MAUDE Adverse Event Report: CONMED CONMED; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	00509126000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the 00509126000, round diamond bur, medium, 2 mm device was used in an unknown procedure on (b)(6) 2025, and ¿it was reported that the diamond surface of the bar had peeled off and adhered to the bone.The surface of the bur that was attached to the bone could be easily removed.There was no impact on the surgery.¿ the procedure was completed with an alternate device, and there was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A distributor reported on behalf of a customer that the 00509126000, round diamond bur, medium, 2 mm device was used in an unknown procedure on (b)(6) 2025, and ¿it was reported that the diamond surface of the bar had peeled off and adhered to the bone.The surface of the bur that was attached to the bone could be easily removed.There was no impact on the surgery.¿ the procedure was completed with an alternate device, and there was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of ¿diamond surface of the bar had peeled off and adhered to the bone.¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.A root cause cannot be determined; however, based on photographic evidence, a possible cause of this event could be that the device was the use of excessive force.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.(b)(4).We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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 ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24019119
• Report Number: 1017294-2026-00005
• Device Sequence Number: 15691505
• Product Code: GFF
• UDI-Device Identifier: 10845854007884
• UDI-Public: (01)10845854007884(17)281203(10)1355423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/16/2026

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: 00509126000
• Device Lot Number: 1355423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic