PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

DURING AN SI JOINT STABILIZATION PROCEDURE IN THE PELVIS, THEY WERE USING A 6.0MM REAMER AS THE FIRST REAMER WITH THE BALL POINT WIRE WHICH GOT APPROXIMATELY HALFWAY THROUGH THE PELVIS, THEY POSSIBLY HIT SCLEROTIC BONE, THERE WAS A SMALL SLIGHT CURVE, AND THE REAMER SNAPPED ABOUT AN INCH FROM THE DISTAL HEAD. THEY WERE ABLE TO GET ALL THE PIECES OF THE REAMER OUT OF THE PATIENT. THERE WAS NO SIGNIFICANT IMPACT ON THE PATIENT WITH A 15 MINUTES OF DELAY.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION DHR REVIEW: THE DHR OF THE REAMER LOT WAS REAMER LOT WAS REVIEWED AND THE PARTS MET ALL SPECIFICATIONS AT THE TIME OF MANUFACTURE AND RELEASE. RETURNED PRODUCT EVALUATION: THE BROKEN REAMER WAS DECONTAMINATED AND CLEANED BY THE HOSPITAL AND THEN RETURNED TO ILLUMINOSS MEDICAL FOR EVALUATION. THE REAMER HAD A CLEAN BREAK HORIZONTAL BREAK BETWEEN TWO OF THE LASER CUT KERF LINES. THERE WAS NO VISIBLE UNRAVELING, TIGHTENING, OR WARPING OF THE KERFS, WHICH INDICATES THE REAMER BROKE WHILE TURNING AT HIGH SPEEDS AND THE BREAK WAS SUDDEN. TORSION TESTING ON FLEXIBLE SHAFTS IN ENS-TESTING WAS PERFORMED AT A SPEED OF 360 DEGREES/MINUTE (VERY SLOW COMPARED TO REAMING SPEEDS FOR CLINICAL USE) UNTIL FAILURE AND THE DISTORTION OF THE KERFS IS VISIBLE, WHILE THERE WAS NO VISIBLE DISTORTION OF THE KERFS IN THE REAMER FROM THIS COMPLAINT, SUGGESTING IT WAS A HIGH SPEED BREAK. THE INFORMATION RECEIVED ABOUT THIS COMPLAINT STATES THAT THE USER MAY HAVE HIT SCLEROTIC BONE, WHICH IS BONE THAT IS ABNORMALLY DENSE AND HARD AND CAN BE CAUSED BY METASTATIC DISEASE AMONG OTHER CAUSES. THE REP ALSO STATED THERE WAS A SLIGHT CURVE IN THE CANAL WHEN THE REAMER BROKE. IF THE REAMER WAS MOVING AT HIGH SPEED AND THE REAMER HEAD SUDDENLY HIT THE SCLEROTIC BONE, IT IS LIKELY THAT THE REAMER SHAFT WAS SUDDENLY OVER TORQUED AS THE DISTAL REAMER HEAD SIGNIFICANTLY SLOWED DOWN WHEN IT HIT THE HARD BONE, AND THE PROXIMAL END REMAINED SPINNING FAST CONNECTED TO THE DRILL. THIS, IN ADDITION TO THE TURN IN THE CANAL ADDING A BEND TO THE REAMER SHAFT, MOST LIKELY CAUSED THE REAMER SHAFT TO SUDDENLY BREAK. IFU REVIEW AND POTENTIAL FOR USER ERROR: THE STG FOR PELVIS 900598_A STATES, "NOTE: THE 4.5MM BURR, WHICH IS PROVIDED AS A FRONT CUTTING IS THE FIRST SIZE BURR TO START THE CANAL PREPARATION TO ALLOW FOR THE DELIVERY OF THE SHEATH AND DILATOR." IN THIS COMPLAINT THE REP STATED THAT THEY WERE USING THE 6.0MM REAMER AS THE FIRST REAMER. THE STG INCLUDES INSTRUCTIONS TO START WITH THE 4.5MM FRONT CUTTING BURR, THEN EXCHANGE FOR THE NEXT SEQUENTIALLY LARGER SIZE. IN THIS CASE THE USER STARTED WITH THE 6.0 MM BURR, WHICH SUBSEQUENTLY BROKE WHEN IT HIT SCLEROTIC BONE AND WAS BEING MOVED THROUGH A BEND IN THE CANAL. THE USER ERROR OF USING THE 6.0MM BURR AS THE FIRST BURR INSTEAD OF THE SMALLER 4.5MM FRONT CUTTING BURR MOST LIKELY CAUSED THIS COMPLAINT AS THE USE OF THE SMALLER FRONT CUTTING BURR WOULD HAVE CLEARED A SMALLER DIAMETER IN THE BONE SUCH THAT THE 6.0MM BURR HAD LESS MATERIAL TO REMOVE, AND WOULD BE LESS LIKELY TO SLOW DOWN SO SIGNIFICANTLY WHEN IT HIT THE SCLEROTIC BONE AND BE SUDDENLY OVER TORQUED. CONCLUSION: THE CAUSE OF THE BROKEN REAMER WAS DUE TO IMPROPER TECHNIQUE WHEN USING THE BURRS (STARTING WITH THE 6.0MM BURR INSTEAD OF THE 4.5MM FRONT CUTTING BURR PER THE STG). THERE WERE ALSO MULTIPLE CONTRIBUTING FACTORS RELATED TO THE PATIENT ANATOMY: AN AREA OF SCLEROTIC BONE WHICH IS ABNORMALLY DENSE AND HARD, AND A SLIGHT BEND IN THE CANAL. THE COMBINATION OF THESE FACTORS LIKELY RESULTED IN THE HEAD OF THE REAMER SUBSTANTIALLY SLOWING DOWN WHEN IT HIT THE SCLEROTIC BONE, THE SHAFT EXPERIENCING A BEND DUE TO THE ANATOMY, WHILE THE PROXIMAL END OF THE REAMER REMAINED SPINNING FAST BY THE USER, CAUSING A SUDDEN OVER TORQUING OF THE SHAFT, BREAKING THE REAMER BETWEEN TWO KERFS.