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

Catalog Number	00509122500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the 00509122500, round bur, medium, 2.4 mm device was used during a tooth extraction procedure on (b)(6) 2026, and ¿bur snapped during extraction¿.The procedure was completed with the use of an alternate device and a delay of two minutes.Further assessment found ¿the bur fragmented only into 2 pieces.It broke in half.1 fragment remained was retrieved from patient and the other remained in surgaritome.No other important information".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
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.H3 other text: device not yet received.
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, photographic evidence has been provided.Root cause cannot be determined, however, based upon photos; a possible cause of this event could be 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.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 four reports, regarding four 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 the following: do not use burs for plunge cutting.Injury or damage may occur.Bur guards should always be checked before use.To reduce the risk of injury, prior to surgery, spin the bur guard on a bur.If the bur guard spins freely, the bearing is still good.Otherwise, the bur guard must be sent for repair immediately.Do not use.Overheating can occur if bur guard bearings are worn or not kept clean.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the 00509122500, round bur, medium, 2.4 mm device was used during a tooth extraction procedure on (b)(6) 2026, and ¿bur snapped during extraction¿.The procedure was completed with the use of an alternate device and a delay of two minutes.Further assessment found ¿the bur fragmented only into 2 pieces.It broke in half.1 fragment remained was retrieved from patient and the other remained in surgaritome.No other important information".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.

• 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: 24365344
• Report Number: 1017294-2026-00016
• Device Sequence Number: 13129365
• Product Code: GFF
• UDI-Device Identifier: 10845854001370
• UDI-Public: (01)10845854001370(17)300806(10)1484691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 00509122500
• Device Lot Number: 1484691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic