DRILL, 2.75MM, .066 CANNULATION

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-700-14, DRILL, 2.75MM, .066 CANNULATION, BATCH NUMBER 022537, WAS RECEIVED FOR INVESTIGATION AND UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE TEETHS ON THE TIP ARE SLIGHTLY BEND (SEE EVALUATION PICTURES 3 + 4). FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER USE / DEVICE HANDLING.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE LATARJET SURGERY, THE CANNULATED DRILL PREVENTED THE K-WIRE FROM BEING INSERTED THROUGH IT. 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.