NEXGEN PATELLA REAMER BLADE
Received Dec 15, 2016 · Event occurred Nov 15, 2016
Report 0001822565-2016-04674 · MDR key 6178478
Device
Generic name
Knee Instrument
Manufacturer
Zimmer, Inc.Model number
N/ACatalog number
00597909532
Lot number
63417748
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. EXAMINATION OF THE RETURNED REAMER BLADE DETERMINED THAT THE BLADE EXHIBITS SCRATCHES AND GOUGES TO THE OUTER DIAMETER. DIMENSIONAL INSPECTION FOUND THAT THE INNER AND OUTER DIAMETERS WERE CONFORMING TO PRINT SPECIFICATIONS. DEVICE HISTORY RECORD REVIEW FOUND NO DISCREPANCIES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. DEVICE ANALYSIS INDICATED THAT THE DEVICE MET SPECIFICATION, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
Description of Event or Problem
IT IS REPORTED THAT DURING A KNEE ARTHROPLASTY THE REAMER BLADE WAS CATCHING IN THE REAMER GUIDE. METAL DEBRIS FROM THE INSTRUMENT HAD TO BE IRRIGATED FROM THE SURGICAL WOUND.
Additional Manufacturer Narrative
(B)(4). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem
IT IS REPORTED THAT DURING A KNEE ARTHROPLASTY THE REAMER BLADE WAS CATCHING IN THE REAMER GUIDE AND METAL DEBRIDE FROM THE INSTRUMENT HAD TO BE IRRIGATED FROM THE SURGICAL WOUND.