UNK

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 FOOT SURGERY THE AR-400 HANDPIECE GOT VERY HOT, AND THE K-WIRE DIDN'T APPEAR TO ROTATE NORMALLY AND CREATED A SORT-OF METAL "DUST" AND EVEN SMALL METAL "FLAKES". IT CLEARLY JAMMED OR OBSTRUCTEDTHE K-WIRE FROM NORMAL ROTATION. AFTER NORMAL TROUBLESHOOTING, THE SURGEON SWITCH TO ANOTHER AR-400PD, AND EVERYTHING RAN SMOOTHLY. 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.