Infinity Suture Shuttle Instructions for Use

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Infinity™ člnok chirurgického vlákna

Pripomoček za napeljavo suture Infinity™

Table Caption: This table lists various languages and assigns a corresponding numerical value to each, with the numbers increasing sequentially.

ENGLISH

I nfinity ™ S uture S huttle

Table Caption: This table lists catalog numbers and their corresponding product descriptions, with "KSP100" being the catalog number for the "Infinity™ Suture Shuttle".

DESCRIPTION

The Infinity™ Suture Shuttle (KSP100) is a plastic tube and nitinol loop used to capture and retain free strands of suture in order to pass through portals and bone tunnels. The nitinol loop expands when exposed out of the tube and contracts when retracted into the tube. The movement of the loop relative to the tube is performed manually.

MATERIAL SPECIFICATIONS

Sheath: FEP (fluorinated ethylene-propylene)

Threader: 304 SST, Nitinol and polyolefin shrink tubing

INTENDED USE/INDICATIONS FOR USE

The Infinity™ Suture Shuttle is intended to pass suture through portals and tunnels in arthroscopic knee procedures including Anterior Cruciate Ligament and Posterior Cruciate Ligament reconstruction.

CONTRAINDICATIONS

1. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials.

WARNINGS

1. Only surgeons experienced in the appropriate specialized procedure should use this product. It is the responsibility of the surgeon to become familiar with the proper procedures.
2. Do Not Resterilize. Single Use Only. The ability to effectively clean and resterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device. STERILIZE
3. 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.
4. Remove items from the sterile package using aseptic technique.
5. 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 use.

PRECAUTIONS

1. Before inserting and removing shuttle into and from the portal, ensure the nitinol wire loop is securely tucked into the plastic tubing.
2. Federal Law (USA) restricts this device to sale by or on the order of a physician.
3. To avoid damage or breakage during use, do not use excessive force on product.
4. Inspect device prior to use and after removal to ensure it is in good physical condition.

ADVERSE EVENTS

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

INSTRUCTIONS FOR USE

1. Retract the nitinol loop into the plastic sheath.
2. Insert the Suture Shuttle device into the bone tunnel.
3. Push to extend threader up, exposing the nitinol loop.
4. Retrieve the nitinol loop to bring the loop outside of the joint for loading.
5. Thread at least two inches of the suture strand(s) through the wire loop ( Figure 1 ).
6. Retract the threader with suture loaded, securing the suture to the sheath.
7. Pull the Suture Shuttle back out of the tunnel until the suture is completely threaded through.
8. Expose the nitinol loop to release the suture.

PACKAGING, LABELING AND STERILIZATION

1. The Infinity™ Suture Shuttle should only be used if the original packaging and labeling are intact.
2. If the Infinity™ Suture Shuttle has been opened or altered, contact your local CONMED representative, or in the U.S. contact the Customer Service Department.
3. The Infinity™ Suture Shuttle is supplied sterile, single use. Resterilization by any method is not recommended.

SYMBOLOGY

The following are descriptions of the graphical symbols used to label CONMED Corporation products:

Table Caption: This table lists various symbols and terms found on medical device packaging, providing guidance on their meaning and indicating important usage and safety instructions. It covers information such as catalog numbers, sterilization methods, usage restrictions, manufacturer details, and regulatory markings.

CONTACT INFORMATION

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

FRANÇAIS

Passe fils I nfinity ™

**Table Caption: This table lists a product reference, "KSP100," and its description, "Passe fils