MAUDE Adverse Event Report: CONMED CORPORATION Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR WITH TWO #2 (5 METRIC) HI-FI SUTURES (1 WHIT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	Y1802A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged broken y1802a is not expected to be returned for evaluation and review.This complaint of broken device is unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: warnings: preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of implants are important considerations in the successful utilization of these devices.Surgeon must choose proper implant size based on specific procedure and patient history.Precautions: inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instruments after use to ensure they have not been damaged.Instruments are designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques for use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, y1802a, was being used during a ligament reconstruction atfl repair when the stainless-steel tip of the instrument was broken with the anchor was inserted into the bone.The anchor was removed, and the tip was removed.There was no delay to the procedure.The procedure was completed as planned.There was no impact to the patient or the user.There was no medical intervention or hospitalization reported.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR WITH TWO #2 (5 METRIC) HI-FI SUTURES (1 WHIT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo, fl
• MDR Report Key: 10419576
• Report Number: 1017294-2020-00330
• Device Sequence Number: 14188637
• Product Code: MBI
• UDI-Device Identifier: 10845854041796
• UDI-Public: (01)10845854041796(17)240930(10)1052062
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: Y1802A
• Device Lot Number: 1052062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1