MalfunctionHTT
4.0MM 6 FLUTE BARREL BUR-HOLLOW, FORMULA (5BX)
Received Feb 18, 2010 · Event occurred Feb 2, 2010
Report 2648666-2010-00095 · MDR key 1625102
Device
Product problems
- Break
- Detachment Of Device Component
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DISTAL TIP OF HOUSING BROKE OFF INTO MANY PIECES INSIDE THE PT. IT WAS FURTHER REPORTED THAT SURGEON WAS ABLE TO GET ALL PIECES CLEANED OUT. CASE WAS DELAYED APPROX 5 MINUTES.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Remedial action
- Replace