ROUND BUR, MEDIUM CARBIDE 4.0MM
Received Sep 24, 2009 · Event occurred Jul 13, 2009
Report 1017294-2009-00140 · MDR key 1506677
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
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.
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: 1017294-2009-00136, 1017294-2009-00139.