entry Reamer or Cannulated Awl (2810-01-005) (Figures 36 and 37). Both 12 mm (2810-13-001) and 13 mm (2810-13-002) entry reamers are available depending on surgeon preference. The distal (drive end) nail diameter is 12 mm for all nail sizes equal to or less than 12 mm, and 13 mm to 15 mm nails have a distal diameter equal to the nail diameter. Use A/P and lateral fluoroscopic views to confirm accurate placement. Use the awl or entry reamer to open the distal femur in the intercondylar notch. As an option, an Entry Portal Sleeve (2810-12-001) is available for soft tissue protection, as great care must be taken to protect the undersurface of the patella. 22 Note: If utilizing the cannulated entry reamer, the length of the distal portion of the reamer is enlarged and matches the length of the drive end portion of the nail. Fluoroscopically verify the entry reamer has been inserted to the proper depth that will correspond with the depth of the nail. Figure 38 Figure 39 Fracture Reduction Once access to the femoral canal has been gained, place the ball nose guide wire into the entry site utilizing the pistol-style Guide Wire Gripper (2810-01-001) (Figure 38). If preferred, a T-handle Guide Wire Gripper (2810-01-002) is also available as an option. Obtain appropriate anatomic reduction in order to restore length, alignment and rotation of the injured limb. Reduction can be achieved through the surgeon’s preferred method such as traction and/or an external fixator. To aid in manipulating the fracture fragments and passing the Ball Nose Guide Wire, large (7.5 mm diameter, 2810-01-007) and small (6.5 mm diameter, 2810-01-008) reduction tools are available (Figure 39). Insert the reduction tool into the medullary canal, past the fracture site. Once the fracture is aligned, pass the Ball Nose Guide Wire, available in both 80 cm (2810-01-080) and 100 cm (2810-01-100) lengths, across the fracture site. Remove the reduction tool. 23 VersaNail ® Femoral Universal Retrograde Nail Insertion Figure 40 Figure 41 Canal Preparation Nail Size Selection Achieve proper alignment of the fracture prior to reaming and maintain it throughout the reaming process to avoid eccentric reaming. Initiate reaming by placing the VersaNail Flexible Reamers over the 3.0 mm Ball Nose Guide Wire (Figure 40). Ream the medullary canal in millimeter increments until cortical bone is reached and half-millimeter increments thereafter. Surgeon preference should dictate the actual extent of intramedullary reaming. Monitor the reaming procedure using image intensification to avoid eccentric or excessive cortical reaming. An X-ray Template (2810-13-025) including 10 percent magnification is available to determine nail size preoperatively (Figure 41). 24 Figure 42 Nail Diameter Selection Nail Length Selection Generally, a nail diameter 1 mm less than the final reamer diameter is chosen. Femoral Universal Nails are available in 1 mm increments from 9 mm to 15 mm diameters. With the tip of the ball nose guide wire at the level of the desired depth of nail insertion, slide or snap the Nail Length Gauge (2810-01-031) onto the ball nose guide wire until the nose contacts the bone, ensuring the tip does not fall into the existing entry canal, which could result in an inaccurate measurement (Figure 42). 25 VersaNail ® Femoral Universal Retrograde Nail Insertion Figure 43 Figure 44 Nail Length Selection (cont.) Nail/Jig Assembly To obtain the appropriate nail length read the measurement mark on the nail length gauge that is closest to the beginning of the black transition area on the guide wire (Figure 43). The selected nail length must be at least 5 mm less than the measured length to allow for the required recessing of the drive end of the nail, ensuring that the nail will not protrude into the patellofemoral joint. If the dynamization mode is to be used at the drive end of the nail, nail length should be further appropriately shortened. If a nail of the exact measured length is not available, choose a shorter nail of the next closest available length. A direct measurement can also be taken of the uninjured extremity using either radiographs with magnification markers, or directly on the uninjured limb. Place the nail on the femoral insertion handle in the correct orientation. The nail should be oriented on the femoral insertion handle such that the anterior bow of the nail is in line with the anterior bow of the femur and the jig is lateral to the nail. Secure the nail to the femoral insertion handle by inserting the Femoral Jig Bolt (2810-13-008) through the cannulation of the nose and tightening with the Jig Bolt Driver (2810-13-006) and T-handle (2810-01004) (Figure 44). 26 Figure 45 Figure 46 Once proper reduction has been achieved, insert the nail over the 3 mm ball nose guide wire into the medullary canal (Figure 45). It is important not to strike the femoral insertion handle directly. Attach the Hammer Pad (2810-13-011) to the insertion handle (Figure 46). Ensure that the hammer pad is tightened thoroughly prior to impaction. Avoid excessive force when inserting the nail. If the nail jams in the medullary canal, extract it and choose the next-smaller diameter nail or enlarge the canal appropriately. Nail Insertion 27 VersaNail ® Femoral Universal Retrograde Nail Insertion Nail/Jig Junction 5 mm 15 mm Figure 47 Figure 48 Nail Insertion (cont.) Dynamization Note: The femoral insertion handle is marked with three grooves (Figure 47). The groove closest to the nail is an indicator for the nail/insertion handle junction. A K-wire can be inserted lateral to medial through the target arm if additional identification of the nail/insertion handle junction is needed. The middle groove is marked 5 mm from the top of the nail and the groove farthest from the nail is marked 15 mm from the top of the nail. Ensure the nail is seated to proper depth for planned dynamization. A dynamic slot has been incorporated in the drive end and non-drive end of the nail. The drive end slot has a 10 mm range of dynamization. The non-drive end slot has a 5 mm range of dynamization. If dynamization is planned, countersink the nail to the appropriate depth to avoid backing out of the nail. Lock the M/L slot in the dynamic mode. Delayed dynamization may be performed at a later date with the removal of the static screws. Confirm fracture reduction and ensure appropriate nail insertion depth proximally and distally with biplanar fluoroscopy. Remove the ball nose guide wire. 28 Universal Target Arm Assembly Attach the radiolucent Universal Target Arm (2810-13009) onto the insertion handle, using the Target Arm Attachment Bolt (2810-13-026) and hand tighten. Ensure the target arm is properly secured to the insertion handle for excellent targeting (Figure 48). Retrograde Locking K-wire (indicator for nail/jig junction) Static Locking Hole Slot - Dynamic Mode Slot - Static Mode Static Locking Mode Figure 49 Figure 50 Figure 51 Locking Prior to locking both proximally and distally, check femoral length and rotational alignment. The nail can be locked either distally or proximally first, depending on surgeon preference. Distal Locking Place the 6.5 mm Screw Sheath (2810-13-020) and Trocar (2810-13-021) through the appropriate holes in the jig’s targeting arm to locate the incision site (Figure 51). Make a stab incision and advance the sheath and trocar to the bone. Soft tissue dissection should be completed sharp and precise to clear a path for the sheath. Undue soft tissue tension against the sheath can cause misdirect drilling. The universal target arm is marked to identify which drive end locking option is being targeted (Figure 49). Place 6.5 mm cortical locking screws using the black instrumentation (Figure 50). Note: Depending on surgeon preference, a 6.5 mm lag screw is also available for distal locking. If a lag locking technique is preferred, place the 6.5 mm cancellous lag screw using the gold instrumentation. 29 VersaNail ® Femoral Universal Retrograde Locking Figure 52 Figure 53 Figure 54 Distal Locking (cont.) Note: A 3.2 mm x 17.5 in Guide Pin (9030-03-004) and 3.2 mm Pin Guide Sleeve (2810-13-018) can be used to verify screw position prior to drilling (Figure 52). Remove the trocar and replace it with the 5.3 mm Drill Sleeve (2810-13-022) (Figure 53). 30 Utilizing the 5.3 mm Drill Bit (2810-13-153) drill through the drill sleeve and sheath until the far cortex is penetrated (Figure 54). Figure 55 Figure 56 Read the calibration on the drill bit that lines up with the drill sleeve to determine the screw length (figure 55). If further screw length is required, or if the locking hole has been initiated with a guide pin, a 6.5 mm Screw Depth Gauge (2810-13-035) is available to read screw length off of the 3.2 mm x 17.5 in guide pin (Figure 56). Ensure the drill sleeve is on bone and read the calibration on the drill bit at the end of the drill sleeve to determine the appropriate screw length (Figure 55). If penetrating the far cortex prior to taking the reading, use the screw length indicated on the drill bit at the screw depth measurement line. If you are not penetrating the far cortex prior to taking the reading, add 5 mm in length to the screw length reading. 31 VersaNail ® Femoral Universal Retrograde Locking Figure 57 Figure 58 Distal Locking (cont.) Proximal Locking Verify fluoroscopically to assure the proper screw length selection. Remove the drill sleeve. Using the 6.5 mm Screwdriver Shaft (2810-13-024), insert the 6.5 mm cortical screw through the sheath (Figure 57). The etch mark on the screwdriver corresponds with the screw sheath to indicate when the screw is fully seated. Place 4.5 mm cortical locking screws using the green instrumentation (Figure 58). Repeat above steps for additional screw placement. 32 Figure 59 Figure 60 Use fluoroscopy to conduct freehand locking utilizing a familiar freehand technique. A black Radiolucent Wand (2810-12-016) is available to aid in freehand locking (Figure 59). Accurate C-arm position is confirmed when the distal nail hole appears to be a perfect circle (Figure 60). Once correct placement has been verified fluoro-scopically, make a stab wound in direct alignment with the distal hole. 33 VersaNail ® Femoral Universal Retrograde Locking A compensation factor is built into the measurement of the screw depth gauge (for the screw head and cutting flutes), and the calibrated drills (for the screw head only). If penetrating the far cortex prior to taking the reading, use the screw length indicated on the drill bit at the screw depth measurement line. If you are not penetrating the far cortex prior to taking the reading, add 5 mm in length to the screw length reading. Figure 61 Figure 62 Proximal Locking Determining Screw Length Using the 3.8 mm Drill Bit (6 in: 2810-12-138 or 8 in: 2810-13-138), drill until the second cortex is reached or penetrated. Verify the drill bit position fluoroscopically prior to taking any measurements (Figure 61). Place the green 4.5 mm Screw Length Gauge (2810-01-032) onto the calibrated drill bit and advance down to the bone. Read the calibration on the drill bit that corresponds to the measurement line indicated on the screw length gauge. A Screw Depth Gauge (2810-01-017) is also provided for further screw length verification. For an accurate reading, take care to ensure the 4.5 mm screw length gauge or screw depth gauge sheath is fully seated on the bone. Remove the drill bit and advance the 4.5 mm screw. Repeat above steps for additional screw placement. The SolidLok Screwdriver (2810-01-020 and 2810-01-021) can be utilized to capture the screw while passing it through soft tissue during screw placement. The screw size indicates the total measurement from the tip to the screw head. The calibrated drills and the screw depth gauges have a compensation factor built into the measurement such that the reading should indicate the exact size screw to achieve bi-cortical purchase. To ensure a proper reading, the screw depth gauge and drill sleeves must be touching bone. Fluoroscopy is recommended to verify the correct screw length (Figure 62). 34 End Cap Placement and Nail Removal Figure 63 Figure 64 End Cap Placement Impinging and non-impinging cannulated end caps are provided in the system to both prevent bony ingrowth and add length when needed (Figure 63). End caps have a double hex of 5 mm and 3.5 mm and are cannulated to accept a 3.2 mm guide pin. Place the end cap into the end of the nail with the 4.5/5.5 mm Screwdriver (2810-01-015) or the SolidLok Screwdriver (2810-01-020 and 2810-01-021) (Figure 64). If the end cap will be placed using a 3.2 mm guide pin, place the end cap with the 5 mm Hex Driver (2810-01-037). Irrigate the joint to ensure that no debris remains. Close the wound. 35 VersaNail ® Femoral Universal End Cap Placement and Nail Removal Figure 65 Figure 66 Figure 67 Nail Removal If the surgeon deems it appropriate to remove the nail, a Cannulated Extractor Bolt (2810-01-023), used with 3/4 in Hex Driver (2810-01-027) and T-handle Hudson (2810-01-004), is provided to aid in nail extraction (Figure 65). Locate the top of the nail through an appropriate incision. Remove the end cap. End caps have a double hex of 5 mm and 3.5 mm and are cannulated to accept a 3.2 mm guide pin. If using the guide pin method, insert the 3.2 mm guide pin and remove the end cap using the cannulated 5 mm Hex Driver (2810-01-037), which is connected to the T-handle Hudson (2810-01-004) (Figure 66). 36 The SolidLok® Locking Screwdriver (2810-01-020 and 2810-01-021) is also available to aid in removing the end cap, if not utilizing a guide pin. Insert the SolidLok screwdriver into the Hex Tip (2810-01-019) and tighten the handle to lock the end cap’s hex tip into the inner end cap’s 3.5 mm hex (Figure 67). The end cap can also be removed with a standard 3.5 mm hex screwdriver. Make the appropriate incisions and remove all locking screws. Remove all overgrown bone around the nail’s proximal aspect to avoid iatrogenic fracture during nail extraction. Figure 68 Figure 69 Once locking screws are removed, drive a 3.2 mm guide pin into the cannulation in the nail’s proximal section. Insert the extractor bolt over the 3.2 mm guide pin and thread it into the nail (Figure 68). Then thread the impactor rod into the extractor bolt and use either the slotted mallet or sliding hammer to remove the nail (Figure 69). Figure 70 If nail removal is unobtainable utilizing the standard extractor bolt, a Conical Nail Extractor Bolt (2810-01-022) is available for removal cases where the nail threads are difficult to engage (Figure 70). This instrument is designed to work with various nail thread/cannulation designs. Note: Nail thread/cannulation condition may limit the purchase amount that can be gained using the conical extractor bolt. 37 VersaNail ® Femoral Universal Ordering Information Catalog number Description Femoral Universal Nail 9 mm 28-50 cm 1813-09-280 9 mm x 28 cm 1813-09-300 9 mm x 30 cm 1813-09-320 9 mm x 32 cm 1813-09-340 9 mm x 34 cm 1813-09-360 9 mm x 36 cm 1813-09-380 9 mm x 38 cm 1813-09-400 9 mm x 40 cm 1813-09-420 9 mm x 42 cm 1813-09-440 9 mm x 44 cm 1813-09-460 9 mm x 46 cm 1813-09-480 9 mm x 48 cm 1813-09-500 9 mm x 50 cm Femoral Universal Nail 10 mm 28-50 cm 1813-10-280 10 mm x 28 cm 1813-10-300 10 mm x 30 cm 1813-10-320 10 mm x 32 cm 1813-10-340 10 mm x 34 cm 1813-10-360 10 mm x 36 cm 1813-10-380 10 mm x 38 cm 1813-10-400 10 mm x 40 cm 1813-10-420 10 mm x 42 cm 1813-10-440 10 mm x 44 cm 1813-10-460 10 mm x 46 cm 1813-10-480 10 mm x 48 cm 1813-10-500 10 mm x 50 cm Femoral Universal Nail 11 mm 28-50 cm 1813-11-280 11 mm x 28 cm 1813-11-300 11 mm x 30 cm 1813-11-320 11 mm x 32 cm 1813-11-340 11 mm x 34 cm 1813-11-360 11 mm x 36 cm 1813-11-380 11 mm x 38 cm 1813-11-400 11 mm x 40 cm 1813-11-420 11 mm x 42 cm 1813-11-440 11 mm x 44 cm 1813-11-460 11 mm x 46 cm 1813-11-480 11 mm x 48 cm 1813-11-500 11 mm x 50 cm Femoral Universal Nail 12 mm 28-50 cm 1813-12-280 12 mm x 28 cm 1813-12-300 12 mm x 30 cm 1813-12-320 12 mm x 32 cm 1813-12-340 12 mm x 34 cm 1813-12-360 12 mm x 36 cm 1813-12-380 12 mm x 38 cm 1813-12-400 12 mm x 40 cm 1813-12-420 12 mm x 42 cm 1813-12-440 12 mm x 44 cm 1813-12-460 12 mm x 46 cm 1813-12-480 12 mm x 48 cm 1813-12-500 12 mm x 50 cm Femoral Universal Nail 13 mm 28-50 cm 1813-13-280 13 mm x 28 cm 1813-13-300 13 mm x 30 cm 1813-13-320 13 mm x 32 cm 1813-13-340 13 mm x 34 cm 1813-13-360 13 mm x 36 cm 1813-13-380 13 mm x 38 cm 1813-13-400 13 mm x 40 cm 1813-13-420 13 mm x 42 cm 1813-13-440 13 mm x 44 cm 1813-13-460 13 mm x 46 cm 1813-13-480 13 mm x 48 cm 1813-13-500 13 mm x 50 cm Femoral Universal Nail 14 mm 28-50 cm (Special Order Only) 1813-14-280 14 mm x 28 cm 1813-14-300 14 mm x 30 cm 1813-14-320 14 mm x 32 cm 1813-14-340 14 mm x 34 cm 1813-14-360 14 mm x 36 cm 1813-14-380 14 mm x 38 cm 1813-14-400 14 mm x 40 cm 1813-14-420 14 mm x 42 cm 1813-14-440 14 mm x 44 cm 1813-14-460 14 mm x 46 cm 1813-14-480 14 mm x 48 cm 1813-14-500 14 mm x 50 cm Femoral Universal Nail 15 mm 28-50 cm (Special Order Only) 1813-15-280 15 mm x 28 cm 1813-15-300 15 mm x 30 cm 1813-15-320 15 mm x 32 cm 1813-15-340 15 mm x 34 cm 1813-15-360 15 mm x 36 cm 1813-15-380 15 mm x 38 cm 1813-15-400 15 mm x 40 cm 1813-15-420 15 mm x 42 cm 1813-15-440 15 mm x 44 cm 1813-15-460 15 mm x 46 cm 1813-15-480 15 mm x 48 cm 1813-15-500 15 mm x 50 cm End Caps 1813-00-005 End Cap Universal 5 mm 1813-00-010 End Cap Universal 10 mm 1813-00-015 End Cap Universal 15 mm 1813-00-002 End Cap Universal Impinging 1813-00-001 End Cap Universal Flush Indicates outlier size not included in standard set configuration. Indicates special orders only. Not an inventory item. Packaged non-sterile only. 38 6.5 mm Self Tapping Cortical Screws Full Thread (Drive End) 1020-40 40 mm Length 1020-45 45 mm Length 1020-50 50 mm Length 1020-55 55 mm Length 1020-60 60 mm Length 1020-65 65 mm Length 1020-70 70 mm Length 1020-75 75 mm Length 1020-80 80 mm Length 1020-85 85 mm Length 1020-90 90 mm Length 1020-95 95 mm Length 1020-100 100 mm Length 8050-65-105 105 mm Length 8050-65-110 110 mm Length 8050-65-115 115 mm Length 8050-65-120 120 mm Length 6.5 mm Solid Cancellous Lag Screws (Drive End) 1030-60 60 mm Length 1030-65 65 mm Length 1030-70 70 mm Length 1030-75 75 mm Length 1030-80 80 mm Length 1030-85 85 mm Length 1030-90 90 mm Length 1030-95 95 mm Length 1030-100 100 mm Length 1030-105 105 mm Length 1030-110 110 mm Length 1030-115 115 mm Length 1030-120 120 mm Length 4.5 mm Self Tapping Cortical Screws Full Thread (Non-Drive End) 14022-24 24 mm Length 14022-28 28 mm Length 14022-32 32 mm Length 14022-36 36 mm Length 14022-40 40 mm Length 14022-44 44 mm Length 14022-48 48 mm Length 14022-52 52 mm Length 14022-56 56 mm Length 14022-60 60 mm Length 14022-65 65 mm Length 14022-70 70 mm Length 14022-75 75 mm Length 14022-80 80 mm Length (4.5 mm screws available in 2 mm increments up to 60 mm) Sterile packaged. 2 4 3 1 General 2810-01-001 Pistol Guidewire Gripper 2810-01-002 T-Handle Guidewire Gripper (optional) 2810-01-003 Slotted Mallet 2810-01-004 T-Handle Hudson 1096 Sliding Hammer 1 2 3 4 5 5 6 9 7 Canal Prep 2810-01-007 Long Reduction Tool 2810-01-008 Short Reduction Tool 2810-01-005 Curved Cannulated Awl 2810-13-004 Entry Portal Trocar 2810-13-005 Long Entry Portal 2810-13-002 13 mm Entry Reamer, Femur 2810-13-001 12 mm Entry Reamer, Femur 2810-01-025 Awl Stylus 2810-01-026 Guidewire Pusher 6 7 8 9 10 11 12 13 14 Nail Insertion 1186 3/4 in Combination Wrench 2810-13-011 Hammer Pad Femur 2810-13-026 Target Arm Attachment Bolt 2810-13-009 Universal Target Arm 2810-13-007 Femoral Insertion Handle 2810-13-006 Jig Bolt Driver, 8 mm 1095 Impactor Rod/Extraction 2810-13-047 Fem Univ Compression Bolt 2810-13-046 Compression Rod 15 16 17 18 19 20 21 22 23 10 8 11 12 13 14 15 16 19 17 18 20 22 21 23 39 VersaNail ® Femoral Universal Ordering Information Promixal Locking 2810-13-020 6.5 mm Screw Sheath 2141-49-000 AO Quick Couple Screwdriver 2810-13-024 6.5 mm Screwdriver Shaft 2810-13-035 6.5 mm Screw Depth Gauge 2810-13-018 3.2 mm Guide Pin Sleeve - Silver 2810-13-021 6.5 mm Screw Trocar 2810-13-022 5.3 mm Drill Sleeve - Black 2810-13-023 6.5/4.8 mm Step Drill Sleeve - Gold 24 25 26 27 28 29 30 31 25 24 26 27 28 29 30 31 Distal Locking 2810-01-032 4.5 mm Screw Length Gauge 2810-12-016 Freehand Distal Targ. Dev. Universal - Black 2810-01-020 SolidLok Screwdriver Handle 2810-01-015 4.5/5.5 mm Screwdriver Shaft 2810-01-017 Screw Depth Gauge 2810-01-021 SolidLok Driver Inner Shaft 32 32 33 34 35 36 37 33 34 35 36 37 Nail Removal 2810-01-023 Extractor Bolt, Tibia/Femur 2810-01-022 Conical Extractor Tool 2810-01-027 3/4 in Hex Driver 38 39 40 38 40 39 Disposables 14012-14 3.2 mm x 14 in Short Threaded Guide Pin 9030-03-004 3.2 mm x 17 1/2 in Threaded Guide Pin 2810-01-019 SolidLok Hex Tip, 3.5 mm 2810-01-080 Ball Nose Guide Wire 80 cm 2810-01-100 Ball Nose Guide Wire 100 cm 2810-12-138 3.8 mm Drill Bit 6 in, Non-sterile 2810-13-138 3.8 mm Drill Bit 8 in, Non-sterile 2810-13-153 5.3 mm Drill Bit, Non-sterile 2810-13-165 6.5/4.8 mm Step Drill Bit, Non-sterile 41 42 43 43 44 45 46 47 41 42 43 44 45 46 47 40 Cases & Trays 2810-13-030 Femoral Tray Entry & Jigs 2810-13-031 Femoral Tray Locking & Extraction 8299-10-500 Modular Screw System Outer Case 8299-10-065 6.5 mm Screw Module 8299-10-045 4.5 mm Cort Screw Module 48 49 50 51 52 Nail Measurement 1245 Radiographic Ruler 2810-01-031 Nail Length Gauge, 14 mm 2810-13-025 VersaNail Femoral Universal Template 53 54 55 Endcap Placement 2810-01-037 5.0 mm Hex Driver, Long 56 48 49 51 50 Outer Case 52 53 54 55 56 41 VersaNail ® Femoral Universal Ordering Information Flexible Reaming System Coupling design is simple,long established and easy to clean (AO and/or HUDSON). Excellent cleanability - Nitinol (NickelTitanium) alloy allows for a smooth cannulated shaft that provides the required flexibility without the cleaning problems associated with coil-cut or spring shaft designs. Small shaft diameters allow debris to be removed and transported up to the open proximal end of the medullary canal. Deep cutting flutes allow debris to be moved proximally away from the reamer head, maintaining cutting edge efficiency. Sharp side cutting edges are designed to remove bone without generating a substantial increase in temperature. Surface coating titanium nitride (TiNi) will keep cutting edge sharper longer. Ellipsoidal head shape allows the cutting edge to remove bone gradually and transport debris away, while bone chipping design decreases the size of debris, reducing canal pressure. Reverse cutting feature minimizes the potential for the reamer to catch in the medullary canal. 42 Monobloc Reamer Hudson Cat. No. Diameter 2810-02-060 6.0 mm 2810-02-065 6.5 mm 2810-02-070 7.0 mm 2810-02-075 7.5 mm 2810-02-080 8.0 mm 2810-02-085 8.5 mm 2810-02-090 9.0 mm 2810-02-095 9.5 mm 2810-02-100 10.0 mm 2810-02-105 10.5 mm 2810-02-110 11.0 mm 2810-02-115 11.5 mm 2810-02-120 12.0 mm 2810-02-125 12.5 mm 2810-02-130 13.0 mm Modular Reamer Head Cat. No. Diameter 2810-04-090 9.0 mm 2810-04-095 9.5 mm 2810-04-100 10.0 mm 2810-04-105 10.5 mm 2810-04-110 11.0 mm 2810-04-115 11.5 mm 2810-04-120 12.0 mm 2810-04-125 12.5 mm 2810-04-130 13.0 mm 2810-04-135 13.5 mm 2810-04-140 14.0 mm 2810-04-145 14.5 mm 2810-04-150 15.0 mm 2810-04-155 15.5 mm 2810-04-160 16.0 mm 2810-04-165 16.5 mm 2810-04-170 17.0 mm 2810-04-175 17.5 mm 2810-04-180 18.0 mm 2810-04-185 18.5 mm 2810-04-190 19.0 mm 2810-04-195 19.5 mm 2810-04-200 20.0 mm 2810-04-205 20.5 mm 2810-04-210 21.0 mm 2810-04-215 21.5 mm 2810-04-220 22.0 mm Nitinol Modular Reamer Shaft Hudson Cat. No. Length 2810-02-400 400 mm 2810-02-470 470 mm Reamer Extension Cat. No. Length 2810-02-015 150 mm Ball Nose Guide Wires Cat. No. Length 3.0 mm (use with 8.0-22.0 mm Reamers) 2810-01-080 2810-01-100 800 mm 1000 mm 2.0 mm (use with 6.0-7.5 mm Reamers) 2810-17-006 700 mm Flexible Reamer Case 2810-02-016 43 Notes 44 Notes 45 Screws, Plates, Intramedullary Nails, Compression Hip Screws, Pins and Wires Additional Contraindication for Retrograde Femoral Nailing: Important: A history of septic arthritis of the knee and knee extension contracture with inability to attain at least 45º of flexion. This Essential Product Information does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information. Indications: The use of metallic surgical appliances (screws, plates, intramedullary nails, compression hip screws, pins and wires) provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue. Contraindications: Screws, plates, intramedullary nails, compression hip screws, pins and wires are contraindicated in: active infection, conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process, foreign body sensitivity, and cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients. Additional Contraindication for Orthopaedic Screws and Plates only: Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. Proximal End 0 mm 29 mm 39 mm Inadequate implant support due to the lack of medial buttress. Warnings and Precautions: Bone screws and pins are intended for partial weight bearing and non-weight bearing applications. These components cannot be expected to withstand the unsupported stresses of full weight bearing. Adverse Events: The following are the most frequent adverse events after fixation with orthopaedic screws, plates, intramedullary nails, compression hip screws, pins and wires: loosening, bending, cracking or fracture of the components or loss of fixation in bone attributable to nonunion, osteoporosis, markedly unstable comminuted fractures; loss of anatomic position with nonunion or malunion with rotation or angulation; infection and allergies and adverse reactions to the device material. Surgeons should take care when targeting and drilling for the proximal screws in any tibial nail with oblique proximal screws. Care should be taken as the drill bit is advanced to penetrate the far cortex. Advancing the drill bit too far in this area may cause injury to the deep peroneal nerve. Fluoroscopy should be used to verify correct positioning of the drill bit. Additional Adverse Events for Compression Hip Screw only: Screw cutout of the femoral head (usually associated with osteoporotic bone). Distal End 12 mm Drive End Diameter for 9-12 mm Nails Drive End Diameter Equal to Nail Diameter for 13-15 mm Nails 14 mm 64 mm Additional Contraindications for Compression Hip Screws only: 48 mm 38 mm 10 mm Dymanization Range 28 mm 18 mm 54 mm 13 mm 0 mm Locking Options This publication and all content, is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Biomet Inc. or its affiliates unless otherwise indicated. This material is intended for the physicians and the Biomet sales force only. The distribution to any other recipient is prohibited. This publication must not be used, copied or reproduced in whole or in part without the express written consent of Biomet or its authorized representatives. For product information see package insert and Biomet’s website. Biomet does not practice medicine and does not recommend any particular orthopaedic implant or surgical technique and is not responsible for the kind of treatment selected for a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting prosthesis in each individual patient. Responsible Manufacturer Biomet Trauma P.O. Box 587 56 E. Bell Drive Warsaw, Indiana 46581-0587 USA ©2013 Biomet Trauma • Form No. BMET0027.1 • REV1113 www.biomet.com 5 mm Dymanization Range
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