NDI PASSIVE SPHERES

Description of Event or Problem

REFLECTIVE STERILE SPHERES FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SPHERES WERE NOT RETURNED AS THE DEVICE WAS USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. SITE/USER DID NOT TAKE PICTURES OF SPHERE. THEREFORE, NO INVESTIGATION OR ANALYSIS COULD BE PERFORMED. CONTRACT MANUFACTURER EVALUATED DHR BASED ON LOT NUMBER. NO QUALITY ISSUES WERE NOTED DURING IN PROCESS INSPECTIONS. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.