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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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Squeeze the trigger on the suture passer handle to close the jaw and advance through the cannula. a. When using a cannula with the Quattro Suture Passers, a cannula with an inside diameter of 6.5mm diameter or larger must be used. b. When using a cannula with the Lock-Stitch Suture Passer, a cannula with an inside diameter of 7mm diameter or larger must be used. Approximate the suture passer jaw to desired location and squeeze the trigger to grasp the tissue in the jaw. a. The Quattro Suture Passers have a tissue grasping depth of 16mm. It is not recommended to grasp deeper than 16mm. b. The Lock-Stitch Suture Passer is intended to grasp tubular tendons (i.e. biceps), not cuff tissue. Maintain pressure on the trigger and squeeze the handle to pass the needle and suture through the tissue. Release the trigger to free the grasp on the tissue and remove the suture passer from the joint space a. When using the Quattro GT, Quattro GTS or Lock-Stitch Passers, the suture will be captured in the suture passer jaw and can be pulled out of the same cannula b. When using the Quattro Suture Passer the suture will not be captured. Use desired suture retrieval method to secure and remove the passed suture from the joint space Squeeze the trigger and handle to release the captured suture from the suture passer (Applicable to Quattro GT, Quattro GTS and LockStitch Suture Passers)
CLEANING Immediately after each procedure, and before sterilization, the Suture Passers should be cleaned through either manual or automated cleaning techniques. Cayenne Medical recommends using Enzol® or other equivalent enzymatic detergent to clean the instruments. It is always important to clean instruments as soon as possible after use in order to limit the drying and encrustation of surgical soil. Cayenne Medical recommends using one of the following two cleaning methods for the cleaning of the Suture Passer instruments. Manual Cleaning: • Step 1: Completely submerge instruments in Enzol® enzymatic solution and lukewarm tap water according to manufacturer dilution specifications for 20 minutes. Scrub using a soft-bristled brush until all visible soil has been removed. It is important to make sure that the flutes are effectively cleaned. Use a small diameter brush or pipe cleaner to clean cannulation holes. Use a twist and pull motion to break up debris from both ends of the cannulation holes. Cleaning the cannulation holes and other complicated features of the instruments is the critical step in the cleaning process. Flush the lumens with at least 10ml of the prepared solution. NOTE: An ultrasonic cleaner may also be used in this step to break up surgical soil. • Step 2: Remove the devices from the enzymatic solution and rinse in warm tap water for 5 minutes. Thoroughly and aggressively flush devices. Use a syringe to flush cannulation holes making sure to remove all visible debris. • Step 3: Inspect devices to make sure they are visibly clean. If visible foreign material remains, repeat steps 1-3.
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the cannulation holes and other complicated features of the instruments is the critical step in the cleaning process. Flush the lumens with at least 10ml of the prepared solution. NOTE: An ultrasonic cleaner may also be used in this step to break up surgical soil. Step 2: Remove the devices from the enzymatic solution and rinse in warm tap water for 2 minutes. Thoroughly and aggressively flush devices. Use a syringe to flush cannulation hole making sure to remove all visible debris. Step 3: Place devices in washer/disinfector and process using the following standard instrument cycle: Phase
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Water Temperature
Pre-wash 1 Enzyme Wash
Precirculation time (mm:ss) 02:00 01:00
Wash 1
02:00
66°C (Set Point)
Rinse 1 Drying
00:15 07:00
Hot tap water 115.5°C
Cold tap water Hot tap water
Detergent Type and Concentration (If Applicable) N/A Enzol, ¼ oz./gallon Prolystica Neutral Detergent, 1/8 oz./gallon N/A N/A
Step 4: Once the washer/disinfector cycle has been completed, inspect the instruments for visible debris. If visible foreign material remains, repeat steps 1-4.
LUBRICATION Instruments with hinged, rotating, or articulating parts should be lubricated with an instrument product (e.g. Instrument Milk or equivalent lubricant) specifically designed for compatibility with steam sterilization, to reduce friction and wear. STERILIZATION The Suture Passer instruments may be steam autoclaved following cleaning. The operator should follow the sterilizer manufacturer’s instructions for steam sterilization cycle parameters. It is recommended that the wrapped instrument set be steam autoclaved using the following sterilization times and temperatures: Pre-vacuum Sterilization Cycle: 2.5 psia pre-exposure evacuation Exposure Temperature: 132°C (270°F) Exposure Time: • 4 Minutes for all Shoulder Surgical Instruments Post-Sterilization Drying Time: • 60 Minutes for all Shoulder Surgical Instruments
Washer-Disinfector Cleaning: • Step 1: Completely submerge instruments in Enzol® enzymatic solution and lukewarm tap water according to manufacturer dilution specifications for 10 minutes. Scrub using a soft-bristled brush until all visible soil has been removed. It is important to make sure that the flutes are effectively cleaned. Use a small diameter brush or pipe cleaner to clean cannulation holes. Use a twist and pull motion to break up debris from both ends of the cannulation holes. Cleaning 71263 Rev D
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Manufactured By Cayenne Medical, a Zimmer Biomet Company 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 U.S.A. CUSTOMER SERVICE +1(480) 502-3661 +1(888) 229-3661 Fax: +1(480) 502-3670 www.cayennemedical.com KEY TO SYMBOLS ON LABELING
Lot number
Reference number
Consult Instructions for Use
Manufactured By CAUTION: Federal law (USA) restricts this device to sale only by or on the order of a physician.
Cayenne Medical is a trademark of Cayenne Medical, Inc. All rights reserved. Printed in the USA.
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