TIBIAL INSERT IMPACTOR TIP
Received Aug 2, 2013 · Event occurred Jul 1, 2013
Report 3004153240-2013-00118 · MDR key 3281135
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PERIODIC REVIEW OF ITEMS REMOVED FROM ITOTAL REUSABLE INSTRUMENT TRAYS DURING REPROCESSING WAS COMPLETED. THE REVIEW SHOWED THAT TWO FEMORAL IMPACTOR HEADS HAD BROKEN.
Additional Manufacturer Narrative
PERIODIC REVIEW OF ITEMS REMOVED FROM ITOTAL REUSABLE INSTRUMENT TRAYS DURING REPROCESSING WAS COMPLETED. THE REVIEW SHOWED THAT TWO FEMORAL IMPACTOR HEADS HAD BROKEN. THE IMPACTOR HEADS WERE BROKEN AT THE POINT WHERE THEY CONNECT TO THE IMPACTOR HANDLE. A HORIZONTAL GROVE WAS PRESENT ACROSS THE CONNECTION BORE ON ONE IMPACTOR HEAD. INSPECTION OF THE AFFECTED LOT OF MATERIAL INDICATED THAT THERE WAS A SPECIFIED RADIUS MISSING AT THE BOTTOM OF THE CONNECTION POST WHERE THE FRACTURE OCCURRED.