MalfunctionHTT
5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received Jul 13, 2010 · Event occurred Jun 17, 2010
Report 2648666-2010-00297 · MDR key 1767632
Device
Product problems
- Flaked
- Metal Shedding Debris
Patient
UNK
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT WAS FLAKING OFF METAL SHAVINGS INSIDE THE JOINT OF THE PT. IT WAS FURTHER REPORTED THAT THE CASE WAS A SUBACHROMIAL DECOMPRESSION AND THE FLAKING OCCURRED WHILE THE BED OF THE ACHROMIUM WAS BEING FLATTENED.
Additional Manufacturer Narrative
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.