PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

A USSL-2213240 ILLUMINOSS IMPLANT WAS NOT FULLY CURED DURING A CASE.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION. RETURNED PRODUCT EVALUATION: THE UNDER CURED IMPLANT AND THE LIGHTBOX USED IN THE CASE WERE RETURNED TO ILLUMINOSS FOR EVALUATION. AN MHB LIGHTBOX (PAIRED WITH LIGHT GUIDE) WAS EVALUATED BY QUALITY. THE LIGHTBOX WAS FOUND TO FUNCTION AS EXPECTED AND HAD PASSING LIGHT BOX OUTPUT AND PASSING LIGHT GUIDE OUTPUT. THE LIGHT GUIDE WAS VISUALLY INSPECTED AND THERE WAS NO VISUAL DAMAGE OR KINKS TO THE LENGTH OF THE LIGHT FIBER AND THE PROXIMAL END OF THE LIGHT FIBER WAS FREE FROM DEBRIS. THERE WAS SOME DEBRIS INSIDE THE RING OF THE GOLD OPTICAL TAPER AND A SMALL AMOUNT OF DISCOLORATION ON PART OF THE OPTICAL TAPER (HOWEVER NOT ENOUGH TO REDUCE THE LIGHT OUTPUT BELOW SPECIFICATION). THE DISCOLORATION ON THE OPTICAL TAPER WAS PRESENT IN A RING ALONG THE CIRCUMFERENCE OF THE OPTICAL TAPER. THE PASSING LIGHT OUTPUT FROM THE LIGHTBOX AND LIGHT GUIDE PAIR INDICATES THAT THE CAUSE OF THE UNDER CURED IMPLANT IS NOT DUE TO INSUFFICIENT LIGHT OUTPUT FROM THE LIGHT SYSTEM, BUT INSUFFICIENT LIGHT TRANSMISSION FROM THE LIGHT SYSTEM DOWN THE LIGHT FIBER. THE UNDER CURED IMPLANT WAS SENT OUT FOR PHOTODOCUMENTATION THEN DECONTAMINATION. THE PHOTODOCUMENTATION SHOWED THE IMPLANT WAS SUBSTANTIALLY UNDER CURED AS ONLY A THIN CORE OF CURED MONOMER WAS FOUND ON THE CENTRAL LUMEN OF THE BALLOON CATHETER. THE SPIRAL SHAPE OF THE MONOMER IS A RESULT OF THE CUT SPIRAL SHAPE ON THE LIGHT FIBER. WHEN AN IMPLANT IS UNDER CURED, AND THE UNCURED LIQUID MONOMER IS WASHED AWAY, A SPIRAL OF CURED MONOMER REMAINS AS THE LIGHT OUTPUT FROM THE FIBER IS STRONGEST ALONG THE CUT SPIRAL OF THE FIBER, AND THEREFORE THE MONOMER IN THIS AREA CURES FIRST. AT THE PROXIMAL END OF THE LIGHT FIBER INSIDE THE HUB, THE LIGHT FIBER APPEARS TO BE MELTED AND BURNED. THERE IS A SMALL CLEAR DISK AROUND THE EDGE OF THE LIGHT FIBER AND A DARK BROWNISH RED PORTION AT THE CENTER, NEITHER OF WHICH WOULD BE EXPECTED TO BE PRESENT AFTER THE LIGHT FIBER WAS USED IN A CASE. THE SMALL CLEAR DISK AROUND THE EDGE OF THE LIGHT FIBER IS MOST LIKELY WHERE THE LIGHT FIBER MELTED AND THE DARK BROWNISH RED PORTION IS MOST LIKELY WHERE THE LIGHT FIBER WAS BURNED. THE MELTED AND BURNED CENTER OF THE LIGHT FIBER WOULD SUBSTANTIALLY REDUCE THE LIGHT TRANSMISSION FROM THE OPTICAL TAPER OF THE LIGHT GUIDE TO THE LIGHT FIBER AND THUS REDUCE THE LIGHT TRANSMISSION TO THE IMPLANT CAUSING UNDER CURING. DHR REVIEW: THE DHR OF THE IMPLANT AND LIGHTBOX WERE REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE LIGHTBOX WAS ORIGINALLY RELEASED WITH LIGHT GUIDE AND WAS RETURNED WITH LIGHT GUIDE; HOWEVER, THE RETURNED PRODUCT EVALUATION FOUND THE LIGHT GUIDE LIGHT OUTPUT IN SPECIFICATION SO THIS DID NOT CAUSE THE IMPLANT TO BE UNDER CURED. IT WAS DETERMINED THAT SINCE THE LIGHT BOX'S RELEASE IN 2020 IT HAS NEVER RETURNED TO ILLUMINOSS FOR SERVICE, AND IT HAS BEEN MOVED TO 6 DIFFERENT LOCATIONS FOR USE. THE LIGHT GUIDE WAS MOST LIKELY INADVERTENTLY SWAPPED WITH ANOTHER LIGHT GUIDE WHILE IN THE FIELD, ESPECIALLY GIVEN THE LIGHT SYSTEM HAS BEEN AT 6 DIFFERENT LOCATIONS SINCE ITS RELEASE, WHICH EXPLAINS WHY THE LIGHTBOX WAS RETURNED WITH A DIFFERENT LIGHT GUIDE THAN IT WAS ORIGINALLY RELEASED WITH. THE MANUFACTURING RECORDS OF THE LIGHT FIBER USED IN THIS DEVICE WERE REVIEWED AND ALL LIGHT FIBERS WHICH WERE RELEASED PASSED THEIR LIGHT OUTPUT INSPECTION. IF THE LIGHT FIBER HAD THE MELTED/BURNED FIBER PROXIMAL END PRESENT WHICH CAUSED REDUCED LIGHT OUTPUT, IT WOULD HAVE BEEN IDENTIFIED DURING THIS 100% LIGHT OUTPUT INSPECTION STEP. THEREFORE, THE LIGHT FIBER MELTING/BURNING ON THE DISTAL END OCCURRED DURING THE CURING OF THE IMPLANT DURING THE CASE. THE DHR OF THE SPIRAL CUT LIGHT FIBER THE LOT WAS REVIEWED AND ALL THE LIGHT FIBERS IN THIS LOT HAD ALL MANUFACTURING STEPS PERFORMING INCLUDING TERMINATING/POLISHING THE PROXIMAL END AND REMOVING CLADDING FLASH FROM BOTH ENDS. IFU REVIEW AND POTENTIAL FOR USER ERROR IFU 900356_X STATES, "RISKS SPECIFIC TO A PHOTODYNAMIC CURING SYSTEM CAN INCLUDE: · MALFUNCTION OF PHOTODYNAMIC PROCESS" SO THE RISK EXPERIENCED IN THIS COMPLAINT IS CAPTURED IN THE LABELING. THERE IS NO INDICATION THAT USER ERROR OR OFF LABEL USE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE IFUS FOR THE MHB LIGHTBOX 900368_G AND 900093_X STATE TO VISUALLY INSPECT BOTH ENDS OF THE LIGHT GUIDE TO VERIFY NO FOREIGN MATERIAL IS PRESENT. THE LIGHT GUIDE ENDS MAY BE CLEANED WITH 70% IPA AS REQUIRED. THEREFORE, THERE ARE APPROPRIATE INSTRUCTIONS IN THE IFU TO VISUALLY INSPECT THE ENDS OF THE LIGHT GUIDE TO VERIFY NO FOREIGN MATERIAL IS PRESENT. POTENTIAL ROOT CAUSES: BASED ON THE INFORMATION ABOVE THE POTENTIAL ROOT CAUSES ARE: -LIGHT FIBER POSITIONED INCORRECTLY IN THE HUB. -UNPOLISHED PROXIMAL FIBER END (ALLOWING LIGHT FIBER HAIRS TO REMAIN). -ENVIRONMENTAL CONTAMINATION ON OPTICAL TAPER FACE. PREVIOUS COMPLAINTS WITH THE SAME FAILURE MODE AND CAUSE (UNDER CURED IMPLANT DUE TO MELTED/BURNED PROXIMAL LIGHT FIBER END) WERE INVESTIGATED IN DEPTH IN CAPA. BENCHTOP TESTING WAS PERFORMED TO INVESTIGATE THESE THREE POTENTIAL ROOT CAUSES BY ATTEMPTING TO RECREATE THE FAILURE MODE OF A MELTED/BURNED LIGHT FIBER. ONLY THE CAUSE OF ENVIRONMENTAL DEBRIS ON THE OPTICAL TAPER FACE WAS ABLE TO CAUSE THE OBSERVED MELTING/BURNING OF THE LIGHT FIBER. THE CAPA ALSO DETERMINED IT IS MORE LIKELY THAT ENVIRONMENTAL CONTAMINATION WAS INTRODUCED TO THE LIGHT GUIDE (RATHER THAN THE LIGHT FIBER) AS THE LIGHT GUIDE IS NOT MAINTAINED IN A CLEANROOM ENVIRONMENT LIKE THE LIGHT FIBER IS AND IS NOT PACKAGED IN STERILE PACKAGING BEFORE USE WHICH WOULD PREVENT CONTAMINATION. THE DISTAL END OF THE LIGHT FIBER IS NOT CAPPED OR COVERED BETWEEN USERS AND IS A REUSABLE DEVICE, MAKING IT MORE LIKELY THE CONTAMINATION WAS INTRODUCED TO THE LIGHT GUIDE. THIS CAPA ADDED A UFMEA LINE ITEM TO CAPTURE THIS FAILURE MODE AND CAUSE IN THE RISK DOCUMENTATION. AS THE RETURNED PRODUCT EVALUATION FOR THIS COMPLAINT IS IDENTICAL TO THOSE INVESTIGATED IN CAPA, AND THERE IS NO INDICATION THAT A MANUFACTURING NONCONFORMITY CAUSED THE LIGHT FIBER TO BE POSITIONED INCORRECTLY IN THE HUB OR THERE TO BE AN UNPOLISHED PROXIMAL FIBER END, THE CAUSE OF THIS COMPLAINT IS DUE TO ENVIRONMENTAL CONTAMINATION ON THE OPTICAL TAPER FACE OF THE LIGHT FIBER. THIS IS FURTHER SUPPORTED BY THE VISIBLE DEBRIS IN THE GOLD HOUSING OF THE OPTICAL TAPER WHICH SHOWS THAT SOME ENVIRONMENTAL CONTAMINATION WAS INTRODUCED TO THE DISTAL END OF THE LIGHT FIBER, MAKING IT LIKELY SOME WAS PRESENT ON THE OPTICAL TAPER AS WELL. IT IS LIKELY THAT THE ENVIRONMENTAL CONTAMINATION ON THE LIGHT GUIDE FUSED WITH THE END OF THE LIGHT FIBER WHEN IT WAS MELTING AND WAS THEN PULLED OFF THE LIGHT GUIDE WHEN THE LIGHT FIBER WAS DISCONNECTED FROM THE LIGHT GUIDE AFTER THE CURING WAS COMPLETE. THE REP STATED THAT ANOTHER IMPLANT WAS USED WITH THE SAME LIGHT BOX AFTER THE FIRST IMPLANT WAS FOUND TO BE UNDER CURED AND THAT IMPLANT CURED PROPERLY. THE RETURNED PRODUCT EVALUATION ALSO FOUND IN SPECIFICATION LIGHT OUTPUT AND ONLY A SMALL AMOUNT OF DEBRIS PRESENT ALONG THE VERY OUTER RING OF THE OPTICAL TAPER FACE, WHILE THE CENTER WAS CLEAR OF VISIBLE DEBRIS. THIS ALL SUPPORTS THE CONCLUSION THAT THE DEBRIS ON THE OPTICAL TAPER FACE WHICH CAUSES THE MELTING/BURNING ADHERED TO THE LIGHT FIBER AND WAS REMOVED WHEN THE FIBER WAS. CONCLUSION: THE CAUSE OF THE UNDER CURED IMPLANT WAS DUE TO FOREIGN MATERIAL ON THE OPTICAL TAPER OF THE LIGHT GUIDE WHEN THE LIGHT FIBER WAS INSERTED CAUSING THE OBSTRUCTION OF LIGHT TRANSMISSION. WHEN FOREIGN MATERIAL IS PRESENT ON THE OPTICAL TAPER REDUCING THE TRANSMISSION OF LIGHT DOWN THE LIGHT FIBER, HEAT CAN BE GENERATED, WHICH CAN BURN THE FOREIGN MATERIAL AND/OR BURN AND MELT THE LIGHT FIBER.

Description of Event or Problem

A USSL-2213240 ILLUMINOSS IMPLANT WAS NOT FULLY CURED DURING A CASE.

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.