inforMED
MalfunctionHTW

TWIST DRILL D3.2, L 195, COIL 50, QUICK COUPLI

Received May 28, 2014 · Event occurred Apr 30, 2014

Report 8043862-2014-00003 · MDR key 3905742

Device

Generic name

Drill Bit

Manufacturer

Aap Implantate Ag

Model number

IU 7432-00

Lot number

I032

Product problems

  • Mechanical Problem
  • Device Operates Differently Than Expected
  • Device Handling Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DRILL BIT WAS BENT DURING AND THEN BROKE. IT IS NOT KNOWN IF THE TOP OF THE DRILL WHICH BROKE OFF REMAINS IN THE BODY.

Additional Manufacturer Narrative

THE DRILL HAS BEEN RETURNED BENT AND THE TOP HAS BEEN BROKEN OFF. USUALLY A BENDING OF HARDENED MATERIAL IS NOT POSSIBLE WHEN DRILLING INTO BONE. IT SEEMS THAT THE DRILL TOUCHES EITHER ANOTHER INSTRUMENT OR AN IMPLANT HAD THE TOP BROKE OF AFTER BENDING.