GLENOID SIZER HANDLE

Additional Manufacturer Narrative

(B)(4) G2: FOREIGN - EVENT OCCURRED IN CANADA. THE COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. THE SIZER HANDLE PLUNGER HAS FRACTURED, AND NOT ALL PIECES WERE RETURNED. A VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF USE WITH SOME NICKS AND GOUGES ON THE BLUE HANDLE OF THE DEVICE AND SOME WEAR AND TEAR ON THE SHAFT OF THE SIZER HANDLE. THE DISTAL END OF THE SIZER HANDLE BODY IS ALSO DAMAGED AND DEFORMED. FRACTURE ANALYSIS HAS BEEN PREVIOUSLY ANALYZED FOR THIS FRACTURE LOCATION WHERE OVERLOAD WAS IDENTIFIED AS THE MODE OF FAILURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

Description of Event or Problem

IT WAS REPORTED THAT AN INSTRUMENT WOULD NOT ENGAGE WITH THE GLENOID SIZER DURING SURGERY. THE CORRECT SURGICAL TECHNIQUE WAS USED, AND THERE WERE NO REPORTS OF FOREIGN BODY RETENTION, COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS DUE TO THIS MALFUNCTION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.