STERLING OVAL BUR, 5.0MM
Received Jun 11, 2009 · Event occurred May 18, 2009
Report 1017294-2009-00087 · MDR key 1401693
Device
Generic name
Burr, Orthopedic
Manufacturer
Conmed LinvatecModel number
NACatalog number
H9103RH
Lot number
BBF36339
Product problems
- Heat
Patient
65 YR
- Surgery, prolonged
- Surgical procedure
- Burn, Thermal
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING USE OF THIS SHAVER BUR WITH SHAVER HANDPIECE, THE PATIENT RECEIVED A BURN. THE BURN WAS DESCRIBED AS "MONUMENTAL". IN ADDITION, THE USER REPORTED THAT THE HANDPIECE WAS IN USE FOR ABOUT 40 MINUTES WITHOUT ANY PROBLEM. UPON CHANGING THE SHAVER BLADE, THE HANDPIECE AND BLADE GOT HOT AND BURNED THE PATIENT. THIS EVENT CAUSED A 25 MINUTES DELAY. ADDITIONAL INFORMATION RECEIVED ON JUNE 2, 2009 REPORTED THAT THE BURN REQUIRED SURGICAL INTERVENTION, WHICH WAS PERFORMED FOLLOWING THE SCHEDULED SURGERY. AT THIS TIME, THE STATUS OF THE PATIENT IS NOT KNOWN.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: AN INVESTIGATION CANNOT BE COMPLETED ON THIS DEVICE, AS IT WAS DISCARDED AT THE USER FACILITY. CONMED LINVATEC IS AWAITING RETURN OF THE SHAVER HANDPIECE TO PERFORM AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED WITH THIS INFORMATION. ASSOCIATED MDR # 1017294-2009-00081.