NEXGEN PATELLA REAMER BLADE WITH PILOT HOLE
Received Oct 31, 2016 · Event occurred Oct 10, 2016
Report 0001822565-2016-03802 · MDR key 6066178
Device
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
82 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.
Description of Event or Problem
IT IS REPORTED THAT THE PATELLA REAMER BLADE MALFUNCTIONED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EXAMINATION OF THE RETURNED PATELLA REAMER BLADE AS RETURNED FOUND THE REAMER BLADE EXHIBITS SCRATCHES ON THE OUTER SURFACE. THE RETURNED BLADE PASSED FUNCTIONAL TESTING FOR SLOT LOCATION ANGLE OF PATELLA REAMER AND RING SLOT POSITION. DIMENSIONAL INSPECTION FOUND THAT THE INNER AND OUTER DIAMETERS WERE CONFORMING TO PRINT SPECIFICATIONS. DEVICE HISTORY RECORD WAS REVIEWED WITH NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.