MalfunctionHTT
ROUND BUR, MEDIUM CARBIDE 4. 0MM
Received Jun 24, 2009 · Event occurred May 20, 2009
Report 1017294-2009-00088 · MDR key 1459113
Device
Generic name
Burr, Orthopedic
Manufacturer
Conmed LinvatecModel number
NACatalog number
00509122800
Lot number
BBD52843
Product problems
- Break
Patient
NK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
TO DATE, CONMED LINVATEC HAS NOT RECEIVED THIS BUR FOR EVALUATION. IN ADDITION, CONMED LINVATEC IS AWAITING ADDITIONAL INFO REGARDING THIS EVENT. A FOLLOW-UP REPORT WILL BE SENT UPON RECEIPT OF THE DEVICE AND COMPLETION OF AN INVESTIGATION. ASSOCIATE REPORT # 1017294-2009-00095.
Description of Event or Problem
IT WAS REPORTED THAT DURING A TROCHLEOPLASTY PROCEDURE, TWO OF THREE BURS BROKE AT THE SHAFTS AREA. THE SURGEON RETRIEVED ALL PIECES WITHOUT PT INJURY OR SURGICAL DELAY.