Description of Event or Problem · 1
PATIENT IN SURGERY FOR FIRST, SECOND AND THIRD METATARSOCUNEIFORM JOINT FUSION RIGHT FOOT. APPROXIMATELY 2 CM. PIECE OF SCREW SET GUIDEWIRE BROKE OFF IN BONE. SURGEONS CHOSE NOT TO REMOVE RETAINED GUIDEWIRE. FOLLOW UP PHONE CALL TO PATIENT INDICATED NO COMPLAINTS FROM PATIENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER 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: NONE OR UNKNOWN, GUIDEWIRE. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.