Bone Tendon Bone TransFix® II ACL Reconstruction

Report 3 Downloads 39 Views
Ordering Information: TransFix II ACL Reconstruction Set (AR-1817TS)

Surgical Technique

BTB TransFix Implants & Disposables (single use & sterile):

Bone Tendon Bio-TransFix, 3 mm x 40 mm AR-135IBT Bone Tendon Bio-TransFix, 3 mm x 50 mm AR-1351LBT TransFix II Drill Set AR-1978S

TransFix Implants & Disposables: Actual size of Bone Tendon Bio-TransFix Implant

Bio-TransFix Implant, 5 mm x 40 mm Bio-TransFix Implant, 5 mm x 50 mm (b) Bio-TransFix Implant, 5 mm x 60 mm Bone Tendon Bio-TransFix, 3 mm x 40 mm Bone Tendon Bio-TransFix, 3 mm x 50 mm (d) TransFix Implant, 3 mm x 40 mm, titanium (c) TransFix Implant, 3 mm x 50 mm, titanium TransFix Screw, 3 mm x 40 mm, titanium (a) TransFix Screw, 3 mm x 50 mm, titanium

Disposables:

TransFix Disposables Kit, sterile BTB TransFix II Pin and Graft Passing Wire Set Metal TransFix Convenience Pack, 40 mm Metal TransFix Convenience Pack, 50 mm Bio-TransFix Convenience Pack, 40 mm Bio-TransFix Convenience Pack, 50 mm

Delta Screw Tibial Fixation Instrumentation: Ratcheting Screwdriver Handle Cannulated Short Screwdriver Shaft for Bio-Interference Screws Torque Measurement Device

Actual size of 7 mm x 28 mm Full Thread Bio-Interference Screw

Tibial Fixation Implants:

Full Thread Bio-Interference Screw, 7 mm x 28 mm Full Thread Bio-Interference Screw, 8 mm x 28 mm Full Thread Bio-Interference Screw, 9 mm x 28 mm Full Thread Bio-Interference Screw, 10 mm x 28 mm Full Thread Bio-Interference Screw, 11 mm x 28 mm Full Thread Bio-Interference Screw, 12 mm x 28 mm

AR-1351B AR-1351LB AR-1351XLB AR-1351BT AR-1351LBT AR-1351 AR-1351L AR-1363 AR-1363L AR-1978S AR-1971S AR-1351K-CP AR-1351LK-CP AR-1351BK-CP AR-1351BLK-CP AR-1999 AR-1997SH AR-1990 AR-1370TB AR-1380TB AR-1390TB AR-1400TB AR-1403TB AR-1404TB

Femoral and Tibial Tunnel Placement Instrumentation: ACL Cruciate Reconstruction ToolBox Set Transtibial ACL Reconstruction Set

Recommended Graft Prep Suture: #2 FiberLoop w/Straight Needle #2 TigerLoop w/Straight Needle

Passing Suture: #2 TigerWire

AR-1900S AR-1817AS AR-7234 AR-7234T AR-7203

This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s Directions For Use.

Actual size of metal TransFix Implant

U.S. PATENT NOS. 5,895,425; 5,918,604; 6,132,433; 6,371,124; 6,537,319; 6,544,281; 6,623,524; 6,629,977; 6,733,529; 6,875,216; 6,974,477; 7,066,956; 7,077,863; 7,306,626 and PATENTS PENDING

© 2011, Arthrex Inc. All rights reserved. LT0125D

BTB TransFix ACL Reconstruction

Bone Tendon Bone Bio-TransFix® II ACL Reconstruction

Surgical Technique Bone Tendon Bone Bio-TransFix II ACL Reconstruction mm 10

Graft Preparation Shape the proximal and distal ends of the graft to the appropriate diameter. The proximal end should have at least a 30 mm length, matching the femoral socket length. Confirm the size of the graft using the Graft Sizing Block.

a

(Note: it is not recommended to use any bone dowel smaller than 9 mm in diameter.) Position the proximal bone dowel of the graft so that the cortical bone component is facing up. For a BTB or Achilles tendon graft, use a 3 mm drill to create a hole 10 mm from the proximal end of the proximal bone dowel. Be sure to center the drill onto the cortical bone component of the graft.

4 1 The tibial tunnel guide pin is anatomically positioned by referencing a point 7 mm anterior of the PCL base with the PCL referencing tibial guide marking hook. The tibial tunnel length of at least 40 mm can be determined prior to guide pin placement with the calibrated guide sleeve. The tibial tunnel is drilled to a diameter 1 to 2 mm less than the graft diameter and dilators impacted to create the final tunnel diameter equal to the graft diameter.

5

b

The Nitinol Graft Passing Wire is hooked into the 3 mm guide pin slot. The Guide Pin is pulled medially drawing the Nitinol wire through the 3 mm pilot hole and the TransFix II Tunnel Hook. The Tunnel Hook is extracted, pulling the Graft Passing Wire out of the tibial tunnel (a).

Exposure of the guide sleeve’s marking (a) external to the guide housing indicates the need for a 50 mm Bio-TransFix Implant. The 3 mm Drill Pin is drilled through the guide sleeve and the tunnel hook, exiting the femur medially. The 5 mm broach (b), with depth stop collar, is drilled over the 3 mm guide pin to broach the cortex for the Bio-TransFix Implant. The depth of the soft tissue is measured with the graduations on the drill shaft and used as a secondary control of subsequent implant insertion depth.

a

8 As the proximal bone dowel is pulled into the joint (before pulled into the femoral socket) slight tension should be applied to the graft distally to insure proper graft orientation. Continue to pull the graft up into the femoral socket. After graft passage, unrestricted back and forth motion of the graft passing wire confirms accurate insertion of the graft.

9 The 40, 50 or 60 mm implant is hand-inserted over the Nitinol wire. The appropriate driver is inserted over the wire until the implant is engaged. The wire should be secured with a needle holder at the handle exit. With combined impaction and medial pulling of the wire, the implant is inserted until the driver flange, aligned anteriorly, contacts the cortical bone surface. Depth markings on the driver should match the prior broach depth mark to secondarily confirm proper implant insertion depth.

a

2 The femoral tunnel is created by referencing the over-the-top position with a Transtibial Femoral ACL Drill Guide (TTG) to create a 1 to 2 mm or less tunnel backwall. A 2.4 mm Drill Tip Guide Pin is positioned with the TTG and a Cannulated Headed Reamer equal to the graft diameter is drilled to a depth of 30 mm. The drill and guide pin are removed.

3 The TransFix II Tunnel Hook that matches the tunnel diameter is assembled with the TransFix II Drill Guide. The tunnel hook is inserted through the tibial tunnel and positioned into the femoral socket. The Guide Pin Sleeve is positioned on the skin of the lateral thigh, a small incision is made and the sleeve advanced to bone.

6 Pass the end of a #2 FiberWire suture into the loop of the TransFix wire positioned outside the medial knee (a). Shuttle the suture out of the tibial tunnel by pulling on the TransFix wire distally. Remove the suture from the loop and thread the wire through the hole in the graft (cortical side first). Reconnect the suture to the wire by tying the end of the FiberWire around the suture loop (b). Advance the suture up and out of the medial knee so the connection is now outside the knee.

b

7 Cut the suture off of the TransFix wire. Simultaneously pull the wire ends of the looped wire away from the knee to advance the graft up through the tibial tunnel.

10 Secure tibial fixation is obtained with a 28 mm Full Thread BioInterference Screw. A tunnel notcher should be used to create a superior notch in the rim to ease screw insertion. The screw may be inserted with the Torque Measurement Device to quantify insertion torque and subsequent fixation strength.

Note: Proper technique must be followed to ensure adequate tunnel/socket and aperture preparation. Deviating from the technique may cause excessive torque on the screw during implantation and lead to damage to the graft or damage to the implant. It is also recommended to monitor the implantation depth of the screw to ensure that the tip of the screw inserted into the tibial tunnel is not protruding into joint.

Surgical Technique Bone Tendon Bone Bio-TransFix II ACL Reconstruction mm 10

Graft Preparation Shape the proximal and distal ends of the graft to the appropriate diameter. The proximal end should have at least a 30 mm length, matching the femoral socket length. Confirm the size of the graft using the Graft Sizing Block.

a

(Note: it is not recommended to use any bone dowel smaller than 9 mm in diameter.) Position the proximal bone dowel of the graft so that the cortical bone component is facing up. For a BTB or Achilles tendon graft, use a 3 mm drill to create a hole 10 mm from the proximal end of the proximal bone dowel. Be sure to center the drill onto the cortical bone component of the graft.

4 1 The tibial tunnel guide pin is anatomically positioned by referencing a point 7 mm anterior of the PCL base with the PCL referencing tibial guide marking hook. The tibial tunnel length of at least 40 mm can be determined prior to guide pin placement with the calibrated guide sleeve. The tibial tunnel is drilled to a diameter 1 to 2 mm less than the graft diameter and dilators impacted to create the final tunnel diameter equal to the graft diameter.

5

b

The Nitinol Graft Passing Wire is hooked into the 3 mm guide pin slot. The Guide Pin is pulled medially drawing the Nitinol wire through the 3 mm pilot hole and the TransFix II Tunnel Hook. The Tunnel Hook is extracted, pulling the Graft Passing Wire out of the tibial tunnel (a).

Exposure of the guide sleeve’s marking (a) external to the guide housing indicates the need for a 50 mm Bio-TransFix Implant. The 3 mm Drill Pin is drilled through the guide sleeve and the tunnel hook, exiting the femur medially. The 5 mm broach (b), with depth stop collar, is drilled over the 3 mm guide pin to broach the cortex for the Bio-TransFix Implant. The depth of the soft tissue is measured with the graduations on the drill shaft and used as a secondary control of subsequent implant insertion depth.

a

8 As the proximal bone dowel is pulled into the joint (before pulled into the femoral socket) slight tension should be applied to the graft distally to insure proper graft orientation. Continue to pull the graft up into the femoral socket. After graft passage, unrestricted back and forth motion of the graft passing wire confirms accurate insertion of the graft.

9 The 40 or 50 mm implant is hand-inserted over the Nitinol wire. The appropriate driver is inserted over the wire until the implant is engaged. The wire should be secured with a needle holder at the handle exit. With combined impaction and medial pulling of the wire, the implant is inserted until the driver flange, aligned anteriorly, contacts the cortical bone surface. Depth markings on the driver should match the prior broach depth mark to secondarily confirm proper implant insertion depth.

a

2 The femoral tunnel is created by referencing the over-the-top position with a Transtibial Femoral ACL Drill Guide (TTG) to create a 1 to 2 mm or less tunnel backwall. A 2.4 mm Drill Tip Guide Pin is positioned with the TTG and a Cannulated Headed Reamer equal to the graft diameter is drilled to a depth of 30 mm. The drill and guide pin are removed.

3 The TransFix II Tunnel Hook that matches the tunnel diameter is assembled with the TransFix II Drill Guide. The tunnel hook is inserted through the tibial tunnel and positioned into the femoral socket. The Guide Pin Sleeve is positioned on the skin of the lateral thigh, a small incision is made and the sleeve advanced to bone.

6 Pass the end of a #2 FiberWire suture into the loop of the TransFix wire positioned outside the medial knee (a). Shuttle the suture out of the tibial tunnel by pulling on the TransFix wire distally. Remove the suture from the loop and thread the wire through the hole in the graft (cortical side first). Reconnect the suture to the wire by tying the end of the FiberWire around the suture loop (b). Advance the suture up and out of the medial knee so the connection is now outside the knee.

b

7 Cut the suture off of the TransFix wire. Simultaneously pull the wire ends of the looped wire away from the knee to advance the graft up through the tibial tunnel.

10 Secure tibial fixation is obtained with a 28 mm Full Thread BioInterference Screw. A tunnel notcher should be used to create a superior notch in the rim to ease screw insertion. The screw may be inserted with the Torque Measurement Device to quantify insertion torque and subsequent fixation strength.

Note: Proper technique must be followed to ensure adequate tunnel/socket and aperture preparation. Deviating from the technique may cause excessive torque on the screw during implantation and lead to damage to the graft or damage to the implant. It is also recommended to monitor the implantation depth of the screw to ensure that the tip of the screw inserted into the tibial tunnel is not protruding into joint.

Surgical Technique Bone Tendon Bone Bio-TransFix II ACL Reconstruction mm 10

Graft Preparation Shape the proximal and distal ends of the graft to the appropriate diameter. The proximal end should have at least a 30 mm length, matching the femoral socket length. Confirm the size of the graft using the Graft Sizing Block.

a

(Note: it is not recommended to use any bone dowel smaller than 9 mm in diameter.) Position the proximal bone dowel of the graft so that the cortical bone component is facing up. For a BTB or Achilles tendon graft, use a 3 mm drill to create a hole 10 mm from the proximal end of the proximal bone dowel. Be sure to center the drill onto the cortical bone component of the graft.

4 1 The tibial tunnel guide pin is anatomically positioned by referencing a point 7 mm anterior of the PCL base with the PCL referencing tibial guide marking hook. The tibial tunnel length of at least 40 mm can be determined prior to guide pin placement with the calibrated guide sleeve. The tibial tunnel is drilled to a diameter 1 to 2 mm less than the graft diameter and dilators impacted to create the final tunnel diameter equal to the graft diameter.

5

b

The Nitinol Graft Passing Wire is hooked into the 3 mm guide pin slot. The Guide Pin is pulled medially drawing the Nitinol wire through the 3 mm pilot hole and the TransFix II Tunnel Hook. The Tunnel Hook is extracted, pulling the Graft Passing Wire out of the tibial tunnel (a).

Exposure of the guide sleeve’s marking (a) external to the guide housing indicates the need for a 50 mm Bio-TransFix Implant. The 3 mm Drill Pin is drilled through the guide sleeve and the tunnel hook, exiting the femur medially. The 5 mm broach (b), with depth stop collar, is drilled over the 3 mm guide pin to broach the cortex for the Bio-TransFix Implant. The depth of the soft tissue is measured with the graduations on the drill shaft and used as a secondary control of subsequent implant insertion depth.

a

8 As the proximal bone dowel is pulled into the joint (before pulled into the femoral socket) slight tension should be applied to the graft distally to insure proper graft orientation. Continue to pull the graft up into the femoral socket. After graft passage, unrestricted back and forth motion of the graft passing wire confirms accurate insertion of the graft.

9 The 40, 50 or 60 mm implant is hand-inserted over the Nitinol wire. The appropriate driver is inserted over the wire until the implant is engaged. The wire should be secured with a needle holder at the handle exit. With combined impaction and medial pulling of the wire, the implant is inserted until the driver flange, aligned anteriorly, contacts the cortical bone surface. Depth markings on the driver should match the prior broach depth mark to secondarily confirm proper implant insertion depth.

a

2 The femoral tunnel is created by referencing the over-the-top position with a Transtibial Femoral ACL Drill Guide (TTG) to create a 1 to 2 mm or less tunnel backwall. A 2.4 mm Drill Tip Guide Pin is positioned with the TTG and a Cannulated Headed Reamer equal to the graft diameter is drilled to a depth of 30 mm. The drill and guide pin are removed.

3 The TransFix II Tunnel Hook that matches the tunnel diameter is assembled with the TransFix II Drill Guide. The tunnel hook is inserted through the tibial tunnel and positioned into the femoral socket. The Guide Pin Sleeve is positioned on the skin of the lateral thigh, a small incision is made and the sleeve advanced to bone.

6 Pass the end of a #2 FiberWire suture into the loop of the TransFix wire positioned outside the medial knee (a). Shuttle the suture out of the tibial tunnel by pulling on the TransFix wire distally. Remove the suture from the loop and thread the wire through the hole in the graft (cortical side first). Reconnect the suture to the wire by tying the end of the FiberWire around the suture loop (b). Advance the suture up and out of the medial knee so the connection is now outside the knee.

b

7 Cut the suture off of the TransFix wire. Simultaneously pull the wire ends of the looped wire away from the knee to advance the graft up through the tibial tunnel.

10 Secure tibial fixation is obtained with a 28 mm Full Thread BioInterference Screw. A tunnel notcher should be used to create a superior notch in the rim to ease screw insertion. The screw may be inserted with the Torque Measurement Device to quantify insertion torque and subsequent fixation strength.

Note: Proper technique must be followed to ensure adequate tunnel/socket and aperture preparation. Deviating from the technique may cause excessive torque on the screw during implantation and lead to damage to the graft or damage to the implant. It is also recommended to monitor the implantation depth of the screw to ensure that the tip of the screw inserted into the tibial tunnel is not protruding into joint.

Ordering Information: TransFix II ACL Reconstruction Set (AR-1817TS)

Surgical Technique

BTB TransFix Implants & Disposables (single use & sterile):

Bone Tendon Bio-TransFix, 3 mm x 40 mm AR-135IBT Bone Tendon Bio-TransFix, 3 mm x 50 mm AR-1351LBT TransFix II Drill Set AR-1978S

TransFix Implants & Disposables: Actual size of Bone Tendon Bio-TransFix Implant

Bio-TransFix Implant, 5 mm x 40 mm Bio-TransFix Implant, 5 mm x 50 mm (b) Bio-TransFix Implant, 5 mm x 60 mm Bone Tendon Bio-TransFix, 3 mm x 40 mm Bone Tendon Bio-TransFix, 3 mm x 50 mm (d) TransFix Implant, 3 mm x 40 mm, titanium (c) TransFix Implant, 3 mm x 50 mm, titanium TransFix Screw, 3 mm x 40 mm, titanium (a) TransFix Screw, 3 mm x 50 mm, titanium

Disposables:

TransFix Disposables Kit, sterile BTB TransFix II Pin and Graft Passing Wire Set Metal TransFix Convenience Pack, 40 mm Metal TransFix Convenience Pack, 50 mm Bio-TransFix Convenience Pack, 40 mm Bio-TransFix Convenience Pack, 50 mm

Delta Screw Tibial Fixation Instrumentation: Ratcheting Screwdriver Handle Cannulated Short Screwdriver Shaft for Bio-Interference Screws Torque Measurement Device

Actual size of 7 mm x 28 mm Full Thread Bio-Interference Screw

Tibial Fixation Implants:

Full Thread Bio-Interference Screw, 7 mm x 28 mm Full Thread Bio-Interference Screw, 8 mm x 28 mm Full Thread Bio-Interference Screw, 9 mm x 28 mm Full Thread Bio-Interference Screw, 10 mm x 28 mm Full Thread Bio-Interference Screw, 11 mm x 28 mm Full Thread Bio-Interference Screw, 12 mm x 28 mm

AR-1351B AR-1351LB AR-1351XLB AR-1351BT AR-1351LBT AR-1351 AR-1351L AR-1363 AR-1363L AR-1978S AR-1971S AR-1351K-CP AR-1351LK-CP AR-1351BK-CP AR-1351BLK-CP AR-1999 AR-1997SH AR-1990 AR-1370TB AR-1380TB AR-1390TB AR-1400TB AR-1403TB AR-1404TB

Femoral and Tibial Tunnel Placement Instrumentation: ACL Cruciate Reconstruction ToolBox Set Transtibial ACL Reconstruction Set

Recommended Graft Prep Suture: #2 FiberLoop w/Straight Needle #2 TigerLoop w/Straight Needle

Passing Suture: #2 TigerWire

AR-1900S AR-1817AS AR-7234 AR-7234T AR-7203

This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s Directions For Use.

Actual size of metal TransFix Implant

U.S. PATENT NOS. 5,895,425; 5,918,604; 6,132,433; 6,371,124; 6,537,319; 6,544,281; 6,623,524; 6,629,977; 6,733,529; 6,875,216; 6,974,477; 7,066,956; 7,077,863; 7,306,626 and PATENTS PENDING

© 2011, Arthrex Inc. All rights reserved. LT0125D

BTB TransFix ACL Reconstruction

Bone Tendon Bone Bio-TransFix® II ACL Reconstruction

Ordering Information: TransFix II ACL Reconstruction Set (AR-1817TS)

Surgical Technique

BTB TransFix Implants & Disposables (single use & sterile):

Bone Tendon Bio-TransFix, 3 mm x 40 mm AR-135IBT Bone Tendon Bio-TransFix, 3 mm x 50 mm AR-1351LBT TransFix II Drill Set AR-1978S

TransFix Implants & Disposables: Actual size of Bone Tendon Bio-TransFix Implant

Bio-TransFix Implant, 5 mm x 40 mm Bio-TransFix Implant, 5 mm x 50 mm (b) Bio-TransFix Implant, 5 mm x 60 mm Bone Tendon Bio-TransFix, 3 mm x 40 mm Bone Tendon Bio-TransFix, 3 mm x 50 mm (d) TransFix Implant, 3 mm x 40 mm, titanium (c) TransFix Implant, 3 mm x 50 mm, titanium TransFix Screw, 3 mm x 40 mm, titanium (a) TransFix Screw, 3 mm x 50 mm, titanium

Disposables:

TransFix Disposables Kit, sterile BTB TransFix II Pin and Graft Passing Wire Set Metal TransFix Convenience Pack, 40 mm Metal TransFix Convenience Pack, 50 mm Bio-TransFix Convenience Pack, 40 mm Bio-TransFix Convenience Pack, 50 mm

Delta Screw Tibial Fixation Instrumentation: Ratcheting Screwdriver Handle Cannulated Short Screwdriver Shaft for Bio-Interference Screws Torque Measurement Device

Actual size of 7 mm x 28 mm Full Thread Bio-Interference Screw

Tibial Fixation Implants:

Full Thread Bio-Interference Screw, 7 mm x 28 mm Full Thread Bio-Interference Screw, 8 mm x 28 mm Full Thread Bio-Interference Screw, 9 mm x 28 mm Full Thread Bio-Interference Screw, 10 mm x 28 mm Full Thread Bio-Interference Screw, 11 mm x 28 mm Full Thread Bio-Interference Screw, 12 mm x 28 mm

AR-1351B AR-1351LB AR-1351XLB AR-1351BT AR-1351LBT AR-1351 AR-1351L AR-1363 AR-1363L AR-1978S AR-1971S AR-1351K-CP AR-1351LK-CP AR-1351BK-CP AR-1351BLK-CP AR-1999 AR-1997SH AR-1990 AR-1370TB AR-1380TB AR-1390TB AR-1400TB AR-1403TB AR-1404TB

Femoral and Tibial Tunnel Placement Instrumentation: ACL Cruciate Reconstruction ToolBox Set Transtibial ACL Reconstruction Set

Recommended Graft Prep Suture: #2 FiberLoop w/Straight Needle #2 TigerLoop w/Straight Needle

Passing Suture: #2 TigerWire

AR-1900S AR-1817AS AR-7234 AR-7234T AR-7203

This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s Directions For Use.

Actual size of metal TransFix Implant

U.S. PATENT NOS. 5,895,425; 5,918,604; 6,132,433; 6,371,124; 6,537,319; 6,544,281; 6,623,524; 6,629,977; 6,733,529; 6,875,216; 6,974,477; 7,066,956; 7,077,863; 7,306,626 and PATENTS PENDING

© 2011, Arthrex Inc. All rights reserved. LT0125D

BTB TransFix ACL Reconstruction

Bone Tendon Bone Bio-TransFix® II ACL Reconstruction