MalfunctionHSH
TIP, TIBIAL INSERT IMPACTOR
Received Jun 5, 2013 · Event occurred May 6, 2013
Report 3004153240-2013-00095 · MDR key 3179163
Device
Product problems
- Break
Patient
47 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE REUSABLE POLY INSERT IMPACTOR TIP BROKE AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT INDICATE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.