MAUDE Adverse Event Report: CONMED CONMED; instrument, manual, surgical, general use

Catalog Number	C8623
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor reported on behalf of a customer that the device, c8623, two pin passer drill tip, 15.5", was used in an acl procedure on (b)(6) 2026, and ¿during the surgery, this complaint product was fractured during use, and the fractured piece of it has remained inside of the patient¿s body.¿ the procedure was completed with a delay of about 30 minutes.There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury of a foreign body retained in the patient.
Additional Manufacturer Narrative
G3 initial awareness date: 14-aug-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
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 one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of three reports, regarding three 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 to confirm proper knee flexion angles prior to advancement; place the leg holder high on the leg to allow adequate exposure for pin exit; the trocar tip two pin passer may be advanced by drilling or impacting, while the drill tip two pin passer may be advanced by drilling only; avoid neurovascular structures when advancing the device.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: instrument, manual, surgical, general use
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED Largo; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 525 french rd; utica, NY 13502 ; +1(727)470-8358
• MDR Report Key: 50451288
• Report Number: 1017294-2026-00156
• Device Sequence Number: 9763336
• Product Code: MDM
• UDI-Device Identifier: 10845854034255
• UDI-Public: (01)10845854034255(11)160711(30)1(10)761607
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: C8623
• Device Lot Number: 761607
• 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: 09/08/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown