ORTHOSORB LS STRAIGHT PIN KIT
Received Mar 30, 2018 · Event occurred Feb 16, 2018
Report 0001825034-2018-02274 · MDR key 7387072
Device
Generic name
Knee Instrument
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
110010741
Lot number
848720
Product problems
- Component Missing
- Component Missing
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. ORTHOSORB KIT COMPONENTS WERE RETURNED FOR EVALUATION WITHOUT THE PACKAGING (TRAY) OF THE KIT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. WITHOUT THE OPPORTUNITY TO EXAMINE THE PACKAGING OF THE COMPLAINT PRODUCT, THE COMPLAINT CANNOT BE CONFIRMED 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.
Additional Manufacturer Narrative
(B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ORTHOSORB MISSING FROM THE STERILE PACKAGE.