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

Catalog Number	Y1301
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
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 distributor reported on behalf of their customer that the device, y1301, flex 1.3mm allsuture anch w/1-#2 wht/bl (5metric) hi-fi sutr, was used during an arthroscopic surgery, with the implant site being the ankle joint procedure on (b)(6) 2025 when it was reported, ¿the hospital newly purchased y1301 full-suture anchor bolts.After being hammered in, the small teeth at the front end broke, making this consumable unusable.¿.Further assessment was requested and reported advised, ¿when the anchor is implanted, the front-end forks and is soft, and the implanted part of the anchor body is long.During the positioning process, the direction is prone to deviation, and the front-end breaks after hitting the bone." a component had fallen into the surgical site and was retrieved using forceps.The procedure was completed without any report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot 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.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 20 complaints, regarding 23 devices, for this device family and failure mode.During this same time frame 37,425 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 0.0006.Per the instructions for use, the user is advised that when removing driver from pilot hole, pull driver straight out.Do not rotate or oscillate driver about its axis or breakage of driver tip and/or anchor may result.Maintain the drill guide at the same position and angle as it was when making pilot hole during insertion of anchors and disengagement of drivers.If anchor is inserted or driver is removed while the guide is not aligned, the driver tip may be damaged and the driver tip may remain on the patient¿s bone, resulting in injury.After inserting anchors and removing drivers, be sure to visually check that the driver tip is not damaged, as the driver tip may have been damaged during use.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 distributor reported on behalf of their customer that the device, y1301, flex 1.3mm allsuture anch w/1-#2 wht/bl (5metric) hi-fi sutr, was used during an arthroscopic surgery, with the implant site being the ankle joint procedure on (b)(6) 2025 when it was reported, ¿the hospital newly purchased y1301 full-suture anchor bolts.After being hammered in, the small teeth at the front end broke, making this consumable unusable.¿.Further assessment was requested and reported advised, ¿when the anchor is implanted, the front end forks and is soft, and the implanted part of the anchor body is long.During the positioning process, the direction is prone to deviation, and the front end breaks after hitting the bone." a component had fallen into the surgical site and was retrieved using forceps.The procedure was completed without any report of injury, medical intervention, or hospitalization for the patient.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: 23837067
• Report Number: 1017294-2025-00130
• Device Sequence Number: 5081126
• Product Code: MBI
• UDI-Device Identifier: 20845854021658
• UDI-Public: (01)20845854021658(17)290616(10)1393911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: Y1301
• Device Lot Number: 1393911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic