4MM D.D. TAPERED BURR

Description of Event or Problem

WHILE THE PHYSICIAN WAS DOING AN ARTHRODESIS OF THE LEFT ANKLE HE BEGAN TO USE THE BURR ON THE TALAR AND TIBIAL SURFACES, IN PREPARATION FOR THE FIXATION. THE BURR WHEN IT HIT HARD BONE WOULD SLOW DOWN. IN CONTINUING TOUSE THE BURR THE PHYSICIAN NOTED A HARD AREA AND EVENTUALLY THE APPARATUS STOPPED AND IT WOULD NOT START. HE CHECKED THE CONNECTION, FELT THAT IT COULD HAVE POSSIBLY BEEN LOOSE, AND HE TRIED TO START THE BURR AGAIN. IT WOULD NOT WORK. HE CHECKED THE CONNECTION AGAIN AND THEN LOOKED AT THE BURR AND STEM IN THE ANKLE. AHEMOSTAT WAS USED TO REMOVE THE BURR AND THE STEM AND THERE WAS NO ADVERSE OUTCOME TO PATIENTDEVICE LABELED FOR SINGLE USE. 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.