MINOS MEDIUM BUR GUARD
Received Feb 14, 2008
Report 1017294-2008-00108 · MDR key 1001068
Device
Product problems
- Heat
- Replace
- Smoking
Patient
NK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD IN ORAL SURGERY, IT STARTED TO SMOKE AND BECAME HOT TO THE TOUCH. THE SURGEON REPLACED THE HANDPIECE AND BUR GUARD WITH AN ALTERNATE AND COMPLETED THE PROCEDURE WITHOUT INJURY OR SURGICAL DELAY.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE BUR GUARD FOR EVALUATION AND CONFIRMED OVERHEATING RELATED TO BEARING ASSEMBLY FAILURE. A REVIEW OF REPAIR HISTORY RECORDS SHOW THAT THIS BUR GUARD WAS LAST REPAIRED IN 2005. THE INSTRUCTION MANUAL INFORMS THE USER TO INSPECT AND OPERATE THIS DEVICE FOR PROPER FUNCTION PRIOR TO USE. THE FOLLOWING WARNING IS PROVIDED IN THE MANUAL: DO NOT USE AIR DRILL WITHOUT THE PROPER BUR GUARD. ALSO, BE SURE THE ATTACHMENT IS PROPERLY LUBRICATED AND THE BEARING IS FUNCTIONING. FROZEN BEARINGS WILL CAUSE HEAT BUILD-UP AND POSSIBLE BURNS. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFO REGARDING THIS DEVICE.