SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID

Description of Event or Problem

DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE HANDLE BROKE ON THREE SEPARATE DEVICES WHILE DRILLING. SALES REPRESENTATIVE FOR SMITH+ NEPHEW CONFIRMED THAT THE SURGEON WAS PERFORMING A LABRAL REPAIR AND LOADED THE GUIDEWIRE INTO THE DRILL AND STARTED TO DRILL WHEN THE HANDLE BROKE. THIS HAPPENED ON TWO ADDITIONAL DEVICES. A DELAY OF OVER AN HOUR TOOK PLACE. THE REPAIR WAS COMPLETED WITH A COMPETITOR'S DRILL AND OUR SURETAC. SALES REP. WAS NOT AT THE CASE, BUT HAS SINCE INSTRUCTED THE SURGEON ON THE CORRECT USAGE OF THE SURETAC RDS SYSTEM. NO PT INJURY OR COMPLICATIONS TOOK PLACE.

Additional Manufacturer Narrative

H10: THREE RDS DRILLS WERE RETURNED FOR EVALUATION. ALL ARE BROKEN; ONE AT THE ARBOR AND THE OTHER TWO AT THE HANDLE. THE ARBOR IS MISSING FROM TWO OF THE DEVICES. THE ARBOR THAT REMAINS ATTACHED TO A PORTION OF THE HANDLE IS CRACKED AND DEFORMED. THE PLUNGERS ON TWO DEVICES ARE FROZEN WITHIN THE HANDLE. CONCLUSION: IMPROPER USE.