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

Catalog Number	YP1301RW
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
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.
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, ¿one side of the u-shaped part of the shaft at the tip of the anchor broke.The bone was hard, so it was necessary to use a little force when inserting it, which is thought to have caused more stress than necessary to be placed on the tip.This has been occurring frequently in recent cases of dislocation, and users are calling for improvements to the tip strength.".There was no report of medical intervention or hospitalization for the patient.Further assessment was requested, and it was reported that the device fragmented in the patient and the fragmentation was not retrieved.The reporter did not explain why the fragmentation was not retrieved.There was no delay to the procedure, and the procedure was completed as planned.This report is being raised due to the reported injury of foreign body left in patient.
Additional Manufacturer Narrative
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.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (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.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.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 18dec25 when it was reported, ¿one side of the u-shaped part of the shaft at the tip of the anchor broke.The bone was hard, so it was necessary to use a little force when inserting it, which is thought to have caused more stress than necessary to be placed on the tip.This has been occurring frequently in recent cases of dislocation, and users are calling for improvements to the tip strength.".There was no report of medical intervention or hospitalization for the patient.Further assessment was requested, and it was reported that the device fragmented in the patient and the fragmentation was not retrieved.The reporter did not explain why the fragmentation was not retrieved.There was no delay to the procedure, and the procedure was completed as planned.This report is being raised due to the reported injury of foreign body left in patient.

• 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: 23988644
• Report Number: 1017294-2026-00003
• Device Sequence Number: 19991200
• Product Code: MBI
• UDI-Device Identifier: 20845854649036
• UDI-Public: (01)20845854649036(17)281030(10)1351756
• 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): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: YP1301RW
• Device Lot Number: 1351756
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic