MIDAS REX 8 NAVIGATIONAL STEALTH

Description of Event or Problem

THE MEDTRONIC STEALTH DRILL (LOANER) WAS USED DURING A NEUROSURGICAL CASE. WHILE FOLLOWING STANDARD USE PROTOCOLS, THE DRILL BURR UNEXPECTEDLY DISLODGED FROM THE HANDLE, PASSING THROUGH MULTIPLE DRAPES. FORTUNATELY, THE PATIENT DID NOT SUSTAIN ANY BURNS. IOBAN WAS APPLIED TO MAINTAIN STERILITY OF THE SURGICAL FIELD. THE DRILL WAS IMMEDIATELY REMOVED FROM SERVICE AND RETRIEVED BY THE VENDOR. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE DRILL'S INTERNAL BEARINGS WERE FAILING. ADDITIONALLY, IT WAS DISCOVERED THAT THE DEVICE LACKED DOCUMENTATION OF ROUTINE PREVENTATIVE MAINTENANCE OR FUNCTIONAL TESTING BY MEDTRONIC. THE VENDOR WAS UNABLE TO PROVIDE EVIDENCE OF ANY SUCH MAINTENANCE OR TESTING ON THE LOANED DEVICE. THIS RESULTED IN THE OPERATING ROOM NO LONGER USING LOANER DRILLS FROM MEDTRONIC AND BRINGING IN LOANERS FROM ANOTHER COMPANY.