ACRA-CUT INC

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ALLEGING THAT THE DISPOSABLE CRANIAL PERFORATOR DID NOT STOP UPON BREAKTHROUGH DURING A NEUROSURGICAL PROCEDURE. THE USER REPORTED CONTINUED ROTATION OF THE PERFORATOR AFTER PENETRATION OF THE CRANIAL BONE. NO PATIENT INJURY, ADVERSE CLINICAL OUTCOME, OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION, DIMENSIONAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. THE DEVICE MET ALL ACCEPTANCE CRITERIA AND FUNCTIONED AS INTENDED. THE ALLEGED MALFUNCTION COULD NOT BE CONFIRMED DURING THE INVESTIGATION. THE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. ALTHOUGH NO PATIENT INJURY OCCURRED AND THE REPORTED MALFUNCTION WAS NOT CONFIRMED, THIS EVENT IS BEING SUBMITTED AS A MALFUNCTION MDR BECAUSE RECURRENCE OF THE ALLEGED EVENT COULD POTENTIALLY RESULT IN A SERIOUS INJURY.

Description of Event or Problem

THE PERFORATOR DID NOT STOP. IT WAS THE FIRST DRILL HOLE MADE WITH THE PERFORATOR. IT WAS IN THE TEMPORAL LOBE. THE DRILL BIT DIDN'T STOP AND SIMPLY FELL THROUGH THE BONE, PERFORATING THE DURA MATTER AND CAUSING A CONTUSION IN THE TEMPORAL LOBE. THE HOSPITAL REPORTED NO DEATH OR SERIOUS INJURY HAS OCCURED DUE TO THIS EVENT.