MalfunctionHTT
5.5MM 12 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received Jul 13, 2010 · Event occurred Jun 17, 2010
Report 2648666-2010-00298 · MDR key 1767629
Device
Product problems
- Material Fragmentation
Patient
UNK
- No Known Impact Or Consequence To Patient
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 SUBACROMIAL DECOMPRESSION AND THE FLAKING OCCURRED WHILE THE BED OF THE ACROMIUM WAS BEING FLATTENED.
Additional Manufacturer Narrative
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.