DRILL, FOR FIBERTAK DR

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION OF THE RECEIVED AR-3657 WITH BATCH 10491659 NOTED THAT THE CUTTING-EDGE TIP IS BROKEN OFF (SEE EVALUATION PICTURES 3 + 4). NO BROKEN PIECES WERE RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE ROTATOR CUFF SPEEDFIX SURGERY, THE TIP OF THE DRILL BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.