D
Patient 1
WHILE TIGHTENING THE BLADE IN PLACE, THE HEAD OF THE SCREW BROKE OFF AND DROPPED INTO THE OPERATIVE SITE. THE SCREW WAS RETRIEVED WITH NO SEQUELAE TO THE PATIENT. THE SCREW BROKE WITH 3.2 MM FROM THE DISTAL END. THE BREAK APPEARS TO BE DUE TO WEAR AND TEAR.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, DESIGN - INADEQUATE, DESIGN - HUMAN FACTORS. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.