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Patient 1
THE SALES REP, ALEX WIRLO, AND THE SURGEON, DR. (B)(6), WERE CONTACTED TO COLLECT INFORMATION REGARDING THIS COMPLAINT. THE PATIENT WAS AN OLDER WOMAN WITH RELATIVELY SOFT BONE AND THERE WERE NO INJECTION ISSUES DURING THE SURGERY. DR. (B)(6) DRILLED THE SIDE DELIVERY ACCUPORT? CANNULA INTO THE PATIENT?S DISTAL FEMUR AND INJECTED THE DESIRED AMOUNT OF BONE SUBSTITUTE MATERIAL (BSM). HE THEN PLUNGED THE STYLUS INTO THE CANNULA TO FORCE THE REMAINING BSM INTO THE BONE. THE STYLUS WAS THEN REMOVED. THE SURGEON PROCEEDED TO FLEX THE KNEE TO SCOPE THE JOINT. WHEN THE SCOPING WAS COMPLETE, HE EXTENDED THE LEG AND HEARD A ?POPPING? SOUND. THE SURGEON BELIEVES THAT THE ACCUPORT? CANNULA BROKEN AT THE EXTERIOR SURFACE OF THE CORTICAL BONE, WHICH WAS ABOUT 5MM PROXIMAL TO THE 3RD FENESTRATION. THE PROVIDED C-ARM IMAGE INDICATES THAT THE INSTRUMENT BROKE AT IT'S 3RD FENESTRATION. THE SURGEON EVALUATED THE SITUATION AND DETERMINED THAT IT WOULD BE MORE DETRIMENTAL TO THE PATIENT TO TRY TO RETRIEVE THE BROKEN TIP. THE SURGEON CHOSE TO LEAVE THE PIECE IN THE PATIENT?S BODY. AS THE PART WAS NOT RETURNED, AND THE INVESTIGATOR WAS NOT AT THE SURGERY TO OBSERVE, THE DEFINITIVE CAUSE OF THIS FAILURE CANNOT BE DETERMINED. IT IS LIKELY THAT THE LACK OF STYLUS AND THE FLEXING OF THE KNEE CONTRIBUTED TO THE INSTRUMENT?S FAILURE.