DISPOSABLE REFLECTIVE MARKER SPHERES

Description of Event or Problem

THIS EVENT WAS COMMUNICATED BY CUSTOMER AT (B)(6). CUSTOMER ADVISED THAT A SPHERE FELL APART DURING ALIGNMENT OF LEG WITH NAVIGATION SYSTEM DURING A TOTAL KNEE REPLACEMENT SURGERY. THE SPHERE WAS NOT TOUCHED AND FELL APART ON IT'S OWN. CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT HARMED IN ANY WAY DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH A NEW PACKAGE OF SPHERES. CUSTOMER REPORTED THAT THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.

Additional Manufacturer Narrative

THE INITIAL SUBMISSION WAS ERRONEOUSLY SUBMITTED AS A 5 DAY REPORT. NDI WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM.