MAUDE Adverse Event Report: CONMED Y-KNOT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	YP1301RW
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, yp1301rw, y-knot pro flex 1.3 mm anchor, ribbon white/black, was being used during an abr procedure on (b)(6) 2025 when it was reported, ¿when using the third yknot, the tip of the inserter broke.There was no problem with the usage procedure, and the bone was not hard, so the cause was unclear.However, even when examining the tip of an anchor that was inserted normally without breaking, the u-shaped portion of the inserter was slightly expanded after insertion, suggesting that a significant amount of force was applied.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment was requested; however, to date conmed has not received a response.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Correction: d3, updated to legal mfg.Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.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 to 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.It is the responsibility of the surgeon to become familiar with the proper techniques for use.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, yp1301rw, y-knot pro flex 1.3 mm anchor, ribbon white/black, was being used during an abr procedure on (b)(6) 2025 when it was reported, ¿when using the third yknot, the tip of the inserter broke.There was no problem with the usage procedure, and the bone was not hard, so the cause was unclear.However, even when examining the tip of an anchor that was inserted normally without breaking, the u-shaped portion of the inserter was slightly expanded after insertion, suggesting that a significant amount of force was applied." there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment was requested; however, to date conmed has not received a response.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: Y-KNOT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23569508
• Report Number: 1017294-2025-00118
• Device Sequence Number: 9859503
• Product Code: MBI
• UDI-Device Identifier: 20845854649036
• UDI-Public: (01)20845854649036(17)290305(10)1375461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Catalogue Number: YP1301RW
• Device Lot Number: 1375461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic