Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE DEVICE FAILED DURING ITS FIRST USAGE. THE CUTTING EDGE DEFORMED CREATING A LARGE BURR. ADD'L INFO WAS REC'D FROM THE SALES REP IN 2008, THAT THIS DEVICE MALFUNCTIONED WHILE BEING USED ON A PT; BUT NO PT INJURY WAS REPORTED BY THE FACILITY. THIS COMPLAINT WAS ONE OF THREE INVOLVING KERRISONS. THE NEURO-COORD ADVISED THAT THE CUTTING EDGE; THE TIPS OF THE INSTRUMENT WERE BENT BACK ON ALL THREE KERRISONS. HE SAID "IT WAS NOT EASILY SEEN WITH THE NAKED EYE, BUT UNDER MAGNIFICATION THE DEFECT COULD BE VISUALIZED. ALL THREE FAILED IN USE; AND THAT FROM HIS EXPERIENCE WAS HIGHLY UNLIKELY. IT COULD HAVE OCCURRED IN SHIPPING OR PROCESSING, BUT NO ONE NOTICED. IT WAS A SEVERE BURR. THE DEVICE WAS NOT CUTTING; THE BITE WAS NOT CLEAN; THE PHYSICIAN ACTUALLY HAD TO PULL ON THE INSTRUMENT. IT DID NOT CAUSE ANY INJURY TO THE PTS INVOLVED, BUT THESE INSTRUMENTS ARE USED IN A VERY SENSITIVE AREA. THESE DEVICES ARE USED TO CUT AROUND NERVE ROOT, AND THE DURA IN THE SPINAL CORD. THEREFORE, HE FELT THERE WAS A POTENTIAL FOR INJURY." THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN REC'D FOR EVAL AND INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTD INFO.