Concept Suture Passer System Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE

Concept® Suture Passer System Catalog #

Description

SMI-00M

Suture Passer

Non-Sterile

SMI-00D

Suture Passer Needle

Sterile

Material Specifications

Supplied

STERILE

Stainless Steel

EO

Nitinol ABS Coated

DESCRIPTION

The Concept® Suture Passer (SMI-00M) is a reusable instrument used to pass #2 Hi-Fi® (5 metric) suture through soft tissue in arthroscopic or open surgical procedures. Sterilize before each use following the “CLEANING AND STERILIZATION GUIDELINES for the SUTURE PASSER” on page 4. The Suture Passer is designed to be used with a 5.5mm or larger cannula. The Concept Suture Passer Needle (SMI-00D) is a single use, 2 disposable device designed to be used with the Suture Passer. Do Not Re-sterilize.

STERILIZE

INTENDED USE/ INDICATIONS FOR USE The Suture Passer is intended to manually pass and retrieve #2 Hi-Fi (5 metric) suture through soft tissue in either arthroscopic or open surgical procedures. The Suture Passer Needle is intended to work in conjunction with the Suture Passer to manually pass and retrieve #2 Hi-Fi (5 metric) suture through soft tissue in either arthroscopic or open surgical procedures.

CONTRAINDICATIONS 1. 2. 3. 4. 5.

Pathological conditions in the soft tissue to be repaired or reconstructed which would adversely affect suture fixation. Physical conditions that would eliminate, or tend to eliminate, adequate support or retard healing. Conditions which tend to limit the patient’s ability or willingness to restrict activities or follow directions during the healing period. Device is not to be used on bone or similar hard tissue. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials.

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WARNINGS

Suture Passer 1. 2. 3. 4. 5.

Avoid lateral stresses to the instrument or device function may be compromised. Do not use if parts are broken, cracked or worn, or device function may be compromised. Whether used arthroscopically or in open surgery the Suture Passer must be used under direct visualization. Sterilize before each use following the “CLEANING AND STERILIZATION GUIDELINES for the SUTURE PASSER” on page 4. If tissue is excessively thick or rolled and suture passer jaws do not close far enough there is a chance of suture passer needle missing the window of the suture retrieval mechanism.

Suture Passer Needle 1. 2. 3. 4.

5. 6. 7.

If the Suture Passer Needle kinks during use, immediately discontinue use and discard. There is an increased risk of needle breakage and unintentional patient injury may result. Do not use beyond the expiration date listed on the label. The performance, safety, and/or sterility of the device cannot be assured beyond the expiration date. Remove the Suture Passer Needle from the sterile package using aseptic techniques. Do Not Re-sterilize. Single Use Only. The ability to 2 effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device. In the event that a Suture Passer Needle is opened and not used, dispose according to hospital policy and procedure. The Suture Passer Needle contains a sharp tip at the distal end; handle with care. Patient should be advised that product materials may cause allergic reactions including but not limited to, foreign body reaction, tissue irritation/inflammation or other allergic reactions. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.

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PRECAUTIONS Suture Passer 1.

Prior to use, inspect instrument to ensure it is in good physical condition and functions properly. There should be no loose, broken or misaligned parts.

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2. 3. 4. 5. 6. 7. 8.

Do not attempt to use a suture size other than #2 Hi-Fi (5 metric) or suture may not pass. Do not attempt to pass more than one strand of suture at a time or the suture may not pass. Avoid mechanical shock or over stressing the instrument which may shorten the life of the instrument. To facilitate sterilization and proper function of the device, clean Suture Passer properly after each use. Instruments should be stored in the Shoulder Restoration System tray to protect the features. If used arthroscopically, do not use the Suture Passer through a cannula less than 5.5mm in diameter. Use only with Suture Passer Needle (SMI-00D).

Suture Passer Needle 1.

Do not use disposable suture passer needle for more than one (1) procedure. Reuse could cause fatigue and breakage of the needle, which may cause possible patient injury.

ADVERSE EVENTS 1. 2.

Infections, both deep and superficial. Allergies, tissue irritation/inflammation and other reactions to device materials.

INSTRUCTIONS FOR USE

Instructions for Loading the Suture Passer Needle into the Suture Passer 1. 2. 3.

With the Suture passer jaws in the closed position, insert the sharp end of the needle into the top of the instrument with the tab pointing up. Engage the needle by sliding the tab forward until it snaps into place. With the jaws closed, actuate the needle deployment trigger once to ensure that the needle deploys and retracts and that the suture retrieval mechanism opens during needle deployment and closes after needle retraction.

Instructions for Loading and Deploying Suture with the Suture Passer 1.

With the jaws of the Suture Passer open, load the suture into the suture slot located at the distal tip of the device and pull it completely to the proximal end of the suture slot. PRECAUTION: Use only #2 Hi-Fi (5 metric) suture with the Concept Suture Passer and Concept Suture Passer Needle. 2. If using the device in open surgery, dampen the jaws of the Suture Passer with sterile water. Also, if being used in an open procedure, omit the following references to the arthroscopic cannula.

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3.

With the suture loaded, and the jaws of the Suture Passer closed and the needle retracted, pass the Suture Passer through the cannula into the surgical site under direct visualization. The suture should be held slightly taut to ensure that it does not become entangled on itself or in the Suture Passer as it goes through the cannula. Note: The Concept Suture Passer should be used with a 5.5mm or larger cannula. 4. Once inside the joint space, open the jaws and position them at the desired location to pass the suture. Close the jaws securely on the tissue with a firm grasp. If jaws are not firmly closed on the tissue, the needle may miss the window of the suture retrieval mechanism. 5. Pull the needle deployment trigger to advance the needle and suture through the tissue. If excessive force is required to pass the needle, a smaller bite of tissue should be taken and the needle deployment should be attempted again. 6. After the suture is passed, release the needle deployment trigger allowing the needle to fully retract. Ensure jaws are kept closed until needle has fully retracted. If needle does not fully retract automatically, push the needle deployment trigger forward to fully retract it. 7. Open the jaws and remove the Suture Passer with suture loop from the cannula. PRECAUTION: If the Suture Passer Needle is not fully retracted, the Suture Passer will be difficult to remove from the tissue and the retriever mechanism will not have hold of the suture. 8. To remove suture from retriever mechanism pull the needle deployment trigger back slightly to open the trap door and pull suture.

CLEANING AND STERILIZATION GUIDELINES for the SUTURE PASSER WARNINGS: 1. 2.

The use of disinfecting solutions for exterior instrument wipe will not sterilize the equipment and is not recommended. Do not sterilize the Suture Passer Needle. It is single-use ONLY. Discard according to hospital policy and procedure.

PRECAUTIONS: 1. 2.

Follow universal precautions for protective apparel when handling and cleaning contaminated equipment. Do not drop sterilization tray or components.

PROCESS 1.

Remove the Suture Passer Needle from the handle and dispose immediately according to hospital policy and procedure.

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2. 3. 4. 5. 6. 7.

Leave the jaws for the Suture Passer in the opened position prior to sterilization. Do not use detergents with high acidic or high alkaline content. Manually clean the Suture Passer using a soft bristle brush on all outer surfaces with a neutral pH detergent until all visible blood and debris are removed. It is recommended that the Suture Passer be flushed as soon as possible to avoid coagulation occurring in the lumens. Rinse under running water followed by a rinse with DI water. Dry Suture Passer completely using clean, lint-free towel. If Suture Passer trigger mechanism binds, lubrication of moving parts can be performed with a water-soluble (medical grade) lubricant in accordance with manufacturer’s instructions before sterilization. Sterilization parameters for the Suture Passer using the SRS-Tray (RCR-Tray) with Instruments or Suture Passer without a Sterilization Tray Method

Cycle

Minimum Minimum Temperature Exposure

Minimum Dry Cycle

Steam (wrapped/ Pre-Vacuum unwrapped)

270°F (132°C)

4 minutes

Steam (wrapped/ unwrapped)

250°F (121°C)

30 minutes 25 minutes

Gravity

20 minutes

Note: Additional drying time may be required for complete heat and moisture dissipation.

PACKAGING AND LABELING 1. 2. 3.

The Concept Suture Passer Needle should only be used if the original packaging and labeling are intact. If the Concept Suture Passer Needle packaging has been opened or altered, contact your regional sales representative, or in the U.S. contact the Customer Service Department. The Concept Suture Passer Needle is supplied sterile and is single-use. Resterilization by any method is not recommended.

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CONTACT INFORMATION For more information or a product demonstration, contact your regional sales representative, or call 1-866-426-6633 in the U.S.

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2797 EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

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STERILIZE

STERILE

ConMed Corporation 525 French Road Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: CustomerExperience@conmed.com www.conmed.com ©2022 ConMed Corporation. All rights reserved.

LATEX

EO

W55-000-879

151

Rev AE

05/2022