PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

6.0MM REAMER BROKE DURING REAMING INTO FOUR PIECES WHILE REAMING. ALL PIECES WERE ABLE TO BE RECOVERED FROM THE CANAL AS THEY STAYED ON THE GUIDE WIRE.

Additional Manufacturer Narrative

THE INVESTIGATION IS PENDING FURTHER INFORMATION.

Description of Event or Problem

6.0MM REAMER BROKE DURING REAMING INTO FOUR PIECES WHILE REAMING. ALL PIECES WERE ABLE TO BE RECOVERED FROM THE CANAL AS THEY STAYED ON THE GUIDE WIRE.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION. MEDICAL OVERSIGHT REVIEW: A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD ON JULY 18, 2024, WHERE THE X-RAY, IMAGES AND CASE INFORMATION WAS REVIEWED, SEE ATTACHMENT C. THE MEDICAL REVIEWER STATED THAT WHILE TRYING TO FIX A PROXIMAL TIBIA FRACTURE, THE 2.0MM BALL-TIPPED GUIDEWIRE WAS POSITIONED UP AGAINST A CEMENT PEG (BELOW THE KNEE PROSTHESIS). AS THE GUIDEWIRE AND REAMER WERE PUSHED THERE IS FORWARD PRESSURE CAUSING IT TO BEND AND COMPRESS AND THEN BREAK. IN A FOLLOW-UP EMAIL BY THE MEDICAL REVIEWER HE STATED THAT "LOOKING EVEN MORE CLOSELY AT THIS FLUORO SHOT, IT LOOKS LIKE THEY WERE USING AN INSTRUMENT TO LEVER UP THE MEDIAL TIBIAL PLATEAU. I WOULD OFFER THAT THE REAMER MAY HAVE CAUGHT THAT AND BOUND UP IN ADDITION TO CATCHING THE CEMENT FOR THE TKA HEEL." DHR REVIEW: THE DHR FOR LOT 430672 WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE, SEE ATTACHMENT B. THERE IS NO INDICATION THE MANUFACTURE OF THE DEVICE CONTRIBUTED TO THIS FAILURE. RETURNED PRODUCT EVALUATION: THE DEVICE WAS DECONTAMINATED AND PHOTO DOCUMENTED. THE DEVICE WAS BROKEN INTO 4 PIECES (3 SMALL DISTAL PIECES AND ONE LONGER PROXIMAL PIECE). EACH PIECE WAS CLEANLY BROKEN ALONG A KERF. THE CUTTING HEAD HAD SEVERAL ABRASIONS/SCRATCHES VISIBLE ON IT. THE DAMAGE VISIBLE TO THE CUTTING HEAD SUPPORTS THE HYPOTHESIS MADE BY THE MEDICAL REVIEWER THAT THE REAMER MAY HAVE BEEN CAUGHT IN THE INSTRUMENT USED TO LEVER UP THE MEDIAL TIBIAL PLATEAU OR THE CEMENT FOR THE TKA HEEL, RESULTING IN THE REAMER OVER TORQUING AS THE DISTAL CUTTING HEAD COULD NOT ROTATE. THE SIGNIFICANT SCRATCHES VISIBLE IN THE CUTTING HEAD SUGGEST THE DEVICE ENGAGED WITH A HARD, LIKELY METALLIC MATERIAL, MOST LIKELY THE INSTRUMENT USED TO LEVER UP THE MEDIAL TIBIAL PLATEAU. THE CLEAN BREAK ALONG THE KERFS SUGGESTS A FAST BREAK, AS A SLOWER BREAK WOULD USUALLY RESULT IN VISIBLE TIGHTENING OR UNWINDING OF THE KERFS, WHICH WERE NOT PRESENT IN THIS DEVICE. IFU REVIEW/POTENTIAL FOR USER ERROR: THE MEDICAL OVERSIGHT REVIEW AND RETURNED PRODUCT EVALUATION INDICATE THAT THE REAMER CUTTING HEAD BECAME CAUGHT ON AN INSTRUMENT OR CEMENT FOR THE TKA, CAUSING THE REAMER TO BREAK WHEN OVER TORQUED. THE REAMERS ARE DESIGNED TO CLEAR THE CANAL AS PART OF THE CANAL PREPARATION STEPS AND ARE NOT DESIGNED TO BE USED WITH THE CUTTING HEAD IN CONTACT WITH ANOTHER METAL INSTRUMENT OR BONE CEMENT. THE TIBIA SURGICAL TECHNIQUE GUIDE 900611_C STATES "THE REAMERS ARE USED TO ACHIEVE A MINIMUM DIAMETER OF 8.0MM PATHWAY INTO THE CANAL TO ALLOW FOR THE DELIVERY OF THE INTRODUCER SHEATH OF 7.0MM." THE STG ALSO STATES THAT FLUOROSCOPIC IMAGING SHOULD BE USED TO ENSURE VISUALIZATION OF THE CANAL AND ASSOCIATED ANATOMY. THE IFU 900356_X ALSO STATES, PRECAUTIONS: STRICT ADHERENCE TO GOOD SURGICAL PRINCIPLES AND TECHNIQUES ARE REQUIRED DURING THE USE OF THE ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM, AND USE OF AN ILLUMINOSS REAMER SUCH THAT THE CUTTING HEAD MAY CONTACT ANOTHER METAL INSTRUMENT OR BONE CEMENT IS NOT GOOD SURGICAL TECHNIQUE, AND USER ERROR CAUSES THIS COMPLAINT. CONCLUSION: THE FLEXIBLE REAMER BROKE DURING USE BECAUSE THE CUTTING HEAD BECAME BOUND IN MOST LIKELY ANOTHER METAL SURGICAL INSTRUMENT USED TO LEVER UP THE MEDIAL TIBIAL PLATEAU OR POTENTIALLY THE CEMENT OF THE TKA. AS THE CUTTING HEAD WAS CAUGHT AND COULD NOT ROTATE, AND THE USER ATTEMPTED TO TURN THE REAMER, THE SHAFT BECAME OVER TORQUED AND BROKE (USER ERROR). THE FORWARD PRESSURE OF THE REAMER AND BALL TIPPED GUIDEWIRE CAUSING THE DEVICE TO COMPRESS AND BEND ALSO LIKELY CONTRIBUTED TO THE BREAK. RISK REVIEW PERFORMED USING FMEA-1002/1003 & PMS ANALYSIS (SECTION C.2) DFMEA-1003 REV P WAS REVIEWED FOR THE FAILURE MODE OF BURR/REAMER BREAKS DUE TO CUTTING HEAD BECOMING CAUGHT IN INSTRUMENT/BONE CEMENT (USER ERROR) AND DFMEA-1003 FOR 340 WAS IDENTIFIED WITH THE FAILURE MODE OF BURR / REAMER BREAKS DURING USE IN SURGICAL PROCEDURE AND A CAUSE OF USER HAS MISHANDLED THE INSTRUMENT WITH A SEVERITY AND OCCURRENCE OF 3, THE SEVERITY EXPERIENCED IN THE COMPLAINT MATCHES THE FMEA. THE POTENTIAL PATIENT EFFECT IS REPLACEMENT OF BURR / REAMER, POSSIBLY DELAY TO SURGICAL PROCEDURE. REMOVAL OF ALL PIECES IS SUPPORTED BY USE OF THESE DEVICES WITH BALL TIPPED GUIDEWIRE WHICH MATCHES THAT EXPERIENCED IN THE COMPLAINT. THE PATIENT EFFECT IN THIS COMPLAINT MATCHES THAT EXPERIENCED IN THE COMPLAINT AS ALL PIECES WERE ABLE TO BE REMOVED FROM THE PATIENT AS THEY STAYED ON THE GUIDEWIRE.