MalfunctionHTW
MANUAL ORHOPEDIC SURGICAL INSTRUMENT
Received Jun 12, 2008 · Event occurred May 14, 2008
Report 1030489-2008-00270 · MDR key 1060840
Device
Generic name
Rail Cutter Bit
Manufacturer
Warsaw Orthopedic Inc.Model number
NACatalog number
6971111
Lot number
NG06A001
Product problems
- Break
Patient
51 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE RAIL CUTTER BIT WAS BROKEN OFF INSIDE THE VERTEBRAL BODY. THE BROKEN PIECE WAS RETRIEVED AND THE SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS. NO PATIENT COMPLICATIONS WERE REPORTED.