DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, DOB & WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART 03.111.030 / LOT 9481881. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 24.AUG.2015. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED THAT DURING BONE GRAFTING OF A CALCANEUS FOR A TARSAL METATARSAL FUSION ON (B)(6) 2017, THE INSTRUMENT USED TO CONNECT THE TREPHINE PIECE APPEAR TO BE WORN (CHIPS APPEAR ON THE CONNECTING END OF THE SHAFT FOR TREPHINE ATTACHMENT). NOTICED WHEN THE SURGICAL STAFF WAS TRYING TO DISCONNECT THE PIECE TO GET THE BONE GRAFT OUT. THERE WAS NO REPORTED SURGICAL DELAY. NO FRAGMENTS INVOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. IT IS UNKNOWN HOW LONG THE DEVICE HAD BEEN IN USE. THE DEVICE DOES NOT FUNCTION AS INTENDED BECAUSE IT IS HARD TO CONNECT AND DISCONNECT. THIS COMPLAINT INVOLVES 1 DEVICE. CONCOMITANT DEVICES REPORTED: SILICONE HANDLE QUICK COUPLING PART 03.111.012/ LOT 9763175, QUANTITY X 1. THIS REPORT IS 1 OF 1 FOR (B)(4).