Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON (B)(6) 2018, TO TREAT A LEFT FEMORAL CONDYLE INSUFFICIENCY FRACTURE, EXPIRED OSTEOCRETE® PRODUCT WAS IMPLANTED IN THE PATIENT. AFTER IMPLANTATION AND UPON RECEIPT OF CASE PAPERWORK, IT WAS NOTED BY THE MANUFACTURER THAT THE PRODUCT HAD AN EXPIRATION DATE OF 30-AUG-2018. THE SURGEON AND DISTRIBUTOR WERE MADE AWARE OF THE ISSUE AFTER THE SURGERY AND NO FURTHER ACTION WAS TAKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. THE DEVICE WAS RELEASED FOR STERILIZATION ON (B)(6) 2017. EXPIRATION DATES ARE BASED ON THE STERILE SHELF LIFE OF THE DEVICE, WHICH WAS VALIDATED FOR ONE YEAR FROM THE DATE OF STERILIZATION. HOWEVER, THE EXPIRATION DATE NOTED ON THE PRODUCT IS GEVEN AT THE TIME OF PACKAGING, WHICH WAS 13 DAYS PRIOR TO STERILIZATION. THIS IS TO ALLOW ADEQUATE TIME TO RETRIEVE EXPIRING PRODUCT FROM THE FIELD.