MalfunctionHTW
TORNIER
Received Nov 9, 2010 · Event occurred Sep 21, 2010
Report 9610667-2010-00013 · MDR key 1902206
Device
Product problems
- Break
- Detachment Of Device Component
Patient
73 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT IS REPORTED THAT DURING SURGICAL PREPARATION FOR A SHOULDER PROSTHESIS, THE DRILL BIT BROKE IN BONE. THE BROKEN TIP IS REPORTED TO REMAIN IN THE PT. THE REMAINING SEGMENT OF DRILL IS CURRENTLY AT THE CLINICAL FACILITY. RELEASE FOR EXAMINATION HAS BEEN REQUESTED. DEVICE LOT NUMBER HAS NOT BEEN REPORTED. THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY. REFERENCE USER FACILITY REPORT 0504240000-2010-8015. (B)(4).
Additional Manufacturer Narrative
THE DRILL BIT IS A CLASS 1 REUSABLE SURGICAL TOOL.