MalfunctionHTT
4.0MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received Mar 3, 2010 · Event occurred Feb 18, 2010
Report 2648666-2010-00119 · MDR key 1628673
Device
Product problems
- Flaked
- Device Or Device Fragments Location Unknown
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT 3 OF THE 5 BLADES FROM ONE BOX FLAKED WHILE IN THE PT. IT WAS NOT CONFIRMED THAT ALL PIECES OF THE BLADE WERE ABLE TO BE REMOVED FROM THE PT.
Additional Manufacturer Narrative
ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.