JGRLOC B2B RD TI SLD DRL KIT
Received Dec 11, 2023 · Event occurred Nov 2, 2023
Report 0001825034-2023-02948 · MDR key 18303047
Device
Generic name
Tendon/ligament Bone Anchor, Non-bioabsorbable
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
110007345
Lot number
0002527892
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
NA · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(4). G2: NEW ZEALAND. 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 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE TITANIUM BUTTON OF THE IMPLANT WAS NOT SITTING FLUSH WITH BONE AFTER SUTURE TENSIONING. THE ANCHOR WAS SITTING OUT OF THE LATERAL TIBIAL CORTEX/MEDIAL FIBULAR SPACE. THE TITANIUM BUTTON AND SUTURE REMAINED WITHIN THE PATIENT BUT WERE NOT SERVING THEIR INTENDED PURPOSE. THEREFORE, ANOTHER ANCHOR WAS PLACED DISTALLY TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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.