Suture Passer Instruments Instructions for Use

Zimmer GmbH Sulzerallee 8 8404 Winterthur Switzerland

English

SUTURE PASSER INSTRUMENTS Instructions for Use DESCRIPTION The Suture Passer reusable instruments made by Cayenne Medical, Inc. are accessory items designed to address specific performance requirements of passing suture and/or repairing soft tissue. The Suture Passers are designed to be used with the Quattro Suture Passer Needle ® ® and TRU-LINK , TRU-LOOP or MaxBraid™ USP #2 round suture or #2 BroadBand™ Suture Tape. Suture Passer Instruments can be reused after appropriate cleaning and sterilization. The Quattro Suture Passer Needle is offered separately and comes packed sterile and is intended for single patient use only. The TRU-LINK, TRU-LOOP or MaxBraid USP #2 round suture or #2 BroadBand SutureTape are sterile packed and offered separately. ®

CM-9010 - Quattro Suture Passer ® CM-9010GT - Quattro GT Suture Passer ® CM-9010GTS - Quattro GTS SideLoad Suture Passer ® CM-9010LS - Lock-Stitch Suture Passer INDICATIONS The Suture Passer Instruments are intended for use during general orthopedic surgical procedures. WARNINGS AND PRECAUTIONS Warnings • All Suture Passer Instruments are provided NON-STERILE. Care must be taken to properly clean and sterilize the instruments prior to each use. • All safety caps and other packaging materials must be removed prior to cleaning and sterilization. • Prior to use of the Quattro & Lock-Stitch Suture Passers the Suture Passer Lifespan Manual (located on www.zimmerbiomet.com) should be followed to assist the user in determining whether a Suture Passer is suitable for use. • If the instrument does not function properly and smoothly, immediately discontinue use and contact a Cayenne Medical Customer Service Representative. • When using a cannula, a cannula with an inside diameter of 6.5mm diameter or larger must be used for the Quattro Suture Passers during arthroscopic shoulder repair. • When using a cannula, a cannula with an inside diameter of 7.0mm diameter or larger must be used for Lock-Stitch suture passer during arthroscopic shoulder repair. • As with any surgical instrument, careful attention should be made to assure that unusual or excessive force is not placed on this instrument. Unusual or excessive force can result in failure. Precautions • A surgeon should not begin clinical use of the instrument without reviewing the instructions for use or practicing the procedure in a skills laboratory. • Additional precautions include those applicable to any surgical procedure. Careful attention must be devoted to avoiding all surgical hazards including (but not limited to) infection, neurovascular damage, excessive tourniquet time, thermal/frictional trauma to cutaneous structures. • The Quattro and Lock-Stitch Suture Passers are designed for use with the Quattro Suture Passer Needle and TRU-LINK, TRU-LOOP or MaxBraid USP #2 round suture or #2 BroadBand Suture Tape. Use of the Quattro and Lock-Stitch Suture Passers with other suture needles or sutures may compromise the integrity of the instrument. • Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated

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medical devices. Caution should be exercised when handling devices with sharp points or cutting edges. Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers. Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and pipe cleaners should be used. Do not place heavy instruments on top of delicate devices. Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluid, bone and tissue debris, saline, or disinfectants to dry on used instruments.

Hospital Responsibilities for Zimmer Biomet Instruments • Orthopedic surgical instruments generally have a long service life; however, mishandling or inadequate protection can quickly diminish their life expectancy. Instruments which no longer perform properly because of long use, mishandling, or improper care should be returned to Zimmer Biomet to be discarded. Notify your Zimmer Biomet representative of any instrument problems. • The instructions provided in this manual have been validated by Cayenne Medical in the laboratory and are capable of preparing orthopedic devices for use. It is the responsibility of the Hospital to ensure that reprocessing is performed using the appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained in order to achieve the desired result. • Prior to use of the Quattro & Lock-Stitch Suture Passers the Suture Passer Lifespan Manual (located on www.zimmerbiomet.com) should be followed to assist the user in determining whether a Suture Passer is suitable for use. • Equipment and processes should be validated and routinely monitored. Any deviation by the processor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences. MATERIALS Surgical grade stainless steel. INSTRUCTION FOR USE Prior to use of the Quattro & Lock-Stitch Suture Passers the Suture Passer Lifespan Manual (located on www.zimmerbiomet.com) should be followed to assist the user in determining whether a Suture Passer is suitable for use. 1.

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Load the distal tip of the Quattro Suture Needle into the Quattro or Lock-Stitch Suture Passer. Advance the needle until the posts on the suture needle tab fall into the designated needle holder slots on the handle of the passer. You may need to push the tab into place to secure. Make a one inch suture loop with USP #2 suture and load into the slot of the bottom jaw with the suture tail facing down through the slot. a. NOTE: The slot can be found at the distal end of the Quattro, Quattro GT and Lock-Stitch Suture Passers and at the side of the Quattro GTS Suture Passer. While pulling tension on the suture against the back of the slot, lightly squeeze the handle to advance the needle no more than 2-3mm to capture the suture in the needle. Release tension on the hand piece to retract the needle. The suture is now loaded. a. Confirm the suture is loaded by lightly pulling on the suture tail end

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