PERIOSTEAL ELEVATOR 14MM WIDTH STRAIGHT BLADE 200MM HANDL

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #-03.100.043 LOT #-5632646 MANUFACTURING DATE: 16-OCT-2007, REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE, MATERIAL, COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS, CERTIFICATION. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CTQ FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 15-OCT-2007. NO NCRS WERE GENERATED DURING PRODUCTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INITIAL OPEN REDUCTION INTERNAL FIXATION DISTAL TIBIA SURGERY ON (B)(6) 2016, THE HANDLE OF THE PERIOSTEAL ELEVATOR SPLIT OR CRACKED AND CAME OFF OF THE SHAFT AND BROKE DURING THE ELEVATION PROCESS. THE SURGEON USED ANOTHER DEVICE THAT WAS ON-HAND AND COMPLETED THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF DELAY OR MEDICAL INTERVENTION. THE PATIENT'S POST-OPERATIVE STATUS WAS NOTED TO BE STABLE. NO DEVICES WERE IMPLANTED. HE HAS NO PATIENT INFORMATION. THE DEVICE WILL REMAIN WITH THE HOSPITAL AND WILL NOT BE SENT BACK TO SYNTHES. THIS COMPLAINT HAS 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).