EPIFIX GROWTH CONTROL SYSTEM

Additional Manufacturer Narrative

MULTIPLE MDRS REPORTED FOR THE SAME PATIENT EVENT, SEE 3013680140-2020-00001 & 3013680140-2020-00003. DURING INVESTIGATION, ALL MANUFACTURING RECORDS WERE FOUND TO BE CONFORMING. ROOT CAUSE IDENTIFIED TO BE ENGINEERING SPECIFICATION ERROR WHICH ALLOWED MANUFACTURING VARIABILITY AND ULTIMATELY A THIN WALL CONDITION. THIS IS THE COMPANY'S FIRST COMPLAINT; WE HAVE BEEN WORKING WITH THE ESIG AND EMDR TEAMS TO GAIN ACCESS AND HAVE A SUCCESSFUL TEST SUBMISSION OVER THE PAST 2 MONTHS HENCE THE DELAY IN 30-DAY REPORTING.

Description of Event or Problem

IT WAS REPORTED THAT SCREWS PULLED THROUGH 3 OF THE EPIFIX PLATES DURING SURGERY. IT WAS REPORTED THAT THIS DID NOT AFFECT THE OUTCOME OF THE SURGERY ON THE PATIENT. NO INJURY OR DELAY OF SURGERY WAS REPORTED. 3 PLATES WERE EXPLANTED, REMAINING 4 PLATES WERE IMPLANTED SUCCESSFULLY. NO ALLEGATIONS WERE REPORTED AGAINST THE SCREWS OR INSTRUMENTS IN THE PROCEDURAL KITS. THIS IS DEVICE 2 OF 3 (SEE 3013680140-2020-00001 & 3013680140-2020-00003 FOR REMAINING DEVICES). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.