inforMED
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

Generic name

Drill Bit

Manufacturer

Aap Implantate Ag

Catalog number

430654

Lot number

QR0001

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.