CHONDRO PICK, LONG

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION OF THE RECEIVED DEVICE REVEALED THE WHITE DELRIN CAP IS MISSING THE DEVICE. THE DETACHED CAP WAS NOT RETURNED ALONG WITH THE DEVICE. FURTHER FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO DAMAGE TO THE DEVICE. A MOST LIKELY CAUSE FOR THE OBSERVED CONDITION CAN BE ATTRIBUTED TO DAMAGES RESULTING FROM REPEATED USE OVER TIME (MANUFACTURED IN 2020).

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 SURGERY THE WHITE PLASTIC ON THE HANDLE OF THE DEVICE BROKE AND FELL INSIDE THE PATIENT'S JOINT. ALL PARTS WERE 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.