MAUDE Adverse Event Report: CONMED Y-KNOT; orthopedic manual surgical instrument

Catalog Number	Y-BP28
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf of their customer that the device, y-bp28, y-knot rc broaching punch, 2.8 mm, was used during a rcr procedure on (b)(6) 2026 when it was reported, ¿during surgery, while the punch was being struck with a mallet, the tip of the punch broke off and became embedded in the bone.The complaint device was disposed of by the hospital and is therefore not available for return.The procedure was successfully completed using a replacement device y-bp28.No adverse impact on the patient was reported.¿.There was no report of medical intervention or hospitalization for the patient.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
G3 initial awareness date was 8/5/26.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.

• Brand Name: Y-KNOT
• Common Device Name: orthopedic manual surgical instrument
• 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 ; 525 french rd.; utica, NY 13502 ; +1(727)399-5358
• MDR Report Key: 50450534
• Report Number: 1017294-2026-00157
• Device Sequence Number: 9780298
• Product Code: LXH
• UDI-Device Identifier: 10845854040683
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/29/2026

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: Y-BP28
• Device Lot Number: 1334281
• 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: 08/27/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male