MAUDE Adverse Event Report: CONMED CORPORATION 4 X 8MM OVAL BUR, LONG, CARBIDE, 5EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5092-236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned used device, item 00509223600, found the bur head detached from the shaft.Critical dimensions were inspected and could not find any discrepancies with machined bur.No defects were found through measurement or examination of the returned product.It is suspected, excessive force (load) was used during procedure.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.A two-year review of complaint history revealed there has been a total of 26 complaints, regarding 35 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).The instructions for use (ifu) advises the user: not to 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
On behalf of the customer the distributor reported an issue with item 00509223600, 4 x 8mm oval bur, long, carbide, 5ea.It was reported that during surgery on (b)(6) 2018, while cutting of the screw head, the bur was broken at the joint part of head and shaft.Additional information received indicates that the broken piece was retrieved by hand with no impact to the patient.All pieces of the broken bur were removed from the patient and no patient or user injury was reported.The surgery was successfully completed using a back-up bur with no further issues and no delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4 X 8MM OVAL BUR, LONG, CARBIDE, 5EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 7915335
• Report Number: 1017294-2018-00149
• Device Sequence Number: 16518948
• Product Code: GFF
• UDI-Device Identifier: 10845854001257
• UDI-Public: (01)10845854001257(17)230503(30)1(10)929072
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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: 05/03/2023
• Device Model Number: 5092-236
• Device Catalogue Number: 00509223600
• Device Lot Number: 929072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/27/2018
• Patient Sequence Number: 1