2.5 MM FEMALE HEX SCREW 25 MM LENGTH
Received Jun 19, 2023 · Event occurred May 26, 2023
Report 0001822565-2023-01590 · MDR key 17154125
Device
Generic name
Instrument, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
42509902525
Lot number
65766831
Product problems
- Fracture
- Fracture
Patient
Prefer Not To Disclose
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING REMOVAL, THE HEAD OF THE HEXAGONAL FEMALE WAS DAMAGED AND COULD NOT BE REMOVED. IT REMAINED IN THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.