PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS CURRENTLY ONGOING, AND CONCLUSIONS ARE NOT YET AVAILABLE. A FOLLOW UP MDR WILL BE SUBMITTED UPON CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

TWO 9 X 120 MM BALLOONS WERE INSERTED PRIOR TO A TOTAL HIP ARTHROPLASTY. DURING THE CATHETER SEPARATION STEP THE SURGEON REALIZED ONE OF THE BALLOONS WAS NOT FULLY CURED WHEN THEY USED THE SCORING TUBE TO START THE SEPARATION PROCESS AND ONE OF THE BALLOONS WAS NOT SOLID. THE SURGEON THEN PULLED BOTH THE BALLOONS OUT BY HAND. ONE BALLOON WAS NOT CURED, AND ONE BALLOON WAS CURED. IT IS NOT BELIEVED THAT THERE WAS ANY MONOMER LEAK, AND NO LIQUID MONOMER WAS LEFT BEHIND. THE LED LIGHTBOX IN THIS CASE HAS BEEN SUCCESSFULLY USED IN OTHER CASES AFTER THIS COMPLAINT OCCURRED.

Additional Manufacturer Narrative

ROOT CAUSE ANALYSIS: THE TWO LED LIGHTBOXES RETURNED TO SUPPORT THIS COMPLAINT INVESTIGATION WERE EVALUATED AT ILLUMINOSS BY QUALITY ON 28 AUGUST 2025 FOLLOWING QIP FOR INSPECTIVE. BOTH LED LIGHTBOXES HAD ACCEPTABLE RESULTS FOR SPECS AND HAD IN SPECIFICATION LIGHT OUTPUTS. AS BOTH LIGHTBOXES FUNCTION PROPERLY AND HAVE IN SPECIFICATION LIGHT OUTPUT, THE LIGHTBOXES WERE ELIMINATED AS A POTENTIAL CAUSE OF THIS COMPLAINT. THE IMPLANT WHICH DID NOT CURE IN THIS CASE AND THE TWO LIGHT FIBERS USED IN THIS CASE WERE PHOTO DOCUMENTED AND THEN DECONTAMINATED AND RETURNED TO ILLUMINOSS. THE BALLOON CATHETER RETURNED TO ILLUMINOSS WAS CONFIRMED TO BE UNCURED AND THE CATHETER PORTION HAD 4 SIGNIFICANT BENDS/KINKS SUGGESTING THE IMPLANT CATHETER WAS SUBSTANTIALLY BENT DURING USE. THE IMPLANTS WERE USED IN THE PELVIS PRIOR TO A TOTAL HIP ARTHROPLASTY AND AFTER THE UNDER CURED IMPLANT WAS REMOVED A SCREW WAS USED IN THE RAMUS OF THE PELVIS, THEREFORE IT IS LIKELY THAT THE UNDER CURED IMPLANT WAS IMPLANTED IN THE RAMUS BEFORE IT WAS REMOVED DUE TO UNDER CURING. THE IMPLANTATION INTO THE RAMUS IN THE PELVIS MAY REQUIRE A SLIGHT BEND IN THE ILLUMINOSS IMPLANT TO BE IMPLANTED (SEE THE PELVIS STG 900589_A PAGE 9, FIGURE 17 FOR PLACEMENT OF BALLOON IMPLANT INTO THE SHEATH). IT IS POSSIBLE THAT THE PATIENT ANATOMY OR SURGICAL APPROACH USED REQUIRED A SIGNIFICANT BEND TO IMPLANT THE BALLOON IN THE RAMUS OF THE PELVIS WHICH RESULTED IN THE BENT AND KINKED CATHETER, OR THAT THE USER MISHANDLED THE BALLOON CATHETER AND INADVERTENTLY CREATED THE SIGNIFICANT KINKS IN THE BALLOON CATHETER (AND THUS THE LIGHT FIBER WHICH IS CONTAINED INSIDE THE BALLOON CATHETER). THE BENDS AND KINKS IN THE CATHETER ARE ALSO PRESENT IN ONE OF THE LIGHT FIBER ASSEMBLIES WHICH REDUCED THE LIGHT TRANSMISSION DOWN THE LIGHT FIBER. THE LIGHT FIBER ASSEMBLY USED TO ATTEMPT TO CURE THE UNDERCURED IMPLANT WAS ABLE TO BE IDENTIFIED FROM THE TWO RETURNED TO ILLUMINOSS BY MATCHING THE 4 SIGNIFICANT KINKS ALONG THE LENGTH OF THE FIBER TO THE CATHETER. THE RETURNED PRODUCT EVALUATION OF THIS LIGHT FIBER, WHEN CONNECTED TO A LIGHTBOX TO ILLUMINATE THE FIBER, SHOWED A SIGNIFICANT AMOUNT OF LIGHT WAS BEING RELEASED FROM THESE KINKS ALONG THE FIBER, AS THE LIGHT OUTPUT APPEARED BRIGHTER FROM THE KINKS ALONG THE FIBER THAN THE SPIRAL CUT PORTION WHERE THE MAJORITY OF THE LIGHT SHOULD BE OUTPUT. TO CONFIRM THE KINKS IN THE LIGHT FIBER CAUSED THE UNDER CURED IMPLANT, THE KINKED LIGHT FIBER WAS ATTEMPTED TO BE USED TO CURE A 9X120MM BALLOON CATHETER WITH THE LED LIGHTBOX, AND AFTER THE 500 SECOND CURE TIME, THE BALLOON WAS FOUND TO BE 75% UNCURED. THIS BENCH TOP TEST CONFIRMS THAT THE KINKS AND BENDS PRESENT AT THE DISTAL PORTION OF THE LIGHT FIBER CAUSED THE IMPLANT TO BE UNDER CURED AS WAS REPORTED IN THIS COMPLAINT. DHR REVIEW: TWO IMPLANTS WERE OPENED AT THE SAME TIME DURING SURGERY, AND ONE CURED AND ONE DID NOT. THE REP IS NOT SURE WHICH LOT NUMBER CORRESPONDED WITH THE IMPLANT THAT DID NOT CURE, SO THE DHRS OF BOTH IMPLANTS USED WERE REVIEWED. THE DHR REVIEW OF THE IMPLANTS FOCUSED ON THE LIGHT FIBER ASSEMBLY AND MONOMER COMPONENTS OF THE IMPLANT KIT BECAUSE THESE ARE THE PARTS THAT ARE RELATED TO THE CURING OF THE BALLOON. BOTH LOTS OF IMPLANTS WERE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE DHRS OF THE LIGHT FIBER ASSEMBLIES AND MONOMER MET ALL SPECIFICATIONS, INCLUDING THOSE RELATED TO LIGHT OUTPUT AND CURING PARAMETERS. THERE IS NO INDICATION THAT MANUFACTURING CONTRIBUTED TO THIS COMPLAINT. AS BOTH LED LIGHTBOXES WHICH MAY HAVE BEEN USED IN THIS CASE WERE RETURNED AND EVALUATED AND WERE FOUND IN SPECIFICATION AND ELIMINATED AS A CAUSE OF THIS COMPLAINT, NO DHR REVIEW FOR THE LIGHTBOXES IS REQUIRED FOR THIS COMPLAINT INVESTIGATION. IFU REVIEW AND POTENTIAL FOR USER ERROR: THE IMPLANTS IN THIS CASE WERE USED IN THE PELVIS IN THE US, WHICH IS ON LABEL USE. THE RETURNED PRODUCT EVALUATION SUGGESTS THAT INADVERTENT MISUSE CAUSED THE IMPLANT TO BE UNDER CURED DUE TO THE PRESENCE OF SEVERAL SIGNIFICANT KINKS ALONG THE BALLOON CATHETER AND LIGHT FIBER ASSEMBLY. THE STG FOR PELVIS 900598_A STATES "DO NOT FORCE OR SIGNIFICANTLY BEND THE BALLOON CATHETER ASSEMBLY OR LIGHT FIBER DURING ITS DELIVERY INTO THE SHEATH AS DAMAGE TO THE IMPLANT MIGHT OCCUR[?]DO NOT SEVERELY BEND OR KINK THE LIGHT FIBER, CATHETER OR BALLOON IMPLANT, HANDLE COMPONENTS WITH CARE, SEVERE BENDS OR KINKS IN THE IMPLANT ASSEMBLY WILL SUBSTANTIALLY REDUCE THE LIGHT INTENSITY DELIVERED TO THE IMPLANT CAUSING INCOMPLETE HARDENING OF THE LIQUID MONOMER[?]DAMAGE TO THE LIGHT FIBER MAY RESULT IN FIBER BREAKAGE OR SIGNIFICANT REDUCTION IN THE LIGHT INTENSITY TO THE IMPLANT RESULTING IN INCOMPLETE HARDENING OF THE LIQUID MONOMER." THE IFU 900971_B ALSO STATES RISKS INCLUDE A MALFUNCTION OF THE PHOTODYNAMIC PROCESS. THEREFORE, THE STG INCLUDES INSTRUCTIONS NOT TO SEVERELY BEND THE BALLOON CATHETER ASSEMBLY AS IT MAY CAUSE INCOMPLETE HARDENING OF THE LIQUID MONOMER AND THE IFU INCLUDES THE RISK EXPERIENCED OF A MALFUNCTION OF THE PHOTODYNAMIC PROCESS. BASED ON THE 4 SIGNIFICANT BENDS ALONG THE BALLOON CATHETER AND LIGHT FIBER, THE CAUSE OF THIS COMPLAINT IS THE USER INADVERTENTLY CAUSING SIGNIFICANT BENDS IN THE BALLOON CATHETER DURING THE PROCEDURE, WHICH BENT AND KINKED THE LIGHT FIBER, CAUSING REDUCED LIGHT OUTPUT AT THE DISTAL END AND UNDER CURING. CONCLUSION: THE CAUSE OF THE UNDER CURED IMPLANT IS DUE TO THE USER SEVERELY BENDING AND KINKING THE BALLOON CATHETER AND LIGHT FIBER, EITHER DUE TO THE ANATOMY OF THE RAMUS IN WHICH THE USER WAS UNABLE TO ACHIEVE A LOW ANGLE OF ENTRY CAUSING THE ASSEMBLY TO BE BENT AS IT WAS INSERTED INTO THE PELVIS, OR DUE TO THE USER INADVERTENTLY BENDING THE CATHETER DURING INSERTION AND POSITIONING PRIOR TO CURING.

Description of Event or Problem

TWO 9X120MM BALLOONS WERE INSERTED PRIOR TO A TOTAL HIP ARTHROPLASTY. DURING THE CATHETER SEPARATION STEP THE SURGEON REALIZED ONE OF THE BALLOONS WAS NOT FULLY CURED WHEN THEY USED THE SCORING TUBE TO START THE SEPARATION PROCESS AND ONE OF THE BALLOONS WAS NOT SOLID. THE SURGEON THEN PULLED BOTH THE BALLOONS OUT BY HAND. ONE BALLOON WAS NOT CURED, AND ONE BALLOON WAS CURED. IT IS NOT BELIEVED THAT THERE WAS ANY MONOMER LEAK, AND NO LIQUID MONOMER WAS LEFT BEHIND. THE LED LIGHTBOX IN THIS CASE HAS BEEN SUCCESSFULLY USED IN OTHER CASES AFTER THIS COMPLAINT OCCURRED.