ITOTAL TIBIAL IMPACTOR TIP
Received Aug 1, 2012 · Event occurred Jul 1, 2012
Report 3004153240-2012-00061 · MDR key 2706501
Device
Generic name
Reusable Tibial Impactor Tip
Manufacturer
Conformis, Inc.Catalog number
ED-02611
Lot number
M1107
Product problems
- Break
Patient
60 YR
- No Information
Narrative
Description of Event or Problem
TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE.
Additional Manufacturer Narrative
TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. DEVICE EVAL: THE TIBIAL TRAY IMPACTOR TIP WAS RETURNED TO CONFORMIS FOR EVAL. THE REPORTED FAILURE MODE WAS CONFIRMED. THE POST THAT CONNECTS THE TIP TO THE IMPACTOR HANDLE WAS FOUND TO BE BROKEN OFF INSIDE THE IMPACTOR HANDLE. THE COMPLAINT APPEARS TO BE AN ISOLATED INCIDENT.