MalfunctionHTT
BUR, MEDIUM, TAPERED SIDE-CUTTING, CARBIDE
Received Mar 25, 2009 · Event occurred Mar 3, 2009
Report 1017294-2009-00040 · MDR key 1391975
Device
Generic name
Surgical Instrument Motor Access/attach
Manufacturer
Conmed LinvatecModel number
NACatalog number
M20T
Lot number
NK
Product problems
- Break
Patient
NK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THIS BUR IN A HAMMER TOE SURGERY, IT BROKE IN HALF. ALL PIECES OF THE BUR WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BUR, AND THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON RECEIPT OF THE DEVICE AND COMPLETION OF AN INVESTIGATION.