MAUDE Adverse Event Report: CONMED LARGO 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	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Conmed japan reported on behalf of their customer that the device yp1301rw, y-knot pro flex 1.3 mm anchor was being used on (b)(6) 2025 and ¿used in abr.When using the second yknot, the tip of the inserter broke (one of the u-shaped parts).There was no problem with the usage procedure, but the assistant experienced difficulty drilling just before reaching the specified depth.The same problem occurred when inserting the implant.After hammering the inserter forcefully, the tip was found to be broken.X-rays confirmed that the broken fragment was embedded in the bone tunnel, and the patient was placed under observation.¿ the procedure was completed without an alternate device.This report is being raised due to the reported injury of fragmentation of the device embedded in bone tunnel.
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.A two-year review of complaint history revealed there has been a total of 4 reports, regarding 4 devices, for this device family and failure mode.During this same time frame 127,115 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 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 LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 22825916
• Report Number: 1017294-2025-00097
• Device Sequence Number: 17284290
• Product Code: MBI
• UDI-Device Identifier: 20845854649036
• UDI-Public: (01)20845854649036(17)281004(10)1346505
• 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
• Report Date (Section B): 08/18/2025

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: 1346505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic