STEPPED, RATCHET DRILL SLEEVE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6 THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-1510FS-7 , STEPPED, RATCHET DRILL SLEEVE, BATCH NUMBER 051702, WAS RECEIVED FOR INVESTIGATION AND UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE TIP IS HEAVILY DAMAGED (SEE EVALUATION PICTURES 4 + 5). 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 ATTACHMENT DURING USE. FURTHER THE DEVICE SHOWS SIGNS OF METAL SURFACE OXIDATION AN FADED LASER MARKS (SEE EVALUATION PICTURES 2 + 3).

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 A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICES AR-1999 (LOT: 8002346), AR-1510FS-7 (LOT: 051702) AND AR-1996CD-1 (LOT: 47322249) DID NOT WORK PROPERLY. IT WAS IMPOSSIBLE TO SCREW THE SCREW IN WITH THE SCREWDRIVER, AND THE TIP OF THE AR-1510FS-7 DID NOT GRIP THE BONE. A PICTURE OF THE DEVICE AR-1510FS-7 SHOWED THAT THE FRONT PART OF THE DEVICE IS DAMAGED/ BROKEN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (T-HANDLE WRENCH). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.