MalfunctionHSH
ITOTAL TIBIAL IMPACTOR TIP
Received Oct 11, 2012 · Event occurred Sep 1, 2012
Report 3004153240-2012-00085 · MDR key 2831407
Device
Product problems
- Break
Patient
75 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TRAY CONNECTS TO THE IMPACTOR HANDLE.
Additional Manufacturer Narrative
TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TRAY CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.