TIBIAL INSERT IMPACTOR TIP
Received Aug 14, 2013 · Event occurred Jul 1, 2013
Report 3004153240-2013-00120 · MDR key 3349869
Device
Product problems
- Break
- Sticking
Patient
56 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE REUSABLE TIBIAL INSERT IMPACTOR TIP BROKE WHILE IMPACTING THE POLY INSERT. THE CONNECTION POST BROKE OFF AND BECAME STUCK INSIDE THE REUSABLE IMPACTOR HANDLE. THE SURGEON IMPACTED THE FEMORAL COMPONENT BY IMPACTING THE FEMORAL IMPACTOR TIP DIRECTLY. SURGERY WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE REUSABLE TIBIAL INSERT IMPACTOR TIP BROKE WHILE IMPACTING THE POLY INSERT. THE CONNECTION POST BROKE OFF AND BECAME STUCK INSIDE THE REUSABLE IMPACTOR HANDLE. THE SURGEON IMPACTED THE FEMORAL COMPONENT BY IMPACTING THE FEMORAL IMPACTOR TIP DIRECTLY. SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT INDICATE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.