MAUDE Adverse Event Report: CONMED LARGO 3.0MM ROUND BUR, CARBIDE, 5EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	00509322600
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
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 deviceevaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
The distributor reported on behalf of their customer that the 00509322600, 3.0mm round bur, carbide, 5ea was being used during a vertebral arch formation procedure on (b)(6) 2022 when it was reported that ¿the customer alleged that the bur broke during use.There were no debris in the patient¿s body.¿ further assessment questioning found that the device fragmented while in the sterile field and the fragment fell into the surgical site.The fragment was retrieved from the surgical site using forceps.An alternate backup bur device was used to complete the surgery and there was report of no delay to the surgery.There was report of no injury to the patient, no medical/surgical intervention was required and no extended hospitalization for the patient was required.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported customer event ¿bur broke¿ was confirmed based on photographic evidence and device evaluation.Visual examination of the returned bur, item 00509322600 found carbide bur head detached from the shaft.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 13 complaints, regarding 15 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 do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 00509322600, 3.0mm round bur, carbide, 5ea was being used during a vertebral arch formation procedure on (b)(6)2022 when it was reported that ¿the customer alleged that the bur broke during use.There were no debris in the patient¿s body.¿ further assessment questioning found that the device fragmented while in the sterile field and the fragment fell into the surgical site.The fragment was retrieved from the surgical site using forceps.An alternate backup bur device was used to complete the surgery and there was report of no delay to the surgery.There was report of no injury to the patient, no medical/surgical intervention was required and no extended hospitalization for the patient was required.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 3.0MM ROUND BUR, 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14394710
• Report Number: 1017294-2022-00058
• Device Sequence Number: 2046507
• Product Code: GFF
• UDI-Device Identifier: 20845854004255
• UDI-Public: (01)20845854004255(17)260817(10)1188664
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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 Expiration Date: 08/17/2026
• Device Catalogue Number: 00509322600
• Device Lot Number: 1188664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic