OPTIMESH DEPLOYABLE GRAFTING SYSTEM

Description of Event or Problem

SPINEOLOGY OPTIMESH DEPLOYABLE GRAFTING SYSTEM - THIS ITEM HAS A ONE-TIME USE METAL INSERTER THAT DEPLOYS THE OPTIMESH. THIS METAL INSERTER DOES NOT ALWAYS AUTOMATICALLY DISCONNECT. IT IS METAL AND HAS NO INDICATION OR LABELING THAT IT IS ONE-TIME USE. A REVIEW OF THEIR IFU ALSO SHOWED NO INDICATION THAT THE METAL INSERTER IS A ONE-TIME USE ITEM AND SHOULD BE DISCARDED AFTER DEPLOYMENT. AN OPTIMESH TRAY CAME INTO OUR FACILITY AND WAS PROCESSED VIA OUR STERILE PROCESSING DEPARTMENT. IT WAS COMPLETELY REPROCESSED WITH THE METAL TIP ATTACHED. THE METAL TIP WAS DETECTED IN THE OPERATING ROOM WHEN THE SURGEON ATTEMPTED TO CONNECT THE STERILE MESH GRAFT TO THE TOOL. IT WOULD NOT CONNECT - THE VENDOR REP IN THE OPERATING ROOM RECOGNIZED THAT THE METAL TIP ON THE DEPLOYMENT DEVICE SHOULD NOT BE THERE. THIS IS NOT WELL EXPLAINED IN THE IFU FOR THIS DEVICE. PER THE VENDOR REP IN THE OPERATING ROOM, THIS "SOMETIMES HAPPENS BECAUSE THE INSERTER DOESN'T LOOK LIKE A ONE-TIME USE ITEM". THERE IS NO SYMBOL OR ANY OTHER VISUAL INDICATOR. SPINEOLOGY.