PATELLA REAMER BLADE WITH PILOT HOLE 51 MM DIAMETER
Received Mar 17, 2017
Report 0001822565-2017-01779 · MDR key 6414653
Device
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.
Additional Manufacturer Narrative
(B)(4). MEDICAL PRODUCT- PATELLA REAMING SURFACE GUIDE, 51MM DIAMETER CATALOG# 00512007151 LOT# 63340333, PATELLA REAMER CLAMP CATALOG# 00512007000 LOT# 63488642, PATELLA REAMER WITH PILOT DRILL, 51 MM (DRIVE UNIT) CATALOG# 00597907751 LOT# 60007574. CUSTOMER HAS INDICATED THAT PRODUCT WILL BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT IS REPORTED THAT DURING A KNEE ARTHROPLASTY PROCEDURE THAT THE DEVICE SEIZED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.