MalfunctionHTT
4.0MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received Sep 16, 2010 · Event occurred Sep 2, 2010
Report 2648666-2010-00402 · MDR key 1847231
Device
Product problems
- Flaked
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DISTAL TIP OF THE UNIT BEGAN TO FLAKE WHILE THE SURGEON WAS PERFORMING A SUBACROMIAL DECOMPRESSION. IT WAS FURTHER REPORTED THAT THE CASE WAS DELAYED 30 MINUTES SO THAT THE SURGEON COULD RETRIEVE THE BROKEN PIECES. A NEW UNIT FROM THE SAME LOT WAS USED TO FINISH THE CASE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.