MalfunctionHTT
FMS BARREL TORNADO BUR, 4.0 MM
Received May 8, 2008 · Event occurred May 7, 2008
Report 1221934-2008-00277 · MDR key 1045113
Device
Product problems
- Tip breakage
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE SHAVER BLADE LEFT METAL SHAVINGS IN THE PTS SHOULDER. THERE WERE NO PROBLEMS REPORTED TO THE OUTCOME OF THE PROCEDURE.
Additional Manufacturer Narrative
AT THIS POINT IN TIME DEPUY MITEK IS AWAITING RECEIPT OF THE COMPLAINT DEVICE, SO A ROOT CAUSE FAILURE CAN BE PERFORMED. WHEN THE ROOT CAUSE ANALYSIS HAS BEEN COMPLETED, THE RESULTS AND CONCLUSIONS OF THE EVAL WILL BE REFLECTED IN A FOLLOW UP REPORT.