L1641_A TriCor Surg Tech L1641 A Tri Cor Sacroiliac Joint Fusion System
2014-10-16
: Pdf L1641 A - Tricor Sacroiliac Joint Fusion System Surgtech L1641_A_-_TriCor_Sacroiliac_Joint_Fusion_System_SurgTech 10 2014 pdf
Open the PDF directly: View PDF 
.
Page Count: 32
| Download | |
| Open PDF In Browser | View PDF |
TriCor™ Sacroiliac Joint Fusion System Surgical Technique 2 TriCor Sacroiliac Joint Fusion System – Surgical Technique TriCor Sacroiliac Joint Fusion System Surgical Technique Description, Indications & Contraindications . . . . . . . . . . . . . . . . . . 3 Anatomy Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Imaging Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Intraoperative Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Pre-Op Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Open Surgical Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Tissue Shield Surgical Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Implant Removal and Adjustment Surgical Technique. . . . . . . . . . . 27 Instrument Visual Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Tray Layouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 TriCor Sacroiliac Joint Fusion System – Surgical Technique Description, Indications & Contraindications INTRODUCTION The TriCor System allows for fusion and stabilization of the SI Joint in eligible patients where appropriate non-surgical treatment has failed. The TriCor Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The device optionally incorporates a proprietary dual-pitch compression-thread design and titanium plasma coating to stabilize the SI Joint in fusion procedures. The design of the implant allows for bone graft to be introduced into the joint and implant in order to promote fusion. The TriCor System is a true bony fusion and arthrodesis system. The implant and instrumentation suite allows for direct exposure and preparation of the SI Joint surface, placement of bone graft into the SI Joint space under direct visualization, and placement of bone graft directly within the TriCor Implant itself. 1. Patients with probable intolerance to the materials used in the manufacture of this device. The TriCor System consists of different diameter implants in various lengths and thread configurations to accommodate variations in patient anatomy. The TriCor Sacroiliac Joint Fusion System is manufactured from titanium alloy in accordance with ASTM F136, as well as an optional version where exterior surfaces are coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. All implants are intended as single use only and should not be reused under any circumstances. 7. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. Note: 12.5mm anchor implants are plasmacoated, 7mm locking implants are not coated. INDICATIONS The TriCor Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. 2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome. 3. Patients resistant to following postoperative restrictions on movement, especially in athletic and occupational activities. 4. Use with components from other systems. 5. Grossly distorted anatomy caused by congenital abnormalities. 6. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 8. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 9. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 10. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 11. Any case not described in the indications for use. 12. Reuse or multiple uses. CONTRAINDICATIONS Contraindications for the TriCor Joint Fusion System are similar to those of other systems of similar design, and include, but are not limited to: 3 4 TriCor Sacroiliac Joint Fusion System – Surgical Technique Anatomy Overview Structural Anatomy Sacroiliac Joint • Bicondylar synovial joint • Joins the sacrum to the pelvis Ilium Ilium • Weight-bearing, shock absorber • “Kidney-bean” shape SI Joint SI Joint • Strengthens ligamentous support and irregular articular surfaces help to resist shear forces Sacrum SI Joint TriCor Sacroiliac Joint Fusion System – Surgical Technique 5 Imaging Techniques Lateral View 1 Posterior Sacral Wall (PSW) 1 2 Ala (2 lines superimposed) 3 Anterior Sacral Wall 6 3 4 Inferior Endplate L5 5 Superior Endplate S1 6 Greater Sciatic Notch 2 4 5 Inlet View (20-25 degrees Caudally) 1 SI Joint 1 2 S1 Foramen 3 S2 Foramen 4 4 L5 Nerve 2 5 Pelvic Brim 3 5 Outlet View (40-60 degrees Cephalad) 1 SI Joint 3 2 Superior Alar Surface 4 3 Inferior Endplate of L5 4 Superior Endplate of S1 5 S1 Foramen 6 S2 Foramen 2 5 1 6 6 TriCor Sacroiliac Joint Fusion System – Surgical Technique Patient Preparation Sacral Canal Posterior sacral wall Sacral notch SI joint S1 foramen Anterior sacral wall Ala S2 foramen Greater sciatic notch Superior endplate S1 Inferior endplate L5 Inferior endplate L5 SI joint Superior endplate S1 L5 nerve TriCor Sacroiliac Joint Fusion System – Surgical Technique 7 Intraoperative Imaging Lateral View Inlet View Outlet View In order to obtain a true lateral view, align the alae so they are superimposed over one another. Tilt the C-Arm until a clear, strong pelvic brim is seen; the anterior wall of the sacrum will appear as one line. The SI joint, ilium, sacrum and sacral foramen will be visible. Pre-Op Planning Operating Room Setup • Patient positioned in a prone position • Jackson or Flat table preferably • C-Arm positioned on non-operative side 8 TriCor Sacroiliac Joint Fusion System – Surgical Technique Open Posterior Skin Incision Lateral Skin Marking and Incision Surgical Technique 1 2 Fig. 1 S Fig. 2 S Step 1 Step 2 Make an incision along the posterior two-thirds of the iliac crest following the posterior superior iliac spine. Use preferred retraction method to access and visualize the symptomatic SI joint. Cut into the ilium and remove a block of bone as well as any necessary cartilage. Once the cartilage removal is complete, place the bone back so it contacts the sacral bone. Make sure the block is secure in order to prepare for the SI joint for bony arthrodesis. (Fig. 1) Use the Exchange Pin to mark the Posterior Sacral Wall (PSW, #1) and Sacral Alar Line (#2) with a marking pen. NOTE: The Right Angled Curette or any other preferred medical instruments may be used to decorticate, remove cartilage and prepare the SI joint for bony arthrodesis. Instruments Trocar Steinmann Pin 07.02212.021 (X079-0054) #1 Tissue Shield 07.02212.016 (X079-0045) Make a skin incision along the Posterior Sacral Wall, approximately 3-5cm in length, starting at intersection with sacral ala skin marking. Beginning in the Lateral View, take the Trocar Steinmann Pin and insert the Steinmann Pin through the skin incision approximately 1cm anterior to the Posterior Sacral Wall and 1cm inferior to the ala. (Fig. 2) NOTE: Use the #1 Tissue Shield to stabilize the Trocar Steinmann Pin for impaction. TriCor Sacroiliac Joint Fusion System – Surgical Technique 9 Steinmann Pin Placement Fig. 3a S Fig. 3b S Fig. 3c S Step 3 Inlet View The angle of the Trocar Steinmann Pin should be heading towards the middle of the sacrum. (Fig. 3b) Outlet View The Trocar Steinmann Pin should be parallel to S1 endplate. Mallet the Steinmann Pin in final desired depth in Outlet view. (Fig. 3c) Confirm placement in three views: Lateral View Place the Trocar Steinmann Pin approximately 1cm Anterior to the PSW and 1cm inferior to the ala. (Fig. 3a) Instruments Mallet 07.02212.019 (X034-0915) NOTE: Blunt or Threaded Steinmann Pins are available to replace the Trocar Steinmann Pin after placement, if desired. 10 TriCor Sacroiliac Joint Fusion System – Surgical Technique Measure Drill Assembly Drill Fig. 4 S Fig. 5 S Fig. 6 S Step 4 Step 5 Step 6 Position #2 or #3 Tissue Shield over the Steinmann Pin. While keeping the Tissue Shield in place, use the Steinmann Pin Depth Gage/Guide to select the appropriate implant. Insert the Steinmann Pin Depth Gage/Guide underneath the inserted Steinmann Pin and dock onto the proximal end of the Tissue Shield. Measure with the #3 Tissue Shield for 12.5mm Implants and measure with #2 Tissue Shield for 7mm implants. Remove the Tissue Shield. (Fig. 4) Attach the Drill bit to the Ratcheting T-Handle or cordless power drill using the provided Jacobs Chuck. (Fig. 5) Place the Drill bit over the Steinmann Pin slowly advancing until the ilium is reached. Make sure the Drill is co-linear with the pin to avoid binding on the pin. NOTE: Make sure the flat portion of the Jacobs Chuck attachment fits flush to the walls if using a cordless power drill. NOTE: The drill flutes are designed to capture the autogenous bone graft for reuse in the 12.5mm anchor implant. Using the Outlet view, confirm accurate placement of the Drill Bit over the Steinmann Pin. Under fluoroscopic guidance continue to advance the Drill just across the sacroiliac joint, through the sacral cortex. Try to preserve the sacral bone for re-packing the implant. (Fig. 6) NOTE: Once the Drill reaches the SI joint, exercise caution advancing into the sacrum. NOTE: Utilize the correct side of the Steinmann Pin Depth Gage/Guide; it is indicated for #2 and #3 Tissue Shields. NOTE: Once the Drill bit has reached the desired depth as indicated by the markings on the shaft, place the Exchange Pin down the cannulated portion of the driver until it reaches the proximal tip of the Steinmann Pin. Slowly remove the Drill bit while keeping pressure on the Exchange Pin to ensure the Steinmann Pin remains in place. Instruments Steinmann Pin Depth Gage/Guide 07.02212.001 (X079-0084) Drill, Cannulated 07.02212.012 7.5mm (X079-0034) 07.02212.024 12.5mm (X079-0063) Ratcheting T-Handle 07.02212.031 (N60000472) Jacobs Chuck Adaptor 07.02212.032 (N60001630) Tissue Shields 07.02212.017 #2 (X079-0106) 07.02212.018 #3 (X079-0107) Exchange Pin 07.02212.028 (X079-0089) TriCor Sacroiliac Joint Fusion System – Surgical Technique 11 Tap Assembly Tap Decortication and Sacroiliac Joint Visualization Fig. 7 S Fig. 8 S Fig. 9 S Step 7 Step 8 Step 9 Attach the Tap to the Ratcheting T-Handle (Fig. 7) Place the Tap over the Steinmann Pin, slowly advancing until you reach the ilium. Make sure the Tap is co-linear with the pin to avoid binding on the pin. Take the Right Angle Curette and follow along the Steinmann Pin down to the SI joint. Once a tactile feel has been achieved, confirm in the Outlet View to verify placement in the joint. Rotate the instrument to prepare the SI joint space for bony arthrodesis. Remove the instrument once the site has been properly prepared. (Fig. 9) NOTE: Do not tap under power. Using the Outlet view, confirm placement. Under fluoroscopic guidance continue to advance the Tap across the sacroiliac joint, through to the sacral cortex. Try to preserve sacral bone for re-packing into the implant. (Fig. 8) NOTE: Once the Tap reaches the SI joint exercise caution advancing into the Sacrum. NOTE: Once the Tap has reached the desired depth as indicated by the markings on the shaft, place the Exchange Pin down the cannulated portion of the driver until it reaches the proximal tip of the Steinmann Pin. Slowly remove the Tap while keeping pressure on the Exchange Pin to ensure the Steinmann Pin remains in place. Instruments Right Angle Curette 07.02212.020 (X079-0053) Tap, Cannulated 07.02212.013 7mm (X079-0035) 07.02212.025 12.5mm (X079-0064) NOTE: A standard 2mm scope may be used through the #3 Tissue Shield for additional SI joint visualization. 12 TriCor Sacroiliac Joint Fusion System – Surgical Technique Bone Graft Pre-Pack (12.5mm Implant Only) Fig. 10 S Fig. 11 S Step 10 Step 11 Use the Graft Packing Block to pre-pack selected implant with preferred bone grafting choice. Place the distal tip of the implant on the block and insert the bone graft into the implant through the proximal end. (Fig. 10) Select the Implant Screwdriver and place onto the Ratcheting T-Handle. Select the corresponding implant and place onto the distal tip of the driver, making sure the implant is fully seated with the driver shaft. Insert the distal end of the implant over the Steinmann Pin and advance the implant, under fluoroscopy, to desired depth. (Fig. 11) CAUTION: Do not over pack as implant will obtain patient autograft during implantation. TriCor System Bone Graft Volumes (Approximate) 12.5mm implants LENGTH VOLUME 30mm 1.50cc 35mm 1.70cc 40mm 2.00cc 45mm 2.20cc 50mm 2.50cc 55mm 2.70cc 60mm 3.10cc 65mm 3.30cc 70mm 3.50cc Instruments 12.5mm Graft Packing Block 07.02212.003 (X079-0067) 12.5mm Implant Screwdriver 07.02212.023 (X079-0060) TriCor Sacroiliac Joint Fusion System – Surgical Technique 13 Implant Loading and Final Placement Fig. 12a S Fig. 12b S Fig. 12c S Step 12 Outlet View Implant progression. (Fig. 12b) Outlet View Implant progression. Fully seated. (Fig. 12c) Outlet View Implant progression. Initial placement. (Fig. 12a) Instruments 14 TriCor Sacroiliac Joint Fusion System – Surgical Technique Steinmann Pin Depth Gage Bone Graft Post Fill (12.5mm Implant Only) Fig. 13 S Fig. 14 S Step 13 Step 14 Using the first Steinmann Pin, insert the fixed portion of the Steinmann Pin Depth Gage/ Guide over the already inserted pin. Under fluoroscopy in the Lateral View, insert the second pin following the curve of the sacrum. Confirm in the three views (Lateral, Inlet, Outlet) that the second Steinmann Pin placement is accurate. Repeat steps above for implant insertion of the subsequent implants. (Fig. 13) After the Second Steinmann Pin placement is confirmed, insert the Bone Graft Funnel over the Steinmann Pin from the first implant. Rotate the funnel until fully engaged with the implant. Remove the Steinmann Pin from the first implant once the Bone Graft Funnel is in place. Next, insert the preferred bone graft through the Bone Graft Funnel, following with the Graft Tamp until fully seated with the implant. (Fig. 14) Instruments Steinmann Pin Depth Gage/ Guide 07.02212.001 (X079-0084) Trocar Steinmann Pin 07.02212.021 (X079-0054) 12.5mm Graft Funnel 07.02212.029 (X079-0080) Graft Tamp 07.02212.002 (X079-0048) TriCor Sacroiliac Joint Fusion System – Surgical Technique 15 Second Implant Targeting Fig. 15a S Fig. 15b S Fig. 15c S Step 15 Inlet View (Fig. 15b) Outlet View (Fig. 15c) Repeat Step 3 for placement of the second Trocar Steinmann Pin. Lateral View (Fig. 15a) Instruments 16 TriCor Sacroiliac Joint Fusion System – Surgical Technique Second Implant Insertion Fig. 16a S Fig. 16b S Fig. 16c S Step 16 Inlet View (Fig. 16b) Outlet View (Fig. 16c) Repeat Steps 4-14. Lateral View (Fig. 16a) Instruments TriCor Sacroiliac Joint Fusion System – Surgical Technique 17 Third Implant Targeting Fig. 17a S Fig. 17b S Fig. 17c S Step 17 Inlet View (Fig. 17b) Outlet View (Fig. 17c) Repeat Step 3 for targeting of the third implant. Lateral View (Fig. 17a) Instruments 18 TriCor Sacroiliac Joint Fusion System – Surgical Technique Third Implant Insertion Fig. 18a S Fig. 18b S Fig. 18c S Step 18 Inlet View (Fig. 18b) Outlet View (Fig. 18c) Repeat Steps 4-14. Lateral View (Fig. 18a) Instruments TriCor Sacroiliac Joint Fusion System – Surgical Technique 19 Final Implant Construct Fig. 19a S Fig. 19b S Fig. 19c S Step 19 Inlet View (Fig. 19b) Outlet View (Fig. 19c) Confirm final implant placement using Lateral, Inlet and Outlet views under fluoroscopy. Lateral View (Fig. 19a) Instruments 20 TriCor Sacroiliac Joint Fusion System – Surgical Technique Tissue Shield Skin Marking Skin Incision Surgical Technique 1 2 Fig. 20 S Step 1 Step 2 Use the Exchange Pin to mark the Posterior Sacral Wall (PSW, #1) and Sacral Alar Line (#2) with a marking pen. (Fig. 20) Make a skin incision along the Posterior Sacral Wall, approximately 3-5cm in length, starting at intersection with sacral ala skin marking. Beginning in the Lateral View, insert the Trocar Steinmann Pin through skin incision approximately 1cm anterior to the Posterior Sacral Wall and 1cm inferior to the ala. (Fig. 20) Instruments Exchange Pin 07.02212.028 (X079-0089) TriCor Sacroiliac Joint Fusion System – Surgical Technique 21 Steinmann Pin Placement Fig. 21a S Fig. 21b S Fig. 21c S Step 3 Inlet View - The angle of Steinmann Pin should be heading towards the middle of the sacrum. (Fig. 21b) Outlet View - The Steinmann Pin should be parallel to the S1 endplate. Mallet the Steinmann Pin in final desired depth in Outlet view. (Fig. 21c) Confirm placement in 3 views: Lateral View - Place Steinmann Pin approximately 1cm anterior to PSW and 1cm inferior to ala. (Fig. 21a) NOTE: Blunt or Threaded Steinmann Pins are available to replace the Trocar Steinmann Pin after placement, if desired. NOTE: Use the #1 Tissue Shield to stabilize the Trocar Steinmann Pin for impaction. Instruments Steinmann Pins 07.02212.021 Trocar (X079-0054) 07.02212.022 Threaded (X079-0057) 07.02212.027 Blunt (X079-0086) Mallet 07.02212.019 (X034-0915) #1 Tissue Shield 07.02212.016 (X079-0045) 22 TriCor Sacroiliac Joint Fusion System – Surgical Technique Tissue Shield Placement Measuring/Implant Selection Fig. 22 S Fig. 23 S Step 4 Step 5 Drop #1, 2 and 3 Tissue Shields, in sequence, over the Steinmann Pin. Once the #3 Tissue Shield is in place, remove the #1-2 Tissue Shields. (Fig. 22) While keeping the Tissue Shield in place, use the Steinmann Pin Depth Gage/Guide to select appropriate implant. Insert the Steinmann Pin Depth Gage underneath the inserted Steinmann Pin and dock onto the proximal end of the Tissue Shield. Measure with #3 Tissue Shield for 12.5mm implants and measure with #2 Tissue Shield for 7mm implants. (Fig. 23) NOTE: Optional Tissue Shield Guide Handle may be used for added stability. NOTE: Utilize the correct side of the Steinmann Pin Depth Gage/Guide; it is indicated for #2 and #3 Tissue Shields. Instruments Tissue Shields 07.02212.016 #1 (X079-0045) 07.02212.017 #2 (X079-0106) 07.02212.018 #3 (X079-0107) Tissue Shield Guide Handle 07.02212.030 (X079-0090) Steinmann Pin Depth Gage/ Guide 07.02212.001 (X079-0084) TriCor Sacroiliac Joint Fusion System – Surgical Technique 23 Drill Assembly Drill Tap Assembly Fig. 24 S Fig. 25 S Fig. 26 S Step 6 Step 7 Step 8 Attach the Drill bit to the Ratcheting T-Handle or cordless power drill using the provided Jacobs Chuck.(Fig. 24) Place the Drill bit over the Steinmann Pin slowly advancing until the ilium is reached. Make sure that the Drill is co-linear with the Pin to avoid binding on the Pin. Attach the Tap to the Ratcheting T-Handle. (Fig. 26) NOTE: Make sure the flat portion of the provided Jacobs Chuck attachment fits flush to the walls if using the cordless power drill. NOTE: The drill flutes are designed to capture the autogenous bone graft for reuse in the 12.5mm anchor implant. CAUTION: Do not tap under power. Using the Outlet view, confirm accurate placement of the Drill bit over the Steinmann Pin. Under fluoroscopic guidance, continue to advance the Drill just across the sacroiliac joint, through the sacral cortex. Try to preserve sacral bone for re-packing the implant. (Fig. 25) NOTE: Once the Drill reaches the SI joint, exercise caution advancing into the sacrum. NOTE: Once the Drill bit has reached the desired depth as indicated by the markings on the shaft, place the Exchange Pin down the cannulated portion of the driver until it reaches the proximal tip of the Steinmann Pin. Slowly remove the Drill bit while keeping pressure on the Exchange Pin to ensure that the Steinmann Pin remains in place. Instruments Drill 07.02212.012 7mm (X079-0034) 07.02212.024 12.5mm (X079-0063) Ratcheting T-Handle 07.02212.031 (N60000472) Jacobs Chuck Adaptor 07.02212.032 (N60001630) Exchange Pin 07.02212.028 (X079-0089) Tap, Cannulated 07.02212.013 7mm (X079-0035) 07.02212.025 12.5mm (X079-0064) 24 TriCor Sacroiliac Joint Fusion System – Surgical Technique Tap Decortication and Sacroiliac Joint Visualization Bone Graft Pre-Pack (12.5mm Implant only) Fig. 27 S Fig. 28 S Fig. 29 S Step 9 Step 10 Step 11 Place the Tap over Steinmann Pin, slowly advancing until you reach the ilium. Make sure that the Tap is co-linear with the pin to avoid binding on the pin. Take the Right Angle Curette and place through the #3 Tissue Shield. Once a tactile feel has been achieved, confirm in the Outlet view to verify placement in the joint. Rotate the instrument to prepare the SI joint space for bony arthrodesis. Remove the instrument once the site has been properly prepared. (Fig. 28) Use the Graft Packing Block to pre-pack selected implant with preferred bone grafting choice. Place the distal tip of the implant on the block and insert the bone graft into the implant through the proximal end. (Fig. 29) Using the Outlet view, confirm placement. Under fluoroscopic guidance continue to advance the Tap across the sacroiliac joint, through to the sacral cortex. Try to preserve sacral bone for re-packing into the implant. (Fig. 27) NOTE: Once the Tap reaches the SI joint exercise caution advancing into the sacrum. NOTE: Once the Tap has reached the desired depth as indicated by the markings on the shaft, place the Exchange Pin down the cannulated portion of the driver until it reaches the proximal tip of the Steinmann Pin. Slowly remove the Tap while keeping pressure on the Exchange Pin to ensure that the Steinmann Pin remains in place. Instruments Right Angle Curette 07.02212.020 (X079-0053) 12.5mm Graft Packing Block 07.02212.003 (X079-0067) CAUTION: Do not over pack as implant will obtain patient autograft during implantation. TriCor System Bone Graft Volumes (Approximate) NOTE: A standard 2mm scope may be used through the #3 Tissue Shield for additional SI joint visualization. 12.5mm implants LENGTH VOLUME 30mm 1.50cc 35mm 1.70cc 40mm 2.00cc 45mm 2.20cc 50mm 2.50cc 55mm 2.70cc 60mm 3.10cc 65mm 3.30cc 70mm 3.50cc TriCor Sacroiliac Joint Fusion System – Surgical Technique 25 Implant Loading and Final Placement Steinmann Pin Depth Gage Fig. 30 S Fig. 31 S Step 12 Step 13 Select the Implant Screwdriver and place onto the Ratcheting T-Handle. Select the corresponding implant and place onto the distal tip of the driver, making sure the implant is fully seated with the driver shaft. Insert the distal end of the implant over the Steinmann Pin and advance the implant, under fluoroscopy, to desired depth. (Fig. 30) Using the first Steinmann Pin, insert the Steinmann Pin Depth Gage/Guide starting in the 0˚ position over the already inserted pin. Under fluoroscopy in the Lateral view, insert the second pin at the 20˚ marker while following the curve of the sacrum. Confirm in the three views (Lateral, Inlet, Outlet) that the second Steinmann Pin placement is accurate. Repeat steps above for implant insertion of the subsequent implants. (Fig. 31) Repeat steps 13-19 on pages 14-19 using the Tissue Shield for the remaining two implants. Instruments Steinmann Pin Depth Gage/ Guide 07.02212.001 (X079-0084) Implant Screwdriver 07.02212.010 7mm (X079-0030) 07.02212.023 12.5mm (X079-0060) 26 TriCor Sacroiliac Joint Fusion System – Surgical Technique Bone Graft Post Fill (12.5mm Implant only) Fig. 32 S Step 14 Step 15 After the Second Steinmann Pin placement is confirmed, insert the Graft Funnel through the #3 Tissue Shield and over the Steinmann Pin from the first implant. Rotate the Graft Funnel until fully engaged with the implant. Remove the Steinmann Pin from the first implant once the Graft Funnel is in place. Next, insert the preferred bone graft through the Graft Funnel, following with the Graft Tamp until fully seated with the implant. (Fig. 32) Repeat steps 4-14 on pages 20-26 of the Tissue Shield Technique for the remaining two implants. Refer to pages 16-19 for images showing implant placement. Instruments 12.5mm Graft Funnel 07.02212.029 (X079-0080) Graft Tamp 07.02212.002 (X079-0048) TriCor Sacroiliac Joint Fusion System – Surgical Technique Implant Removal and Adjustment 27 Implant Removal and Adjustment Surgical Technique Fig. 33 S After the Second Steinmann Pin placement: Option #1 – 12.5mm Implant - Attach the Ratcheting T-Handle to the 12.5mm Implant Screwdriver, and locate the proximal end of the implant that needs adjusting. Fully seat the distal end of the Implant Screwdriver into the desired implant. With the Ratcheting T-Handle, rotate counterclockwise to adjust or fully remove the implant. (Fig. 33) Option #2 – 12.5mm Implant - Using palpation and fluoroscopy, locate the proximal end of the implant that needs adjusting. Insert the distal end of the 12.5mm Implant Removal Instrument into the desired implant until the initial fenestration is reached. Rotate the implant removal tool counter-clockwise or pull axially to adjust or fully remove the implant. NOTE: The knob at the proximal end of the 12.5mm Implant Removal Tool must be pulled proximally during insertion into the implant. Next, upon finding the fenestration, the knob is pushed forward and locked to retain the implant. 7mm Anchor Implant - Attach the Ratcheting T-Handle to the 7mm Adjustment Screwdriver, and, locate the proximal end of the implant that needs adjusting. Fully seat the distal end of the Implant Screwdriver into the desired implant. With the Ratcheting T-Handle, rotate counterclockwise to adjust or fully remove the implant. Instruments 12.5mm Implant Screwdriver 07.02212.010 (X079-0030) 7mm Adjustment Screwdriver 07.02212.011 (X079-0033) Ratcheting T-Handle 07.02212.031 (N60000472) 12.5mm Implant Removal Instrument 07.02212.033 (X079-0099) 28 TriCor Sacroiliac Joint Fusion System – Surgical Technique Instrument Visual Guide Ratcheting T-Handle 07.02212.031 (N60000472) Jacobs Chuck Adaptor 07.02212.032 (N60001630) #1 Tissue Shield, Stainless Steel, 9mm 07.02212.016 (X079-0045) #2 Tissue Shield, Stainless Steel, 13mm 07.02212.017 (X079-0106) #3 Tissue Shield, Stainless Steel, 16mm 07.02212.018 (X079-0107) Tissue Shield Guide Handle 07.02212.030 (X079-0090) Implant Screwdrivers, Cannulated 07.02212.010 7mm (X079-0030) 07.02212.023 12.5mm (X079-0060) Drills, Cannulated 07.02212.012 7mm (X079-0034) 07.02212.024 12.5mm (X079-0063) Taps, Cannulated 07.02212.013 7mm (X079-0035) 07.02212.025 12.5mm (X079-0064) Bone Awl, Cannulated 07.02212.014 (X079-0042) 12.5mm Graft Packing Block 07.02212.003 (X079-0067) Mallet 07.02212.019 (X034-0915) TriCor Sacroiliac Joint Fusion System – Surgical Technique 29 12.5mm Graft Funnel 07.02212.029 (X079-0080) Graft Tamp 07.02212.002 (X079-0048 ) Steinmann Pin Depth Gage/Guide 07.02212.001 (X079-0084) Right Angle Curette 07.02212.020 (X079-0053) 12.5mm Implant Removal Instrument 07.02212.033 (X079-0099) 7mm Adjustment Screwdriver 07.02212.011 (X079-0033) Cannula Cleaner 07.02212.015 (X079-0043) Steinmann Pin 07.02212.021 Trocar (X079-0054) 07.02212.022 Threaded (X079-0057) 07.02212.027 Blunt (X079-0086 Exchange Pin 07.02212.028 (X079-0089) 30 TriCor Sacroiliac Joint Fusion System – Surgical Technique Tray Layouts TriCor Sacroiliac Joint Fusion Instrument and Implant System 07.02211.400 Implants Part Number Description Quantity 07.02211.001 Cannulated Screw, Dual Thread, Ø7mm x 30mm 2 07.02211.002 Cannulated Screw, Dual Thread, Ø7mm x 35mm 4 07.02211.003 Cannulated Screw, Dual Thread, Ø7mm x 40mm 4 07.02211.004 Cannulated Screw, Dual Thread, Ø7mm x 45mm 4 07.02211.005 Cannulated Screw, Dual Thread, Ø7mm x 50mm 4 07.02211.006 Cannulated Screw, Dual Thread, Ø7mm x 55mm 2 07.02211.007 Cannulated Screw, Dual Thread, Ø7mm x 60mm 4 07.02211.008 Cannulated Screw, Dual Thread, Ø7mm x 65mm 2 07.02211.009 Cannulated Screw, Dual Thread, Ø7mm x 70mm 2 07.02211.010 Washer, 13mm 4 07.02211.011 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 30mm 2 07.02211.012 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 35mm 2 07.02211.013 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 40mm 3 07.02211.014 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 45mm 3 07.02211.015 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 50mm 3 07.02211.016 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 55mm 3 07.02211.017 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 60mm 3 07.02211.018 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 65mm 2 07.02211.019 Cannulated Screw, Dual Thread, Plasma Coated, Ø12.5mm x 70mm 2 Instruments Quantity Part Number 07.02212.001 Part Number Steinmann Pin Depth Gage/Guide Description 1 07.02212.017 #2 Tissue Shield, Stainless Steel, 13mm Description Quantity 1 07.02212.002 Graft Tamp 1 07.02212.018 #3 Tissue Shield, Stainless Steel, 16mm 1 07.02212.003 Graft Packing Block, 12.5mm 1 07.02212.019 Mallet 1 07.02212.004 Sterilization Case 1 07.02212.020 Right Angle Curette 1 07.02212.007 Steinmann Pin Holder (Trocar) 1 07.02212.023 Ø12.5mm Implant Screwdriver, Cannulated 2 07.02212.008 Steinmann Pin Holder (Threaded) 1 07.02212.024 Ø12.5mm Drill, Cannulated 2 07.02212.009 Instructions for Use 1 07.02212.025 Ø12.5mm Tap, Cannulated 1 07.02212.010 Ø7mm Implant Screwdriver, Cannulated 2 07.02212.026 Steinmann Pin Holder (Blunt) 1 07.02212.011 Ø7mm Adjustment Screwdriver, Cannulated 1 07.02212.029 Ø12.5mm Graft Funnel 1 07.02212.012 Ø7mm Drill, Cannulated 2 07.02212.030 Tissue Shield Guide Handle 2 07.02212.013 Ø7mm Tap, Cannulated 1 07.02212.031 Ratcheting T-Handle, 1/4" Drive 1 07.02212.014 Bone Awl, Cannulated 1 07.02212.032 Jacobs Chuck Adaptor, 1/4" Square 1 07.02212.015 350mm Stylet (.090"), Cannula Cleaner 1 07.02212.033 Ø12.5mm Implant Removal Instrument 1 07.02212.016 #1 Tissue Shield, Stainless Steel, 9mm 1 Single Use Instruments Part Number Description Quantity 07.02212.021 Ø2.4mm x 300mm (.094") Steinmann Pin (Trocar) 5 07.02212.022 Ø2.4mm x 300mm (.094") Steinmann Pin (Threaded) 5 07.02212.027 Ø2.4mm x 300mm (.094") Steinmann Pin (Blunt) 5 07.02212.028 500mm Exchange Pin 2 TriCor Sacroiliac Joint Fusion System – Surgical Technique 31 Warnings and Precautions WARNINGS As with any surgical system, the TriCor Sacroiliac Joint Fusion system should be used by experienced surgeons with specific training in the use of the spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. Knowledge of surgical techniques, proper reduction, selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome. Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanics and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life. (Note: While proper implant selection can minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of the implants). Patients who smoke have been shown to have an increased incidence of pseudoarthrosis. Such patients should be advised of this fact and warned of the potential consequences. Patients with previous spinal surgery at the level to be treated may have different clinical outcomes compared to those without a previous surgery. Based on the fatigue testing results, the physician/surgeon should consider the level of implantation, patient weight, patient activity level, and other patient conditions, etc. which may have an impact on the performance of the system. If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) resultant forces can cause failure of the device. In some cases, progression of degenerative disease may be so advanced at the time of implantation that the expected useful life of the appliance may be substantially decreased. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief. Patients should be instructed in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will bend, loosen or fracture if excessive demands are placed on it. An active, debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation. Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. As with all orthopedic and neurosurgical implants, none of the TriCor Sacroiliac Joint Fusion System components should ever be reused under any circumstances. Risks associated with reuse include infection, nonunion (pseudarthrosis), serious patient injury or death. Due to the presence of implants, interference with roentgenographic, CT and/or MR imaging may result. The TriCor Sacroiliac Joint Fusion System has not been evaluated for safety and compatibility in the MR environment. The TriCor Sacroiliac Joint Fusion System has not been tested for heating or migration in the MR environment. It must be noted that there are several different manufacturers and generations of MRI systems available, and Zimmer Spine cannot make any claims regarding the safety of Zimmer Spine implants and devices with any specific MR system. Physician Note: The physician is the learned intermediary between the company and the patient. The indications, contraindications, warnings, and precautions given in this document must be conveyed to the patient. Disclaimer: This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, indications, contraindications, warnings, precautions, and adverse effects. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects. Printed in U.S.A. Subject to change without notice. Contact your Zimmer Spine representative or visit us at www.zimmerspine.com Manufactured by: X-spine Systems, Inc. 452 Alexandersville Road Miamisburg, OH 45342 800.903.0640 Distributed by: EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570 Fax: +31.70.346.7299 Zimmer Spine 7375 Bush Lake Road Minneapolis, MN 55439 800.655.2614 zimmerspine.com L1641 Rev. A (2014-07) (851S-1001-00) © 2014 Zimmer Spine, Inc.
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.5 Linearized : Yes Author : pinos Create Date : 2014:07:09 19:33:47-05:00 Modify Date : 2014:07:09 19:33:47-05:00 XMP Toolkit : Adobe XMP Core 4.2.1-c043 52.372728, 2009/01/18-15:08:04 Metadata Date : 2014:07:09 19:32:56-05:00 Creator Tool : Adobe InDesign CS6 (Windows) Instance ID : uuid:fe951fff-2cdf-437a-8074-d20525ffa8e6 Original Document ID : xmp.did:5ABE86B76292E211A823F4DABF6AB6F4 Document ID : xmp.id:AC1AEB8AC807E411A646F8C23E6BDB1A Rendition Class : proof:pdf Derived From Instance ID : xmp.iid:AA1AEB8AC807E411A646F8C23E6BDB1A Derived From Document ID : xmp.did:4ECB6EA867FDE311A60F915B20C58488 Derived From Original Document ID: xmp.did:5ABE86B76292E211A823F4DABF6AB6F4 Derived From Rendition Class : default History Action : converted History Parameters : from application/x-indesign to application/pdf History Software Agent : Adobe InDesign CS6 (Windows) History Changed : / History When : 2014:07:09 19:29:09-05:00 Format : application/pdf Title : L1641_A TriCor Surg Tech.pdf Creator : pinos Producer : Acrobat Distiller 9.5.5 (Windows) Trapped : False Page Count : 32EXIF Metadata provided by EXIF.tools