DePuy Synthes Mitek Sports Medicine ACL RECONSTRUCTION

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DePuy Synthes Mitek Sports Medicine ACL RECONSTRUCTION WITH RIGIDLOOP BTB ADJUSTABLE CORTICAL SYSTEM Surgical Procedure

Table of Contents Introduction 4 Surgical Procedure Graft Harvest and Preparation 5 Button Attachment to Femoral Side Bone Plug 6 Femoral Socket Retrograde Reaming 8 Tibial Tunnel Reaming 8 Graft Fixation on the Femur 9 Final Fixation 11 Suture Cutting 11 TWISTR Retrograde Reamer & Cruciate Instruments 12 Suture and Suture Passers 12 RIGIDLOOP System 13 MILAGRO ADVANCE Interference Screw 13 Ordering Information ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 3

Introduction Special Thank You This surgical procedure guide was written with the assistance of Dr. Karen Sutton. Dr. Sutton is a board-certified sports medicine surgeon with surgical expertise in arthroscopy of the shoulder and knee. Dr. Sutton is an Associate Attending Orthopedic Surgeon at the Hospital for Special Surgery and is a member of the Sports Medicine Institute and Women’s Sports Medicine Center at HSS. She is also Chief Medical Officer for World Lacrosse and Team Physician for US Ski & Snowboard. Dr. Sutton is a paid consultant for DePuy Synthes Mitek Sports Medicine. This presentation reflects the techniques, approaches and opinions of the individual presenter. This DePuy Synthes, Inc. sponsored presentation is not intended to be used as a training guide. Other surgeons may employ different techniques. The steps demonstrated may not be the complete steps of the procedure. Individual surgeon preference and experience, as well as patient needs, may dictate variation in procedure steps. Before using any medical device, review all relevant package inserts with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device(s). 4 Surgical Procedure ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System

Surgical Procedure Graft Harvest and Preparation Harvest a BTB graft according to surgeon preference. Please account for the following aspects of graft preparation: Bone Plug: RIGIDLOOP BTB Adjustable Cortical System attaches to the bone plug using two sutures and two holes. Bone Plug Length: A bone plug shorter than 20mm is easier to pass through the knee and into the socket. Overall Length: When the overall length of the graft exceeds 90mm, adapt your technique to account for this. There are three ways to adapt your technique to handle a longer graft: drill a longer femoral tunnel, drill a longer tibial tunnel, or manage excess graft outside the tibial tunnel. Use a sagittal saw and rongeur to cut and shape the femoral and tibial bone plugs. Use a rongeur to bullet the femoral bone plug. Drill two 1.5mm diameter holes on the femoral side bone plug. Drill two 1.5mm diameter holes on the tibial side bone plug. These holes will be used for traction sutures. The diagram shows holes drilled perpendicular to each other, but the orientation (and even number of holes) is a matter of surgeon preference. ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 5

Surgical Procedure Button Attachment to Femoral Side Bone Plug Unpack a RIGIDLOOP BTB Adjustable Cortical System - Standard. Grasp it with two fingers, as shown, to avoid pulling the black relay loops out of the assembly. Hold the preparation card flat against a table. Insert the femoral bone plug flush against the graft clamp on the button’s preparation card. The drill holes must be oriented as shown. Completely unravel one of the two white tensioning sutures. It doesn’t matter which side is chosen. 6 Surgical Procedure ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System

Surgical Procedure Using a suture passing device such as a CHIA PERCPASSER Suture Passer or a free needle with kite, pass the white tensioning suture through the proximal bone plug hole and the opposing black relay loop. Note: “ Proximal” in this context means the bone plug hole that is closest to the button. Pull the corresponding black relay loop gently in a plane horizontal with the graft. Exercise slight counter-tension on the white suture, and once the white suture has entered the splice in the button, apply slow lateral movements (“wiggles”) to the end of the temporary black relay loop. Do this until the suture has fully exited the splice. Pull the tensioning suture to eliminate slack in the loop. Wind the excess length of the tensioning suture around the winder and wedge it in the notch to lock it. Unwind the second white tensioning suture. Pass it through the distal drill hole in the opposite direction of the first tensioning suture. “Wiggle” it through the splice using the same technique utilized for the proximal suture. Insert two sutures into the tibial bone plug drill holes. These sutures will be used to control placement of the tibial bone plug. ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 7

Surgical Procedure Femoral Socket Retrograde Reaming Drill the femoral socket using the TWISTR Retrograde Reamer according to the IFU. Insert a relay suture using an outside-in suture passing pin. Tibial Tunnel Reaming Drill the tibial tunnel from the outside-in using a fluted reamer. Reamer size and tunnel location should be chosen according to surgeon preference. Use a shaver or rasp to chamfer the edges of the socket entrance and ease bone block passage into the socket. 8 Surgical Procedure ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System

Surgical Procedure Graft Fixation on the Femur Remove the RIGIDLOOP BTB Adjustable Cortical System and graft from the preparation card. Unwind all sutures from the button preparation card. Remove the button from the card by lifting up all the sutures. Pull on the femoral bone plug to remove it from the clip on the preparation card. Gently pull on each of the two suture loops to lengthen the distance from the underside of the button to the beginning of the femoral bone plug to 6cm or more. Mark the total transosseous length on the femoral side suture loop. This mark is an indication of where to flip the button. Use the relay suture to pull the RIGIDLOOP BTB Adjustable Cortical System sutures through the femoral socket. Pull the RIGIDLOOP BTB Adjustable Cortical System into the joint space. Pull lightly on the blue/white suture to position the button near the entrance of the femoral socket. Use the blue/white suture to pull the button through the socket, and lightly pull other sutures, as needed, to avoid tangles. Switching the arthroscope to the AM portal may allow for a clearer view of the button and may facilitate passage of the button and bone block into the femoral socket. ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 9

Surgical Procedure Flip the button by pulling on the green flipping suture. Alternately pull on the green suture and the blue/white suture to confirm the button is on the cortex and has successfully flipped. Throughout the process of flipping the button and testing for flip success, maintain counter tension on the graft to ensure the button stays on the cortex. Pull alternately on the white tensioning sutures of the button until the bone plug is at the entrance of the femoral socket. Use a probe to help position the bone plug. When the bone plug is positioned to surgeon preference, alternately pull on the white tensioning sutures until the bone plug is fully seated in the femoral socket. 10 Surgical Procedure ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System

Surgical Procedure Final Fixation Fix the graft in place in the tibial tunnel using a MILAGRO ADVANCE Interference Screw according to the IFU. Cycle the knee and adjust button tension until satisfied with graft tension. Suture Cutting Remove the green and blue/white sutures from the RIGIDLOOP BTB Adjustable Cortical System. Cut the white tensioning sutures. Leave at least 6mm of tail, as this is essential for sustained tension. ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 11

Ordering Information Product Codes TWISTR Retrograde Reamer & Cruciate Instruments Suture and Suture Passers 232000 TWISTR Retrograde Reamer 214101 CHIA PERCPASSER Suture Passer 232301 Outside-In Disposables Kit 222069 219001 Side-Loading Guide Carriage 2 DYNACORD Suture Pack Striped/ # Blue (without needles) 219002 Retroreamer Bullet Obturator 222067 219003 Beath Pin Bullet 2 DYNACORD Suture Pack Blue # (without needles) 219004 Retroreamer Bullet 222068 2 DYNACORD Suture Pack Striped # (without needles) 219005 2.4mm Insert For RR Bullet 222065 219006 ACL Tibial Point Aimer 2 DYNACORD Suture Pack Blue # (with OS-6 needles) 219007 ACL Tibial Capture Aimer 222066 219008 ACL/PCL Femoral Point Aimer 2 DYNACORD Suture Pack Blue # (with MO-7 needles) 219009 ACL/PCL Femoral Capture Aimer 223105 #2 ORTHOCORD Suture Violet (without needles) 219011 PCL Tibial Point Aimer 223111 219012 PCL Tibial Disc Aimer #2 ORTHOCORD Suture Blue (without needles) 219015 Cannulated PCL Elevator 223104 219013 PCL Rasp #2 ORTHOCORD Suture Violet (with MO-7 needles) 219017 Pin Depth Gage 223103 219018 Outside-In Suture Passing Pin #2 ORTHOCORD Suture Violet (with OS-6 needles) 215203 Sterilization Tray 215205 Sterilization Tray Lid 12 Surgical Procedure ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System

Ordering Information Product Codes RIGIDLOOP System MILAGRO ADVANCE Interference Screw 232485 IGIDLOOP BTB Adjustable Cortical R System - Standard† 231816 MILAGRO ADVANCE BR Interference Screw, 7 x 23mm 232486 IGIDLOOP BTB Adjustable Cortical R System - XL† 231817 MILAGRO ADVANCE BR Interference Screw, 8 x 23mm 232453 Combo Beath/Drill Pin - 4.5mm (Sterile) 231818 218034 IGIDLOOP Adjustable Disposables Kit R (Sterile) MILAGRO ADVANCE BR Interference Screw, 9 x 23mm 231819 MILAGRO ADVANCE BR Interference Screw, 10 x 23mm 231856 MILAGRO ADVANCE PEEK Interference Screw, 7 x 23mm 231857 MILAGRO ADVANCE PEEK Interference Screw, 8 x 23mm 231858 MILAGRO ADVANCE PEEK Interference Screw, 9 x 23mm 231859 MILAGRO ADVANCE PEEK Interference Screw, 10 x 23mm ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 13

14 Surgical Procedure ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System

ACL Reconstruction with RIGIDLOOP BTB Adjustable Cortical System Surgical Procedure 15

The third party trademarks used herein are the trademarks of their respective owners. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Please refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. † Made By: S.B.M. SAS ZI du Monge 65100 LOURDES FRANCE Phone: 33 (0) 5 62 42 21 01 Fax: 33 (0) 5 62 42 21 00 Web: www.sbm-france.us www.depuysynthes.com DePuy Synthes 2021, 2023. All rights reserved. 175544-220802 DSUS/EMEA Medos International SÀRL Chemin-Blanc 38 CH-2400 Le Locle Switzerland DePuy Mitek, Inc. 325 Paramount Drive Raynham, MA 02767 T. 1 (800) 382-4682

This surgical procedure guide was written with the assistance of Dr. Karen Sutton. Dr. Sutton is a board-certified sports medicine surgeon with surgical expertise in arthroscopy of the shoulder and knee. Dr. Sutton is an Associate Attending Orthopedic Surgeon at the Hospital for Special Surgery and is a member of the Sports Medicine Institute and

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