MalfunctionHTW
TWIST DRILL D2.7, L 150, COIL 50, QUICK COUPLI
Received May 28, 2014 · Event occurred Apr 30, 2014
Report 8043862-2014-00005 · MDR key 3905786
Device
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 BROKE OFF DURING SURGERY.
Additional Manufacturer Narrative
THE DRILL HAS BEEN RETURNED AND THE TOP HAS BEEN BROKEN OFF. ALL PIECES HAVE BEEN RETURNED. THE CONTROL OF THE DEVICE HISTORY FILE AND THE QUALITY CONTROL DOCUMENTATION SHOWED NO DEVIATION FROM THE SPECIFICATION. THEREFORE THE BREAKAGE OCCURRED BY ACCIDENT AS A STATISTIC FAILURE.