CODMAN DISPOS PERFORATOR

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE AUTO-RELEASE FUNCTION OF A PERFORATOR (ID: 261221) WAS NOT WORKING PROPERLY. IT WAS USED WITH MR8 BY MEDTRONIC TO PERFORATE (RPM 70,000¿75,000). THE AUTO-RELEASE FUNCTION ACTIVATED AFTER SURPASSING THE BONE PAD AND OCCURRED SEVERAL TIMES. ALTHOUGH THIS EVENT DID NOT CAUSE DURAL DAMAGE, IT RESULTED IN A CONSCIOUSNESS DISORDER AND CONVULSIONS. THEREFORE, THE SURGEON ATTEMPTED TO CREATE HOLES WITH EXTRA CAUTION, BUT IT WAS TAKING TOO LONG TO PERFORATE, WHICH COULD CAUSE THERMAL DAMAGE. THE NURSE WAS POURING WATER INTO THE PERFORATED AREA, BUT THE WATER WAS NOT REACHING THE AREA EFFECTIVELY. ONLY THE 14 MM PERFORATOR FROM INTEGRA WAS AVAILABLE AT THAT TIME, AND THERE WAS NO OPTION TO SWITCH TO ANOTHER DEVICE. THE AUTO-RELEASE FUNCTION ACTIVATED AT UNEXPECTED TIMING, SO THE DOCTOR APPLIED APPROXIMATELY 40% LESS FORCE (ESPECIALLY IN THE LATTER HALF). THE ANGLE OF APPROACH WAS PERPENDICULAR, WITH NO ROCKING MOTION, AND NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE THICKNESS OF THE BONE APPEARED TO BE EVEN. THE INSPECTION OF THE DRILL WAS COMPLETED, AND THERE APPEARED TO BE NOTHING WRONG WITH THE DRILL. TIMES REQUIRED TO MAKE EACH HOLE. FIRST HOLE: APPROXIMATELY 8.5 MINUTES (70,000RPM). SECOND HOLE: APPROXIMATELY 6.5 MINUTES (75,000RPM). THIRD HOLE: APPROXIMATELY 6.5 MINUTES (75,000RPM). FOURTH HOLE: APPROXIMATELY 5.5 MINUTES (75,000RPM) * PTERIONAL. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DRILL IS ELECTRIC OR PNEUMATIC, IF THE PERFORATOR CLICKED IN PLACE IN THE DRILL, IF THE RECOMMENDED SPRING TESTS WERE PERFORMED BETWEEN EACH BURR HOLE, AND WHETHER CONSTANT DOWNWARD PRESSURE WAS APPLIED.