PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION: A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD ON 18 JULY 2024 WHERE THE INFORMATION AND X-RAYS IN THIS CASE WERE REVIEWED. THE MEDICAL REVIEWER STATED THAT THERE WAS NOT AN EXTREME BEND IN THE REAMER BASED ON THE PATIENT ANATOMY. MEDICAL REVIEWER ALSO NOTED THAT BASED ON THE X-RAYS AND INFORMATION PROVIDED THERE IS NO EVIDENT REASON FOR THE REAMER TO HAVE BECOME INCARCERATED, AND THE REP PRESENT IN THE CASE STATED THE REAMER WAS NOT INCARCERATED IN BONE WHEN IT BROKE. VP OF ENGINEERING WAS CONSULTED WITH THE COMPLAINT INFORMATION AND OBSERVED THAT THE BALL TIP POPPING OFF THE SHAFT WITHOUT SEEMINGLY ANY FORCE COULD INDICATE THAT IT WAS NOT PROPERLY WELDED DURING MANUFACTURE, BUT WITHOUT BEING ABLE TO ANALYZE THE PRODUCT IN THIS CASE, THE DEFINITIVE CAUSE CANNOT BE KNOWN, BUT IT IS LIKELY DUE THE MANUFACTURING PROCESS RESULTING IN AN INSUFFICIENT WELD BETWEEN THE SHAFT AND BALL TIP. THE 2.0MM BALL TIP GUIDEWIRE (SUB ASSEMBLY PN 300782) IS MANUFACTURED BY A TWO PIECE CONSTRUCTION IN WHICH THE BALL TIP IS WELDED TO THE SHAFT. THE VP OF ENGINEERING WAS ALSO CONSULTED ABOUT THE CAUSE OF THE REAMER BREAK AND NOTED THAT THE TIBIA CANAL LOOKS LARGE ENOUGH TO ACCOMMODATE THE 8MM REAMER, AND WHILE THERE WAS A BEND IN THE SHAFT AT THE RETROGRADE ENTRY POINT OF THE TIBIA, THAT IS UNLIKELY THE CAUSE OF THE REAMER BREAKING MUCH HIGHER DISTALLY DOWN THE SHAFT. THE X-RAYS PROVIDED DO NOT SHOW THE ENTIRE VIEW OF THE REAMER IN THE BONE CANAL, AND DO NOT SHOW THE DISTAL END OF THE REAMER. IT IS POSSIBLE THAT THE REAMER HEAD BECAME ENGAGED IN SOME OTHER INSTRUMENT OR DEVICE SUCH AS A TOTAL KNEE IMPLANT OR OTHER HARDWARE. DHR REVIEW: THE DHR OF THE BALL TIPPED GUIDEWIRE LOT 440684 WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE LOT NUMBER OF THE BROKEN REAMER IS UNKNOWN SO THE DHR OF THIS DEVICE COULD NOT BE REVIEWED. RETURNED PRODUCT EVALUATION: NO RETURNED PRODUCT EVALUATION IS POSSIBLE AS BOTH DEVICES WERE DISCARDED IN THE OR. IFU REVIEW THE IFU 900356_X STATES THAT RISKS INCLUDE INABILITY TO PROPERLY DEPLOY OR REMOVE THE DEVICE, SO IF THE BALL TIPPED GUIDEWIRE WAS NOT ABLE TO BE REMOVED BY USING AN INSERTION SHEATH, THEN THIS RISK IS CAPTURED IN THE RISK DOCUMENTATION. CONCLUSION: THE ROOT CAUSE OF THE BALL TIPPED GUIDEWIRE POPPING OFF THE SHAFT IS UNKNOWN WITH THE AVAILABLE INFORMATION, BUT IT IS LIKELY DUE TO THE MANUFACTURING PROCESS IN WHICH THE BALL TIP IS WELDED ONTO THE SHAFT BEING INCORRECTLY OR INSUFFICIENTLY PERFORMED FOR THIS DEVICE. THE ROOT CAUSE OF THE REAMER BREAKING IS UNKNOWN WITH THE AVAILABLE INFORMATION BUT BASED ON A REVIEW OF THE FAILURE MODES AND CAUSES IN DFMEA-1003, THE MOST LIKELY CAUSE IS DUE TO THE FLEXIBLE SHAFT HAVING AN INADEQUATE TORQUE RATING.

Description of Event or Problem

A 60 YEAR OLD FEMALE WAS BEING TREATED FOR A TRAUMATIC TIBIA FRACTURE. THE SURGEON WAS ADVANCING A 2.0MM BALL TIPPED GUIDEWIRE AND THEN PULLED THE GUIDEWIRE DOWN TO MOVE IT TO TAKE A MEASUREMENT AND THE BALL TIP POPPED OFF THE SHAFT. THE SHAFT OF THE GUIDEWIRE WAS REMOVED, AND A NEW 2.0MM BALL TIP GUIDEWIRE INSERTED TO REAM THE CANAL. THE REAMER BROKE DURING USE ABOUT ONE THIRD OF THE WAY DOWN THE LENGTH FROM THE DISTAL END. THE REAMER WAS NOT INCARCERATED IN BONE WHEN IT BROKE, THEY WERE ADVANCING IT IN THE FORWARD DIRECTION, AND IT BROKE. ALL PIECES OF THE REAMER WERE ABLE TO BE REMOVED WITH THE USE OF THE SECOND GUIDEWIRE. ANOTHER USER SCRUBBED INTO THE CASE AND WAS ABLE TO CAPTURE THE GUIDEWIRE TIP USING AN INSERTION SHEATH AND REMOVE IT FROM THE PATIENT. NO DEVICE FRAGMENTS FROM THE BROKEN GUIDEWIRE OR BROKEN REAMER WERE LEFT RETAINED IN THE PATIENT. THIS CAUSED A SURGICAL DELAY OF ABOUT 20-25 MINUTES.

Additional Manufacturer Narrative

THE INVESTIGATION IS PENDING FURTHER INFORMATION.

Description of Event or Problem

A 60 YEAR OLD FEMALE WAS BEING TREATED FOR A TRAUMATIC TIBIA FRACTURE. THE SURGEON WAS ADVANCING A 2.0MM BALL TIPPED GUIDEWIRE AND THEN PULLED THE GUIDEWIRE DOWN TO MOVE IT TO TAKE A MEASUREMENT AND THE BALL TIP POPPED OFF THE SHAFT. THE SHAFT OF THE GUIDEWIRE WAS REMOVED, AND A NEW 2.0MM BALL TIP GUIDEWIRE INSERTED TO REAM THE CANAL. THE REAMER BROKE DURING USE ABOUT ONE THIRD OF THE WAY DOWN THE LENGTH FROM THE DISTAL END. THE REAMER WAS NOT INCARCERATED IN BONE WHEN IT BROKE, THEY WERE ADVANCING IT IN THE FORWARD DIRECTION, AND IT BROKE. ALL PIECES OF THE REAMER WERE ABLE TO BE REMOVED WITH THE USE OF THE SECOND GUIDEWIRE. ANOTHER USER SCRUBBED INTO THE CASE AND WAS ABLE TO CAPTURE THE GUIDEWIRE TIP USING AN INSERTION SHEATH AND REMOVE IT FROM THE PATIENT. NO DEVICE FRAGMENTS FROM THE BROKEN GUIDEWIRE OR BROKEN REAMER WERE LEFT RETAINED IN THE PATIENT. THIS CAUSED A SURGICAL DELAY OF ABOUT 20-25 MINUTES.