MalfunctionHTW
TWIST DRILL D2, 5MM, L 110, COIL 50
Received Nov 8, 2012
Report 8043862-2012-00016 · MDR key 2865416
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DRILL BIT BROKE DURING APPLICATION.
Additional Manufacturer Narrative
THE DISTRIBUTOR OF AAP'S TWIST DRILL HAS RETURNED THE DEVICE FOR FURTHER EVALUATION. THE HARDNESS HAS BEEN CHECKED BY AN EXTERNAL LABORATORY. NO DEVIATION FROM THE SPECIFICATION HAS BEEN IDENTIFIED. ALSO NO FURTHER COMPLAINTS OF OTHER TWIST DRILLS OF THIS BATCH WERE FORWARDED TO AAP.