E9000 FLUTED LOW SPEED OPTIMUM BUR, ROUND
Received Feb 1, 2008 · Event occurred Jan 4, 2008
Report 1017294-2008-00091 · MDR key 991376
Device
Product problems
- Detachment Of Device Component
- Replace
- Device, removal of (non-implant)
Patient
NK
- Foreign body, removal of
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR IN A MASTOIDECTOMY PROCEDURE, THE HEAD OF THIS BUR DETACHED FROM THE SHAFT. THE SURGEON RETRIEVED THE BUR FROM THE BONE AND CONTINUED SURGERY USING ANOTHER BUR. THE USER REPORTED THAT THIS EVENT OCCURRED A SECOND TIME RESULTING IN USE OF A THIRD BUR. FOLLOWING THE SURGEON COMPLETED THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS, AND THERE WAS NO INJURY TO THE PT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVALUATION. AT THIS TIME, AN INVESTIGATION REMAINS IN PROCESS. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. THIS DEVICE IS SOLD STERILE, SINGLE USE. A REVIEW OF THIS PRODUCT'S HISTORY FOUND NO OTHER REPORTED EVENTS FOR THIS FAILURE MODE. CONMED LINVATEC FILED TWO REPORTS FOR THIS EVENT. THE OTHER MEDWATCH REPORT NUMBER IS 1017294-2008-00093.