MalfunctionHSH
ITOTAL TIBIAL TRAY IMPACTOR TIP
Received Apr 18, 2013 · Event occurred Mar 1, 2013
Report 3004153240-2013-00072 · MDR key 3089592
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE UPON IMPACTION OF THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO KNOWN ADVERSE IMPACT TO THE PT.
Additional Manufacturer Narrative
THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE UPON IMPACTION OF THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO KNOWN ADVERSE IMPACT TO THE PT. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT INDICATE THAT THE DEVICE WAS MFG TO SPECIFICATION.