MAUDE Adverse Event Report: CONMED LARGO 4MM ROUND BUR, LONG, CARBIDE, 5EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	00509222800
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 00509222800, 4mm round bur, long, carbide, 5ea, was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿shortly after the customer started using this bur, it was reported that the cutting edge chipped.¿.Further assessment questioning found that is unknown if the device fragmented into the surgical site.It was also reported that "patient and user are unlikely to be harmed.".The procedure was completed with an alternate ¿backup bur¿ and it is unknown if there was a delay in the procedure.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the 00509222800, 4mm round bur, long, carbide, 5ea, was being used during an unknown procedure on 12apr23 when it was reported ¿shortly after the customer started using this bur, it was reported that the cutting edge chipped.¿.Further assessment questioning found that is unknown if the device fragmented into the surgical site.It was also reported that "patient and user are unlikely to be harmed.".The procedure was completed with an alternate ¿backup bur¿ and it is unknown if there was a delay in the procedure.There was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the device breaking is confirmed.Evaluation of the returned used device, item 00509222800 found machined bur flutes chipped.Returned product shows signs of misuse.Excessive force (load) was used during procedure.This is technique dependent device and the most likely cause of this suspected failure is user related.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 complaints, regarding 4 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 not to use burs for plunge cutting.Injury or damage may occur.Further the ifu continues, 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 for trends through the complaint system to assure patient safety.

• Brand Name: 4MM ROUND BUR, LONG, CARBIDE, 5EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16944903
• Report Number: 1017294-2023-00045
• Device Sequence Number: 6356482
• Product Code: GFF
• UDI-Device Identifier: 10845854002964
• UDI-Public: (01)10845854002964(17)270809(30)1(10)1263229
• 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): 06/19/2023

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 Model Number: 00509222800
• Device Catalogue Number: 00509222800
• Device Lot Number: 1263229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic