Description of Event or Problem · 0
THE STERNALOCK EZ PLATES ARE USED IN CARDIOTHORACIC SURGERY FOR CLOSING AND STABILIZING THE STERNUM AFTER IT HAS BEEN OPENED OR FRACTURED. THE SYSTEM PROVIDES RIGID FIXATION, HELPING THE STERNUM HEAL PROPERLY AND REDUCING COMPLICATIONS SUCH AS INSTABILITY, NONUNION, OR INFECTION. WE HAVE EXPERIENCED ONGOING ISSUES WITH THE STERNALOCK EZ STERNAL PLATES THAT WERE FIRST IDENTIFIED AFTER THE HEART TEAM REPORTED MULTIPLE DEFECTS RELATED TO RUST OBSERVED IN THE BOTTOM OF THE STERILIZATION CASKETS. IN RESPONSE, OUR TEAM BEGAN INSPECTING (¿POPPING¿) THE PANS AND DISCOVERED THAT MULTIPLE INSTRUMENTS ACROSS ALL PANS EXHIBITED VISIBLE PITTING, WHICH WAS INITIALLY BELIEVED TO BE THE SOURCE OF THE RUST. THE VENDOR WAS CONTACTED AND PROMPTLY REPLACED ALL AFFECTED INSTRUMENTS. HOWEVER, DESPITE REPLACING THE INSTRUMENTS, RUST CONTINUED TO APPEAR IN THE BOTTOMS OF THE CASKETS, AND THE NEWLY SUPPLIED INSTRUMENTS ALSO DEMONSTRATED THE SAME PITTING. AS A PRECAUTION, USE OF THE STERNALOCK EZ PLATES WAS HALTED WHILE FURTHER INVESTIGATION WAS CONDUCTED. OVER THE COURSE OF SEVERAL WEEKS, WE COLLABORATED CLOSELY WITH THE VENDOR REPRESENTATIVE TO DETERMINE THE CAUSE OF THE ISSUE. MULTIPLE CORRECTIVE EFFORTS WERE ATTEMPTED, INCLUDING REPROCESSING THE TRAYS USING DIFFERENT STERILIZATION METHODS, REPLACING OUTER TRAYS, ADDING TRAYS TO CASKETS, REMOVING INSTRUMENTS FROM THE TRAY, AND FULLY REPLACING ALL INSTRUMENTS. DESPITE THESE EFFORTS, THE ISSUE PERSISTED. THE VENDOR SUBSEQUENTLY SENT ENGINEERS TO THE DEPARTMENT TO DIRECTLY OBSERVE OUR REPROCESSING WORKFLOW. TO RULE OUT ISSUES RELATED TO STERILE PROCESSING DEPARTMENT (SPD) EQUIPMENT OR PRACTICES, WE STERILIZED OTHER INSTRUMENTS USING THE SAME PROCESSES. THE ISSUE COULD NOT BE REPLICATED WITH ANY OTHER INSTRUMENT SETS, INDICATING THAT THE CONCERN APPEARS SPECIFIC TO THE STERNALOCK EZ SYSTEM. WE BELIEVE THIS ISSUE POSES A POTENTIAL PATIENT SAFETY RISK. GIVEN THE PERSISTENCE OF RUST AND PITTING DESPITE INSTRUMENT REPLACEMENT AND VERIFIED REPROCESSING PRACTICES, WE BELIEVE THIS CONCERN MAY EXTEND BEYOND OUR FACILITY. WE FEEL THESE IMPLANTS REPRESENT A BROADER SAFETY CONCERN THAT WARRANTS EXTERNAL REPORTING AND INVESTIGATION.