MAUDE Adverse Event Report: CONMED Y-Knot; Fastener, fixation, nondegradable, soft tissue

Catalog Number	YP1802
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf of the customer that the device yp1802, y-knot pro flex 1.8 mm anchor, two no.2 hi-fi was being used and ¿on (b)(6) 2026, dr.From (b)(6) hospital in (b)(6) was performing a shoulder joint arthroscopy-based labrum repair surgery and during the process, he discovered that the insertion rod head of the anchor had a missing tooth after the anchor was implanted.The broken tooth remained in the patient's body.¿ there was no impact or injury to the patient or user.This report is being raised due to the reported injury of fragment of the device remains in the patient.
Additional Manufacturer Narrative
G3 initial awareness date was (b)(6) 2026.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
Reported event "insertion rod head of the anchor had a missing tooth-not retrieved" was confirmed.The device will not be returned for evaluation; however, photographic evidence has been provided.Root cause cannot be determined, however, based upon photos; a possible cause of this event could be excessive force.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.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.A two-year review of complaint history revealed there has been a total of 14 reports, regarding 14 devices, for this device family and failure mode.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 the following: 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.We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: robin drum ; 525 french rd; utica, NY 13502 ; +1(865)388-1978
• MDR Report Key: 50206929
• Report Number: 1017294-2026-00148
• Device Sequence Number: 5482541
• Product Code: MBI
• UDI-Device Identifier: 20845854050689
• UDI-Public: (01)20845854050689(17)301008(10)1498908
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: YP1802
• Device Lot Number: 1498908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown