ROUND BUR, MEDIUM CARBIDE 4.0 MM
Received Sep 24, 2009 · Event occurred Jul 13, 2009
Report 1017294-2009-00136 · MDR key 1506675
Device
Generic name
Bur, Orthopedic
Manufacturer
Conmed LinvatecModel number
NACatalog number
00509122800
Lot number
BBD41507
Product problems
- Break
Patient
35 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION FOR THIS DEVICE REMAINS IN PROCESS. IN ADDITION, CONMED LINVATEC IS AWAITING ADDITIONAL INFO FROM THE USER FACILITY REGARDING THIS EVENT. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. ASSOCIATED REPORTS FOR ONE SURGERY: 1017294-2009-00139, 1017294-2009-00140.
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING A TROCHLEOPLASTY PROCEDURE, THIS BUR BROKE DURING USE WITH ONE OF THE MFR'S HANDPIECES. THE SURGEON RETRIEVED ALL THE BROKEN PIECES OF BUR WITHOUT PT INJURY. THIS EVENT RESULTED IN A TEN MINUTE SURGICAL DELAY.