inforMED
MalfunctionHTW

TWIST DRILL D3.8, L 310, COIL 50, QUICK COUPLI

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

Report 8043862-2014-00004 · MDR key 3905768

Device

Generic name

Drill Bit

Manufacturer

Aap Implantate Ag

Model number

IU 7438-33

Lot number

L007

Product problems

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

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE DRILL HAS BEEN RETURNED AND THE TOP HAS BEEN BROKEN OFF. THE TOP OF THE DRILL WAS NOT RETURNED. THE SHAFT OF THE DRILL SHOWS SEVERAL DAMAGES. PROBABLY A FOREIGN BODY IN THE DRILL GUIDE CAUSED THIS DAMAGES WHICH RESULTED IN THE BREAKAGE OF THE DRILL.

Description of Event or Problem

DRILL BIT BROKE OFF DURING SURGERY. IT IS NOT KNOWN IF THE TOP OF THE DRILL WHICH BROKE OFF REMAINS IN THE BODY.