Technique Guide. *smith&nephew MAGNUM 2 Knotless Implant

Transcription

1 Technique Guide *smith&nephew MAGNUM 2 Knotless Implant

2 MAGNUM 2 knotless implant The MAGNUM 2 implant increases surgeon control by combining independent cortical bone lock, suture lock, and incremental tissue tensioning, resulting in a streamlined and secure soft tissue repair. Suture lock button Suture ratchet knobs Ratchet release button Suture support Distal snare wire loop MAGNUM 2 implant Distal snare ring MAGNUM 2 implant (OM-1502) Disposable inserter handle Hand lever In addition, the system includes the slotted drill guide with blunt obturator, drill punch, and PATHFINDER The SMARTSTITCH suturing device The SMARTSTITCH system is an integrated grasper and suturing mechanism that allows the surgeon to grasp the cuff tissue and quickly place an Incline Mattress, or side-to-side stitch. The SMARTSTITCH system consists of a reusable SMARTSTITCH handle and a single use PERFECTPASSER or M-Connector insert. In addition, the MAGNUMWIRE suture used with the MAGNUM 2 implant is a strong #2 braided polyethylene suture available in multiple colors to facilitate suture management. SMARTSTITCH suturing device with PERFECTPASSER insert Connector release button PERFECTPASSER (OM-8010) Suture cartridge (OM-817X) M-Connector (OM-8007) Needle driver lever Clamp jaw lever Ratchet release lever Suturing device handle (OM-8000) SMARTSTITCH suturing device with M-Connector insert

3 Creating drill/punch holes for the MAGNUM 2 knotless implant The drill hole sites are planned by applying traction on the suture limbs. The cuff footprint is prepared by removing all soft tissue and creating a smooth bone surface in preparation for implant placement. It is important not to decorticate bone in the vicinity of the implant sites as the MAGNUM 2 implant relies on an intact cortical layer for bone fixation. 1 Optionally, insert the MAGNUM 2 drill guide, with blunt obturator, through the working portal. 2 If using the blunt obturator, remove the device and, using a suture retriever through the drill guide, shuttle one pair of sutures into the working portal. NOTE: If a perpendicular angle cannot be achieved through the standard lateral portal, it is recommended that an additional superolateral portal be made closer to the acromion border. The perpendicular alignment should be confirmed with a spinal needle prior to creating the portal. 3 Make the drill or punch holes perpendicular to the bone surface (as opposed to a 45 degree angle), as this ensures optimal fixation by the MAGNUM 2 implant. It is important to penetrate the bone up to the collar on the drill (or punch) in order to achieve the correct depth for deployment of the MAGNUM 2 implant. Correct angle Wrong angle NOTE: If using the drill guide, make sure to hold the sutures away in the slot of the guide while creating the bone hole. 4 Once the hole is made, remove the drill (or punch) and optionally insert the Pathfinder instrument into the hole to maintain alignment while the MAGNUM 2 implant is prepared for insertion. NOTE: If placing more than one implant, assure bone holes are at least 7mm apart. Please refer to the Instructions for Use (IFU) packaged with the product for a complete list of Warnings, Precautions and Contraindications.

4 Deploying the MAGNUM 2 knotless implant 1 Pass both limbs of the suture through the distal snare wire loop of the MAGNUM 2 implant handle. Remove the distal snare ring and adjust the suture so that approximately 6cm of suture extend from the distal end of the MAGNUM 2 implant handle. 6 cm Fig 1 2 Take up suture slack by rotating the suture ratchet knobs in the direction of the arrows on the inserter handle. Fig 2 3 If the PATHFINDER instrument was inserted, remove and insert the MAGNUM 2 device into the bone hole with the arrows on the suture support shaft pointed towards the stitch. NOTE: It is important to maintain perpendicular alignment during insertion of the MAGNUM 2 implant. Insert the MAGNUM 2 implant until the suture support shaft is fully seated against the bone. Fig 3 4 Rotate the suture ratchet knobs again to take up further suture slack until the entire length of suture is clearly visible, from the cuff tissue to the collar of the suture support shaft. Activate the bone lock by a single squeeze of the black hand lever. Verify bone purchase with a firm tug. Fig 4

5 5 Tension the sutures by rotating the suture ratchet knobs with both hands in the direction of the arrows on the inserter handle. Fig 5 6 When adequate tension between tendon and bone is achieved, press the suture lock button on the side of the inserter handle. Fig 6 7 Squeeze the black hand lever and release three times to activate the suture lock and allow withdrawal of the inserter handle. 3x Fig 7 8 Trim the sutures at the bone hole to complete the repair. Fig 8

6 Ordering information Reference # Description OM-1502 OM-9026 OM-9027 OM-9126 OM-9127 OM-9128 OM-9010 OM-9015 OM-9020 OM-9330 MAGNUM 2 2.8MM KNOTLESS IMPLANT MAGNUM 2 PLUS 2.8MM KNOTLESS IMPLANT SET WITH SMARTSTITCH MAGNUMWIRE SUTURE CARTRIDGE, WHITE MAGNUM 2 PLUS 2.8MM KNOTLESS IMPLANT SET WITH SMARTSTITCH MAGNUMWIRE SUTURE CARTRIDGE, BLUE CO-BRAID MAGNUM 2 PLUS 2.8MM KNOTLESS IMPLANT SET WITH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, WHITE MAGNUM 2 PLUS 2.8MM KNOTLESS IMPLANT SET WITH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, BLUE CO-BRAID MAGNUM 2 PLUS 2.8MM KNOTLESS IMPLANT SET WITH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, BLACK CO-BRAID 3.2MM SPADE DRILL DRILL GUIDE AND PATHFINDER SET: COMPATIBLE WITH OM-9010, OM-9020, OM-9410 AND OM MM BONE PUNCH AUTOCUFF METAL INSTRUMENT TRAY ArthroCare Corporation 7000 West William Cannon Drive Austin, TX USA Order Entry: Order Entry Fax: Smith & Nephew, Inc. Trademark of Smith & Nephew. Reg. US Pat. & TM Office. P/N A1022 Rev. H 01/15