MAUDE Adverse Event Report: CONMED LARGO ULTRAPOWER BUR, ROUND END (MUSTARD) 3.2MM X 15.2MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	00702129400
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the 00702129400, ultrapower bur, round end (mustard) was being used on (b)(6) 2023 and ¿it was reported that this bur broke shortly after it was put into use¿¿.After further assessment it was found that the device did fragment and fall into the surgical site.The fragment was retrieved.The procedure was completed with an alternate backup bur.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported 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 for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Reported event of the bur breaking apart is confirmed.The device has not been returned to date, but photographic evidence has been provided.The root cause cannot be determined, however, based upon the photos, the likely cause of this event was 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.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 14 reports, regarding 14 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: this equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment.Always inspect for bent, dull or damaged burs, blades or drill bits before each use.Do not attempt to straighten or sharpen.After use, dispose of properly.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 the customer that the 00702129400, ultrapower bur, round end (mustard) was being used on (b)(6) 2023 and ¿it was reported that this bur broke shortly after it was put into use¿¿.After further assessment it was found that the device did fragment and fall into the surgical site.The fragment was retrieved.The procedure was completed with an alternate backup bur.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRAPOWER BUR, ROUND END (MUSTARD) 3.2MM X 15.2MM
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18058633
• Report Number: 1017294-2023-00099
• Device Sequence Number: 6628909
• Product Code: GFF
• UDI-Device Identifier: 10845854007532
• UDI-Public: (01)10845854007532(17)270919(30)1(10)1271564
• 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,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Catalogue Number: 00702129400
• Device Lot Number: 1271564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic