DRILL BITS

Description of Event or Problem

WHILE USING A MIDAS REX DRILL DURING A CRANIOTOMY, TWO ANSPACH C1 DRILL BITS BROKE. A THIRD DRILL BIT BROKE ON CLOSING THE SKULL. TWO OF THE BITS WERE 72.7 MM LONG AND 1.25 MM IN DIAMETER. ONE WAS BROKEN 8.25 MM FROM THE DISTAL END OF THE OTHER WAS 11.1 MM FROM THE DISTAL END. THE THIRD BIT WAS BROKEN 6.6 MM FROM THE DISTAL ENDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: END OF LIFE - PREMATURE, INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: USER ERROR 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.