CODMAN SKULL TONG

Description of Event or Problem

REP REPORTS THAT THE PRODUCT FRACTURED THE PATIENTS SKULL.

Additional Manufacturer Narrative

UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT WAS NON-VERIFIABLE. EVALUATION OF THE THREE SKULL TONGS RECEIVED INDICATED THAT ONE OF THE TONGS WAS ASSEMBLED CORRECTLY. THIS TONG HAS A SPRING-LOADED POINT (SCREW) AND A SOLID POINT (SCREW) IN PLACE. THE OTHER TWO TONGS HAVE TWO SOLID POINT SCREWS (1 TONG) AND 2 SPRING LOADED SCREWS (1 TONG). IT APPEARS THAT THE INSTRUMENTS HAVE BEEN RE-ASSEMBLED INCORRECTLY. INCORRECT ASSEMBLY MAY CONTRIBUTE TO POOR INSTRUMENT FUNCTION. THESE INSTRUMENTS ARE INSPECTED DURING THE MANUFACTURING PROCESS, INCORRECT ASSEMBLY WOULD HAVE BEEN DETECTED DURING INSPECTION. THERE WERE NO METALLURGIC DEFECTS SUCH AS CORROSION ON THE METAL SURFACES. ALL SCREWS DEMONSTRATED WELL FORMED THREADS AND WERE FULLY FUNCTIONAL. THIS COMPLAINT IS ASSOCIATED WITH IMPROPER ASSEMBLY IN THE CLINICAL SETTING AND IS NOT ATTRIBUTED TO MANUFACTURING PROCESSES. CORRECTIVE ACTION IS NOT DEEMED NECESSARY BASED ON THE ANALYSIS RESULTS. TRENDS WILL BE MONITORED FOR THIS AND/OR SMALLER COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.