T20 HEXALOBE DRIVER

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVERS WERE HEAVILY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 14-JAN-2026: THE REPORTED DEVICES ARRIVED AT ARTHREX GMBH AND DURING AN INITIAL INSPECTION OF THE DEVICES IT WAS NOTICES THAT THE TIP OF THE DEVICE AR-8970-03 (LOT: 1392436) IS BROKEN OFF. UPDATE 27-JAN-2026: IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT AND THE DEVICE MIGHT HAVE BROKEN DURING SURGERY.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-8970-03, T20 HEXALOBE DRIVER, BATCH NUMBER 1392436, WAS RECEIVED FOR INVESTIGATION AND THE EVALUATION REVEALED THAT A PART OF THE HEXALOBE TIP IS BROKEN OFF (SEE EVALUATION PICTURES 3 + 4). FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. NO FRAGMENTS WERE RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DRIVER WHILE ENGAGED WITH THE SCREW AND/OR OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.