MalfunctionHTT
2.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA (5B
Received Mar 26, 2009 · Event occurred Feb 24, 2009
Report 2648666-2009-00057 · MDR key 1421928
Device
Product problems
- Metal Shedding Debris
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SMALL JOINT PROCEDURE, THE SHAVER WAS SET TO HIGH SPEED, AND IT SHOT A LOT OF METAL FRAGMENTS INTO THE PT'S HAND. THE FRAGMENTS WERE RETRIEVED. ANOTHER BLADE OF THE SAME LOT WAS USED TO COMPLETE SURGERY.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Remedial action
- Replace