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 NOR 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. SITE/USER DID NOT RETAIN LOT NUMBER INFORMATION. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.