DISPOSABLE REFLECTIVE MARKER SPHERES

Description of Event or Problem

THIS EVENT WAS COMMUNICATED BY A CUSTOMER WHO RECEIVED A COMPLAINT FROM (B)(6). THE DESCRIPTION AS PROVIDED BY THE INITIAL COMPLAINANT TO OUR CUSTOMER IS AS FOLLOWS: "THE DEFECTIVE SPHERES SEEM TO HAVE HALF OF THE REFLECTIVE COATING LAYER SOMEWHAT UNWRAPPED FROM THE SPHERE UPON OPENING. THAT IS, THERE IS AN OPEN SEAM BETWEEN THE TWO HEMISPHERES OF REFLECTIVE WRAPPING" FURTHER FOLLOW-UP WITH THE INITIAL COMPLAINANT INDICATES THAT WHEN THE SPHERES WERE SCREWED ON TO THE ARRAY, THEY SPLIT DOWN THE MIDDLE, EVEN WITHOUT MUCH FORCE AND THE TWO HEMISPHERES SEPARATED. INITIAL COMPLAINANT STATED THIS HAPPENED PRIOR TO AND DURING SURGERY. INITIAL COMPLAINANT CONFIRMED NO PATIENT INJURY OR OTHER SERIOUS HARM OCCURRED AND NO SERIOUS DETERIORATION TO PATIENT HEALTH. PROCEDURE WAS COMPLETED WITH A NEW PACKAGE OF SPHERES.