MalfunctionHTW
AAP DRILL BIT
Received Oct 7, 2014
Report 8043862-2014-00015 · MDR key 4172162
Device
Product problems
- Break
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
DRILL BIT BROKE DURING SURGERY. NO INFO HAS FORWARDED IF PARTS OF THE DRILL BIT REMAINED IN THE PT.
Additional Manufacturer Narrative
THE DRILL BIT BROKE NEARLY AT THE END OF THE SPIRAL. THE DRILL BIT WILL BE SENT TO AN EXTERNAL LAB TO ELIMINATE ANY DOUBTS RELATED TO THE MATERIAL AND THE PRODUCTION PROCESS. PROBABLY THE REASON FOR THE FAILURE IS THAT THE PRODUCT HAS BEEN USED OVER YEARS.