Versa Nail Femoral Troch Surgical Technique
2016-04-01
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VersaNail Femoral Troch Entry Product Rationale & Surgical Technique One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it’s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled. VersaNail Femoral Troch Entry Nailing System Contents Design Summary........................................................................................................................................................... 3 Femoral Troch Entry Nailing System............................................................................................................................. 4 Implant Overview.......................................................................................................................................................... 6 Entry and Canal Preparation......................................................................................................................................... 7 Nail Insertion............................................................................................................................................................... 10 Locking........................................................................................................................................................................ 11 End Cap Placement.................................................................................................................................................... 15 Nail Removal............................................................................................................................................................... 16 Ordering Information................................................................................................................................................... 17 Flexible Reaming System............................................................................................................................................ 21 1 VersaNail Femoral Troch Entry Nailing System 2 VersaNail Femoral Troch Entry Nailing System Engineered to match the patient’s natural anatomy Anatomically designed to aid insertion by navigating around the proximal femur Multiple locking options for the treatment of simple to complex subtrochanteric to distal femoral shaft fractures Unique distal bend centers the nail properly in the intramedullary canal, reducing the potential for distal cortex penetration The Biomet VERSANAIL Troch Entry Femoral Nail is part of a long bone nailing system that offers a complete portfolio of implants and instruments based on a standardized technology platform. The Troch Entry Nail from the VERSANAIL Platform offers an implant design to treat femoral fractures with unique and versatile locking options. This femoral nail incorporates an excellent anatomic design for insertion through the greater trochanter. The VERSANAIL Platform instrumentation is designed to provide options and flexibility for many intraoperative approaches (including percutaneous methods) while maintaining ease-of-use and commonality. 3 VersaNail Femoral Troch Entry Nailing System The Troch Entry Nail is intended to treat: • Pathologic fractures in osteoporotic bone of the trohchanteric and diaphyseal areas • Proximal, middle and distal third fractures • Severely comminuted shaft fractures extending beyond the isthmus • Proximal or distal non-unions and malunions • Spiral, long oblique and segmental fractures • Leg length discrepancies secondary to femoral inequality • Non-unions and malunions • Femur reconstruction following tumor resection • Lengthening of the bone • Stable femoral fractures without necessity for interlocking • Fractures with bone loss • Long subtrochanteric fractures • Bi-lateral fractures • Revision procedures involving the replacement of implanted hardware. • Pseudoarthrosis of the femoral shaft • Supracondylar fractures • Subtrochanteric fractures with or without involvement of lesser trochanter Enlarged nail cannulation accepts the ball nose guide • Subtrochanteric / intertrochanteric combination fractures 2.2 meter radius of curvature accommodates • Ipsilateral femoral shaft and neck fractures the anterior bow of the femur. wire, eliminating the need for an exchange tube. • Stable and unstable proximal fractures of the femur including pertrochanteric fractures • Intertrochanteric fractures • High subtrochanteric fractures and combinations of these fractures • Pertrochanteric fractures associated with shaft fractures 4.5 or 5.0 mm distal screw options. Distal 5° bend (for 9 mm nails) and 3° bend (for 11 mm and 13 mm nails) facilitate ease of insertion through the proximal intertrochanteric/ subtrochanteric region. Chamfer on the front of the distal tip facilitates insertion, and decreases the risk of anterior cortex penetration in the distal femur. 4 6º Proximal locking options allow for 2.5º Anterior two screws into the femoral head or 22 mm Proximal End 13 mm Distance 0 mm one screw from the greater to lesser trochanter. 15 mm 32 mm Unique crosslocking option allows for 45 mm 125º one recon screw and one antegrade screw at the same time, providing multi-planar fixation. Large core diameter of the proximal 6.5 mm screws decreases risk for screw breakage. 125° neck shaft angle facilitates screw placement into the femoral head. Proximal 2.5° anterior bend and 6° lateral bend 41 mm provide optimal anatomic fit in the proximal femur. 18 mm 13 mm 0 mm 5 mm 8° of anteversion for anatomic proximal screw. 5º - 9 mm Nail 3º - 11, 13 mm Nails Multiple locking options for optimum implant stability The Troch Entry Femoral Nail screw portal configurations provide a number of proximal locking possibilities. The Troch Entry Nail is locked with 6.5 mm screws proximally and 4.5 or 5.0 mm screws distally. The locking instrumentation is color-coded for ease of use: 5 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 Green 5.0 mm Cortical 4.3 mm VersaNail Femoral Troch Entry Nailing System Figure 2a Figure 1 Figure 2b Implant Overview The Troch Entry Femoral Nail incorporates multiple bends for an excellent anatomic fit. It is designed to facilitate ease of insertion through the greater trochanter (Figure 1). The distal bend, in line with the anterior bow of the nail, is designed to negotiate the anatomic curve of the greater trochanteric and subtrochanteric entry into the femoral canal (Figure 2a). Once fully seated in the femoral canal, the distal bend angles posteriorly, reducing potential stress on the anterior cortex (Figure 2b). 6 Figure 5 Figure 3 Figure 6 Figure 4 Entry and Canal Preparation Patient Positioning Place the patient in the supine or lateral position on either a fracture or radiolucent imaging table, depending on surgeon preference. Lateral access to the proximal femur is required. The affected leg must be abducted and the trunk secured. The contralateral leg may be flexed at the hip or scissored below the affected leg (Figure 3). Confirm correct entry location and guide pin placement radiographically with AP and lateral views. The guide pin should be in line with the femoral canal in the lateral view and angled approximately 6 degrees in the AP view. Care should be taken to ensure that the guide pin and channel reamer do not migrate laterally, causing varus malalignment (Figure 5). Surgical Approach and Entry Point Once the ideal entry point has been achieved, extend the entry incision to 1-2 cm. The fascia lata is divided along its fibers (Figure 6). Reference the greater trochanter. Identify the entry site, which is at the tip of the greater trochanter. 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 (Figure 4). 7 VersaNail Femoral Troch Entry Nailing System Figure 8 Figure 7 Figure 9 Canal Entry The entry site can be made using either an entry reamer or 10.5 mm diameter cannulated awl. Troch Entry Nails have a proximal diameter of 13 mm which extends 6 cm. The entry reamers have an enlarged section that matches the proximal section of the nail. This allows the final depth of the entry reamer to be visualized fluoroscopically. Both 13 mm and 14 mm entry reamers are available depending on surgeon preference (Cat. No. 2810-13-002 or 281013-003). An excellent starting hole is especially important when nailing proximal fracture patterns, those with short segments and/or medial comminution. Use AP and lateral fluoroscopic views to confirm accurate placement. Use the Awl (Cat. No. 2810-01-005) or entry reamer to open the proximal femur at the greater trochanter. If required, the Entry Portal Sleeve (Cat. No. 2810-13-005) is available for soft tissue protection (Figure 8). The entry portal sleeve and trocar can be advanced over the guide pin down to the tip of the greater trochanter. Parallel guide holes allow for accurate adjustment of pin positioning. (See image for example). Remove the trocar from the entry portal, keeping the guide pin in place (Figure 7). Once access to the femoral canal has been gained, place the ball nose guide wire into the entry site utilizing the guide wire gripper. Two guide wire gripper styles are available depending on surgeon preference: the Pistol Grip (Cat. No. 2810-01001) or the T-handle Grip (Cat. No. 2810-01-002) (Figure 9). 8 Figure 11 Figure 10 Figure 12 Fracture Reduction Canal Preparation Obtain appropriate anatomic reduction in order to restore length, anatomic axis alignment and rotation of the injured limb. Reduction can be achieved through the surgeon’s preferred method such as traction, external fixator, external aids or joysticks. To aid in manipulating the fracture fragments and passing the Ball Nose Guide Wire, large (7.5 mm diameter, Cat. No. 2810-01-007) and small (6.5 mm diameter, Cat. No. 2810-01-008) reduction tools are available. Achieve proper alignment of the injured limb prior to reaming and maintain it throughout the reaming process to avoid eccentric reaming. Commence reaming by placing the VERSANAIL flexible reamer over the Biomet ball nose guide wire (Figure 11). Ream the medullary canal in millimeter increments until cortical bone is reached and in 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 in alignment, pass the Ball Nose Guide Wire, available in both 80 cm (Cat. No. 2810-01-080) and 100 cm (Cat. No. 2810-01-100) lengths, across the fracture site. Remove the reduction tool (Figure 10). An X-ray template is available to determine nail size preoperatively (Cat. No. 2810-13-033, right, and Cat. No. 2810-13-034, left) (Figure 12). 9 VersaNail Femoral Troch Entry Nailing System Nail Insertion Figure 13 Figure 14 Nail Diameter Selection Nail Insertion In general, a nail diameter 1 to 1.5 mm less than the final reamer diameter is chosen. Troch Entry Nails are available in 9, 11 and 13 mm diameters. The Troch Entry Nail is available in side specific (right or left) sizes. Ensure that the appropriate nail is chosen depending on the side of the injury. Place the nail on the femoral jig in the correct orientation (the proximal lateral bend should angle toward the jig such that the anterior bow of the nail corresponds with the anterior bow of the femur). Secure the nail to the jig by inserting the Jig Bolt (Cat. No. 2810-13-008) through the cannulation of the jig nose and tightening with the Flexible Jig Bolt Driver (Cat. No. 2810-13-037) and T-handle (Cat. No. 2810-01-004). The flexibility of the jig bolt driver allows 30° of angularity away from the patients side when removing the targeting jig from the nail. Check jig alignment with sleeves and drill bit prior to implanting (Figure 14). Nail Length Selection 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 (Cat. No. 2810-01-031) onto the ball nose guide wire until it contacts the bone, ensuring that the tip does not fall into the existing trochanteric entry canal, thus providing an inaccurate measurement. 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 13). 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. 10 Left side antegrade lock Right side antegrade lock Guidepin hole to indicate nail-jig junction Left side recon lock Right side recon lock The radiolucent target arm is etched to indicate right and left specific target holes for antegrade and recon locking modes Figure 16 Figure 15 Locking Locking Prior to locking both proximally and distally, adjust traction, and check femoral length and rotational alignment. Insert the nail over the 3 mm ball nose guide wire into the medullary canal. Take care not to strike the jig or targeting arm with the mallet. Instead use the Hammer Pad (Cat. No. 2810-13-011) with the impaction rod and slotted mallet. It may be helpful to preliminarily insert the trochanteric nail utilizing its bow to facilitate clearance of the medial femoral cortex of the proximal fragment. To do this, rotate the insertion jig anteriorly (towards the ceiling). In this position the distal bend in the nail will be angled laterally to aid in passing the nail through the greater trochanteric entry site, and avoid medial cortical penetration. As the nail passes the medial cortex of the proximal fragment, slowly derotate the jig handle into the usual lateral position, so that the anterior bow of the nail now corresponds with the anterior bow of the femur. If the nail requires substantial force to advance, remove it and ream an additional millimeter. Avoid excessive force when inserting the nail (Figure 15). Confirm fracture reduction and ensure appropriate nail insertion depth proximally and distally with biplanar fluoroscopy. Remove ball nose guide wire. Proximal Locking Attach the radiolucent targeting arm to the femoral jig and tighten using the knob on the targeting arm. Ensure that targeting arm is properly secured to the jig for accurate targeting. Prior to drilling, check jig position to ensure that the jig has not externally rotated. The same targeting arm can be used for both left and right nails and is marked to identify which locking option is being targeted (Figure 16). 11 VersaNail Femoral Troch Entry Nailing System Figure 18 Figure 17 Figure 19 It is important to recheck the AP and lateral views of the hip prior to inserting locking screws directed into the femoral head. A 3.2 mm x 17.5 in Guide Pin (Cat. No. 903003-004) and guide pin sleeve (Cat. No. 2810-13-018) are available to check screw positioning prior to drilling (Figure 17). A measurement can be taken from the guide pin using the 6.5 mm Screw Depth Gauge (Cat. No. 2810-13-035) (Figure 18). Place the 6.5 mm proximal locking screws with the locking instrumentation. The 6.5 mm solid cortical screws are drilled with a 5.3 mm drill bit. The 5.3 mm drill bit and corresponding drill sleeve are color-coded black. The 6.5 mm/4.8 mm step drill bit and corresponding drill sleeve are color-coded gold (Figure 19). Caution: Utilize fluoroscopy when drilling into the femoral head so as to not penetrate the subchondral bone. As noted above, a 3.2 mm x 17.5 in Guide Pin (Cat. No. 9030-03-004) and Guide Pin Sleeve (Cat. No. 2810-13-018) are available to check screw positioning prior to drilling. 12 Figure 22 Figure 20 Figure 21 Figure 23 Place the 6.5 mm Screw Sheath (Cat. No. 2810-13020) and Trocar (Cat. No. 2810-13-021) through the appropriate hole in the targeting jig to locate the incision site. Make a stab incision and advance the sheath and trocar to the bone (Figure 20). Ensure that 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 22). 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. Remove the trocar and replace it with the 5.3 mm Drill Sleeve (Cat. No. 2810-13-022). Using the 5.3 mm drill bit through the drill sleeve, drill until the far cortex is either reached or penetrated (Figure 21). After selecting the appropriate screw, insert the screw through the sheath using the screwdriver. The etch mark on the screwdriver corresponds with the screw sheath to indicate when the screw is fully seated (Figure 23). Repeat above steps for additional screw placement. 13 VersaNail Femoral Troch Entry Nailing System Distal Screw Drill Options 4.5 mm Screw 5.0 mm Screw 3.8 mm Drill Bit Cat. No. 2810-121-38 (6 in.) Cat. No. 2810-131-38 (8 in.) 4.3 mm Short Graduated Drill Cat. No. 2112-014-06 Distal Screw Depth Gauge Options Figure 24 4.5 mm Screw 5.0 mm Screw Screw Length Gauge Cat. No. 2810-010-32 Drill Measuring Sleeve Cat. No. 2112-014-10 Screw Depth Gauge Cat. No. 2810-010-17 Distal Screw Driver Options 4.5 mm Screw 5.0 mm Screw 4.5/5.5 mm Screwdriver Shaft Cat. No. 2810-010-15 SolidLok Screwdriver Cat. No. 2810-010-19, 2810-010-20, 2810-010-21 Figure 25 Distal Locking If using a 4.5 mm screw: Place the green 4.5 mm Screw Length Gauge (Cat. No. 2810-010-32) onto the calibrated drill bit (Cat. No. 2810-121-38 or 2810-131-38) 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. Prior to locking distal screws check femoral length and rotation under fluoroscopy. Distal locking should be conducted using the standard image intensification freehand technique. A white Radiolucent Targeting Wand (Cat. No. 1201) is available if desired (Figure 24). Either a 4.5 mm or 5.0 mm distal screw may be utilized. Using the drill bit that corresponds to the screw diameter of choice, drill until the far cortex is either reached or penetrated. Verify the drill bit position fluoroscopically prior to taking any measurements (Figure 25). If using a 5.0 mm screw: Use the short 4.3 mm graduated drill (Cat. No. 2112-014-06) and the 4.3 mm drill measuring sleeve (Cat. No. 2112-014-10). Read the calibration directly off of the 4.3 mm graduated drill by using the drill measuring sleeve. The measurement should be taken from the end of the measuring sleeve that is closest to the power source. A Screw Depth Gauge (Cat. No. 2810-01-017) is provided to determine the screw length for either a 4.5 mm or 5.0 mm screw. The following alternative distal screw measurement techniques are also available depending on which diameter screw is utilized: To ensure an accurate reading, each screw measuring tool should be fully seated on bone. The use of fluoroscopy is recommended to verify the correct screw length. Remove the drill bit and advance either the 4.5 mm or 5.0mm screw using the SolidLok Screwdriver (Cat. No. 2810010-19, 2810-010-20, 2810-010-21) or screwdriver shaft (Cat. No. 2810-010-15). Repeat above steps for additional screw placement. 14 End Cap Placement Figure 26 Figure 27 End Cap Placement Cannulated end caps are provided in the system to both prevent bony ingrowth and add length when needed (Figure 26). Place the end cap into the end of the nail with the 4.5 mm screwdriver. If the end cap will be placed using a 3.2 mm Guide Pin (Cat. No. 14012-14), place the end cap with the 5 mm Jig Bolt Driver (Cat. No. 2810-01-011). End caps have a double hex of 5 mm and 3.5 mm and are cannulated to accept a 3.2 mm guide pin. A non-cannulated locking screwdriver is also available to aid in end cap placement (Figure 27). Irrigate the wound and perform a layered closure in the usual fashion. 15 VersaNail Femoral Troch Entry Nailing System Nail Removal Figure 30 Figure 28 Figure 29 Figure 31 If the surgeon deems it appropriate to remove the nail, a Cannulated Extractor Bolt (Cat. No. 2810-01-023), used with a 3/4 in Hex Driver (Cat. No. 2810-01-027) and a T-handle Hudson (Cat. No. 2810-01-004), is provided to aid in nail extraction (Figure 28). 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. Once the locking screws have been 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. Ensure that the extractor is fully threaded into the nail prior to extraction. Then thread the impactor rod into the extractor bolt and use either the slotted mallet or sliding hammer to remove the nail (Figure 30). During nail removal it may be helpful to gently counter-rotate the nail as it is being extracted such that the distal and anterior nail contours rotate laterally to aid in removing the nail through the proximal portion of the femur and trochanteric entry portal. 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. Insert the 3.2 mm guide pin and remove the end cap using the Cannulated Jig Bolt Driver (Cat. No. 281001-011) (Figure 29). The SolidLok Locking Screwdriver (Cat. No. 2810-01020 and Cat. No. 2810-01-021) is also available to aid in removing the end cap. Insert the SolidLok screwdriver into the Hex Tip (Cat. No. 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. The end cap can also be removed with a standard 3.5 mm hex screwdriver. A Conical Nail Extractor Bolt (Cat. No. 2810-01-022) is also available for removal in cases where the nail threads are difficult to engage (Figure 31). 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. 16 Ordering Information Cat. No. Rights Cat. No. Lefts Description Femoral Troch Entry Nail 9 mm 28-50 cm 1814-09-280 1815-09-280 9 mm x 28 cm 1814-09-300 1815-09-300 9 mm x 30 cm 1814-09-320 1815-09-320 9 mm x 32 cm 1814-09-340 1815-09-340 9 mm x 34 cm 1814-09-360 1815-09-360 9 mm x 36 cm 1814-09-380 1815-09-380 9 mm x 38 cm 1814-09-400 1815-09-400 9 mm x 40 cm 1814-09-420 1815-09-420 9 mm x 42 cm 1814-09-440 1815-09-440 9 mm x 44 cm 1814-09-460 1815-09-460 9 mm x 46 cm 1814-09-480 1815-09-480 9 mm x 48 cm 1814-09-500 1815-09-500 9 mm x 50 cm Description 1020-95 1020-100 8050-65-105 8050-65-110 8050-65-115 8050-65-120 95 mm Length 100 mm Length 105 mm Length 110 mm Length 115 mm Length 120 mm Length 4.5 mm Self Tapping Cortical Screws Full Thread (Distal) 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. Femoral Troch Entry Nail 11 mm 28-50 cm 1814-11-280 1815-11-280 11 mm x 28 cm 1814-11-300 1815-11-300 11 mm x 30 cm 1814-11-320 1815-11-320 11 mm x 32 cm 1814-11-340 1815-11-340 11 mm x 34 cm 1814-11-360 1815-11-360 11 mm x 36 cm 1814-11-380 1815-11-380 11 mm x 38 cm 1814-11-400 1815-11-400 11 mm x 40 cm 1814-11-420 1815-11-420 11 mm x 42 cm 1814-11-440 1815-11-440 11 mm x 44 cm 1814-11-460 1815-11-460 11 mm x 46 cm 1814-11-480 1815-11-480 11 mm x 48 cm 1814-11-500 1815-11-500 11 mm x 50 cm 5.0 mm Self Tapping Cortical Screws Full Thread (Distal) 8145-50-020 20 mm Length 8145-50-022 22 mm Length 8145-50-024 24 mm Length 8145-50-026 26 mm Length 8145-50-028 28 mm Length 8145-50-030 30 mm Length 8145-50-032 32 mm Length 8145-50-034 34 mm Length 8145-50-036 36 mm Length 8145-50-038 38 mm Length 8145-50-040 40 mm Length 8145-50-042 42 mm Length 8145-50-044 44 mm Length 8145-50-046 46 mm Length 8145-50-048 48 mm Length 8145-50-050 50 mm Length 8145-50-052 52 mm Length 8145-50-054 54 mm Length 8145-50-056 56 mm Length 8145-50-058 58 mm Length 8145-50-060 60 mm Length 8145-50-065 65 mm Length 8145-50-070 70 mm Length 8145-50-075 75 mm Length 8145-50-080 80 mm Length Femoral Troch Entry Nail 13 mm 28-50 cm 1814-13-280 1815-13-280 13 mm x 28 cm 1814-13-300 1815-13-300 13 mm x 30 cm 1814-13-320 1815-13-320 13 mm x 32 cm 1814-13-340 1815-13-340 13 mm x 34 cm 1814-13-360 1815-13-360 13 mm x 36 cm 1814-13-380 1815-13-380 13 mm x 38 cm 1814-13-400 1815-13-400 13 mm x 40 cm 1814-13-420 1815-13-420 13 mm x 42 cm 1814-13-440 1815-13-440 13 mm x 44 cm 1814-13-460 1815-13-460 13 mm x 46 cm 1814-13-480 1815-13-480 13 mm x 48 cm 1814-13-500 1815-13-500 13 mm x 50 cm End Caps 1813-00-001 1813-00-005 1813-00-010 1813-00-015 Cat. No. End Cap Universal Flush End Cap Universal 5 mm End Cap Universal 10 mm End Cap Universal 15 mm 6.5 mm Self Tapping Cortical Screws Full Thread (Proximal) 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 Indicates outlier size not included in standard set configuration. Indicates special orders only. Not an inventory item. Packaged non-sterile only. Sterile packaged. 17 VersaNail Femoral Troch Entry Nailing System 2 4 3 1 General 2810-01-001 2810-01-002 2810-01-003 2810-01-004 1096 Pistol Guidewire Gripper 1 T-Handle Guidewire Gripper (optional) 2 Slotted Mallet 3 T-Handle Hudson 4 Sliding Hammer 5 Canal Prep 2810-01-008 2810-01-007 2810-01-005 2810-01-025 2810-01-026 2810-13-002 2810-13-003 2810-13-004 2810-13-005 Short Reduction Tool Long Reduction Tool Curved Cannulated Awl Awl Stylus Guidewire Pusher 13 mm Entry Reamer, Femur 14 mm Entry Reamer, Femur Entry Portal Trocar Long Entry Portal 6 7 8 9 10 11 12 13 14 Nail Insertion 1186 2810-13-037 2810-13-008 1095 2810-13-010 2810-13-007 2810-13-011 2810-13-026 3/4 in. Combination Wrench Flexible Jig Bolt Driver Femoral Jig Bolt Impactor Rod/Extraction Troch Entry Target Arm Femoral Insertion Handle Hammer Pad Femur Target Arm Attachment Bolt 15 16 17 18 19 20 21 22 5 6 7 8 9 10 11 14 12 13 15 20 16 17 21 18 22 19 18 Proximal Locking 2810-13-020 6.5 mm Screw Sheath 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 2141-49-000 AO Quick Couple Screwdriver 2810-13-024 6.5 mm Screwdriver Shaft 2810-13-035 6.5 mm Screw Depth Gauge Distal Locking 1201 Freehand Distal Targ. Dev. Troch Entry - White 2810-01-032 4.5 mm Screw Length Gauge 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 23 24 25 26 27 28 29 30 31 32 33 34 35 36 28 23 29 30 24 26 25 27 31 34 32 35 33 36 Nail Removal 2810-01-023 Extractor Bolt, Tibia/Femur 2810-01-022 Conical Extractor Tool 2810-01-027 3/4 in Hex Driver 37 38 39 37 39 38 Disposables 14012-14 2810-01-019 9030-03-004 2810-01-100 2810-12-138 2810-13-138 2810-13-153 2810-13-165 2112-01-406 2112-01-410 3.2 mm x 14 in Short Threaded Guide Pin SolidLok Hex Tip, 3.5 mm 40 3.2 mm x 17 1/2 in Threaded Guide Pin 41 Ball Nose Guide Wire 100 cm 42 3.8 mm Drill Bit 6 in, Non-sterile 43 3.8 mm Drill Bit 8 in, Non-sterile 44 5.3 mm Drill Bit, Non-sterile 45 6.5/4.8 mm Step Drill Bit, Non-sterile 46 4.3 mm Distal Graduated Drill Short 47 4.3 mm Drill Measuring Sleeve 48 40 41 42 43 44 45 46 47 48 19 VersaNail Femoral Troch Entry Nailing System Cases & Trays 2810-13-030 2810-13-031 8299-10-500 8299-10-065 8299-10-045 47 Femoral Tray Entry & Jigs Femoral Tray Locking & Extraction Modular Screw System Outer Case 6.5 mm Screw Module 4.5 mm Cort Screw Module 47 48 49 50 51 Nail Measurement 1245 Radiographic Ruler 2810-01-031 Nail Length Gauge, 14 mm 2810-13-033 VERSANAIL Troch Entry Template - Right 2810-13-034 VERSANAIL Troch Entry Template - Left 1815-99-380 TEN Femoral DNI 11 mm x 38 cm 52 53 54 54 48 50 51 49 Outer Case 52 53 54 Endcap Placement 2810-01-037 5.0 mm Hex Driver, Long 55 55 20 Flexible Reaming System 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 Coupling design is simple, long established and easy to clean (AO and/or HUDSON). Excellent cleanability - Nitinol (Nickel-Titanium) 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. Nitinol Modular Reamer Shaft Hudson Cat. No. Length 2810-02-400 400 mm 2810-02-470 470 mm Deep cutting flutes allow debris to be moved proximally away from the reamer head, maintaining cutting edge efficiency. Reamer Extension Cat. No. Length 2810-02-015 150 mm Sharp side cutting edges are designed to remove bone without generating a substantial increase in temperature. Ball Nose Guide Wires Cat. No. Length Surface coating titanium nitride (TiNi) will keep cutting edge sharper longer. 3.0 mm (use with 8.0-22.0 mm Reamers) 2810-01-080 2810-01-100 800 mm 1000 mm 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. 2.0 mm (use with 6.0-7.5 mm Reamers) 2810-17-006 700 mm Flexible Reamer Case 2810-02-016 Reverse cutting feature minimizes the potential for the reamer to catch in the medullary canal. 21 Important: 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. The use of metallic surgical appliances (screws, plates, intramedullary nails, compression hip screw, pins and wires) provies the orthopaedic surgeon 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. Indications: The VersaNail Femoral Troch entry is indicated to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. 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 Retrograde Femoral Nailing: A history of septic arthritis of the knee and knee extension contracture with inability to attain at least 45º of flexion. 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. Distal End Proximal End 6º Lateral 2.5º Anterior Proximal End 13 mm 22 mm Distance 0 mm 41 mm 15 mm 32 mm 5 mm 45 mm 5º - 9 mm Nail 125º 18 mm 13 mm 0 mm 3º - 11, 13 mm Nails Locking Options This material is intended for health care professionals and the Biomet sales force only. Distribution to any other recipient is prohibited. All content here in 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 must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Biomet. Check for country product clearances and reference product specific instructions for use. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert and Biomet’s website. This technique was prepared in conjunction with a licensed health care professional. Biomet does not practice medicine and does not recommend any particular orthopedic implant or surgical technique for use on a specific patient. The surgeon is responsible for determining the appropriate device(s) and technique(s) for each individual patient. Not for distribution in France. Legal Manufacturer Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA ©2014 Biomet Trauma • Form No. BMET0032.0-GBL • REV0714 www.biomet.com Authorised Representative Biomet UK Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK 0086
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