MAUDE Adverse Event Report: CONMED CORPORATION 4MM ROUND BUR, EXTRA LONG, CARBIDE

Model Number	5093-228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported failure cannot be verified.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 were 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.(b)(4).Per the instructions for use, the user is advised the following: not to apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shave 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 customer reported that the 00509322800, 4mm round bur, loosened from the drill rod.The tip of the bur was retrieved from the patient.A request for additional information has been made, but no information was received to date.There is no reported injury or delay of surgery.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 4MM ROUND BUR, EXTRA LONG, CARBIDE
• Common Device Name: BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8457223
• Report Number: 1017294-2019-00037
• Device Sequence Number: 13541720
• Product Code: GFF
• UDI-Device Identifier: 10845854002490
• UDI-Public: (01)10845854002490(17)230820(30)1(10)955390
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 08/20/2023
• Device Model Number: 5093-228
• Device Catalogue Number: 00509322800
• Device Lot Number: 955390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/27/2019
• Patient Sequence Number: 1