MalfunctionHTW
CANNULATED DRILL CS 6.5, D4.4, L 220, HUDSON
Received Sep 23, 2014 · Event occurred Aug 20, 2014
Report 8043862-2014-00013 · MDR key 4226730
Device
Product problems
- Break
Patient
46 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
SURGEON WAS DRILLING FOR THE 6.5 SCREW AND ON HIS WAY OUT THE DRILL BIT SHATTERED INSIDE AROUND THE GUIDE WIRE. IT IS POSSIBLE THAT IT MAY HAVE TOUCHED ANOTHER SCREW THAT WAS ALREADY PLACED. MOST OF THE BROKEN FRAGMENTS WERE RECOVERED BUT IT IS BELIEVED THAT A FEW FRAGMENTS MAY BE LEFT BEHIND INSIDE THE PT.
Additional Manufacturer Narrative
AFTER CHECKING THE RETURNED PIECE, IT IS MOST LIKELY THAT FRAGMENTS REMAINED IN THE PT. AAP WILL SEND THE RETURNED DRILL TO AN EXTERNAL LABORATORY FOR FURTHER EVAL. WITH REGARD TO THE DRILL FAILURE STATISTICS, IT SEEMS THAT THIS IS NOT PRODUCT RELATED PROBLEM.