Description of Event or Problem · 1
DURING A NON-UNION LEFT TIBIA FRACTURE REPAIR BONE GRAFT PORTION OF THE PROCEDURE, THE RESIDENT WAS USING THE TIBIAL REAMER, AND THE REAMER TIP BROKE OFF OF THE COIL. THE PARTS WERE REMOVED FROM THE PATIENT AND ANOTHER REAMER WAS SELECTED, WHICH ALSO BROKE. THE DOCTORS WERE ABLE TO GET ENOUGH BONE BEFORE THE SECOND REAMER BROKE, SO THEY WERE ABLE TO FINISH THE PROCEDURE. THE CANAL WAS IRRIGATED COPIOUSLY TO REMOVE ANY SMALL PARTICLES OF REAMER THAT MAY HAVE FALLEN OFF DURING BREAKAGE. UNFORTUNATELY, THE SURGICAL TECHS DID NOT SAVE THE REAMER TIPS, BUT INSTEAD THREW THEM INTO THE SHARPS CONTAINER. WHEN THE SPD TECH WENT TO RETRIEVE THE TIPS, SHE FOUND THAT ENVIRONMENTAL SERVICES HAD ALREADY REMOVED THE SHARPS CONTAINER AND TRANSPORTED IT OUT FOR INCINERATION. SO THE TIPS COULD NOT BE RETRIEVED AND SENT OUT FOR INSPECTION. AS PER THE ORTHOPEDIC FACULTY SURGEON, HE STATED THAT THIS PATIENT HAD A VERY STRONG BONE THAT THE REAMED GOT STUCK IN HIS BONE MEDULLA AND THEN THE WEAK POINT IN THE SYSTEM WAS THE CONNECTION BETWEEN THE REAMER AND THE REAMER HEAD. THIS HAPPENED TWICE IN THE SAME EXACT SPOT. BY ANY MEANS THIS SHOULD NOT HAPPEN. I WOULD RECOMMEND THAT WE CONTACT THE FDA TO DO TESTS ON THE CURRENT REAMERS TO SEE AT WHAT POINT DO THEY FAIL AND IF THE BONE CAN BE HARDER THAN THAT POINT. THEY MAY NEED TO RECALL THE REAMER FROM THE MARKET IF THEY FIND IT IS A MAJOR DEFECT. THE COMPANY SYNTHES REP HAS BEEN INFORMED.