OVAL BUR, EXTRA LONG, CARBIDE 5.5 X 10MM
Received Aug 1, 2008 · Event occurred Jun 6, 2008
Report 1017294-2008-00282 · MDR key 1095343
Device
Generic name
Sterile Bur
Manufacturer
Conmed LinvatecModel number
NACatalog number
00509323800
Lot number
BBD54140
Product problems
- Break
Patient
NK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THIS OVAL BUR IN A SURGICAL PROCEDURE, IT BROKE INTO 3 PIECES. THE SURGEON RETRIEVED ALL PIECES WITHOUT PATIENT INJURY OR SURGICAL DELAY.
Additional Manufacturer Narrative
CONMED LINVATEC RECEIVED THE OVAL BUR WITH THE BROKEN PIECES FOR EVALUATION. A VISUAL EXAMINATION UNDER MAGNIFICATION NOTED DISCOLORATION IN THE MATERIAL. THE PRODUCT HAS BEEN SENT TO A THIRD PARTY LAB FOR FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF FURTHER ANALYSIS. A REVIEW OF PRODUCT HISTORY FOUND ONE SIMILAR REPORTED EVENT. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.