PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THIS INVESTIGATION INTO THIS EVENT IS CURRENTLY ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

AN EVENT WAS REPORTED IN WHICH THE IMPLANT DID NOT FULLY CURE. THE PROXIMAL PORTION OF THE BALLOON CURED, WHILE THE DISTAL PORTION REMAINED UNCURED. THE PHYSICIAN PLACED A SECOND BALLOON RETROGRADE TO COMPLETE FILLING OF THE LESION.

Description of Event or Problem

AN EVENT WAS REPORTED IN WHICH THE IMPLANT DID NOT FULLY CURE. THE PROXIMAL PORTION OF THE BALLOON CURED, WHILE THE DISTAL PORTION REMAINED UNCURED. THE PHYSICIAN PLACED A SECOND BALLOON RETROGRADE TO COMPLETE FILLING OF THE LESION.

Additional Manufacturer Narrative

EVENT DESCRIPTION: A 17X280MM IMPLANT DID NOT COMPLETELY CURE. THE PROXIMAL PORTION OF THE BALLOON CURED, THE DISTAL PORTION DID NOT. THE USER PLACED A SECOND BALLOON RETROGRADE TO FILL THE LESION. FOLLOW UP INFORMATION: THE SALES REP INVOLVED IN THIS COMPLAINT STATED THAT DURING THE CASE THE LIGHT FIBER HAD NO VISIBLE DAMAGE TO IT. ANY DAMAGE OBSERVED UPON RETURN TO ILLUMINOSS WAS DUE TO HANDLING AFTER THE CASE TO PACK IT UP AND RETURN IT. THE SIGNIFICANT BEND AND BREAK IN THE LIGHT FIBER OBSERVED IN THE PRODUCT RETURN WERE NOT PRESET DURING THE CURING PROCESS OF THE CASE. THE SECOND BALLOON UTILIZED WAS CURED WITH THE SAME LIGHTBOX AND THIS IMPLANT HAD NO ISSUES CURING. THE USER DID NOT REMOVE THE PARTIALLY CURED MONOMER/IMPLANT FROM THE PATIENT. THE TOP HALF OF THE BALLOON CURED, AND WHEN THEY REALIZED THE BOTTOM HALF OF THE IMPLANT HAD NOT CURE FULLY, IT COULD NOT BE REMOVED AS IT WAS HALF CURED, SO THERE WAS NO LIQUID TO REMOVE. THE PATIENT OUTCOME WAS GOOD AND THE DOCTOR WAS VERY HAPPY WITH THE OUTCOME. ROOT CAUSE INVESTIGATION DHR REVIEW: THE DHR OF THE IMPLANT USED IN THIS CASE WAS REVIEWED AND FOUND IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. ALL LIGHT FIBER ASSEMBLIES USED IN THIS LOT PASSED THEIR LIGHT FIBER OUTPUT INSPECTION TEST VERIFYING IN SPECIFICATION LIGHT OUTPUT. THE DHR OF THE MONOMER USED IN THIS CASE WAS REVIEWED AND ALL MATERIAL PROPERTIES WERE FOUND IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THERE IS NO INDICATION THAT ANY MANUFACTURING NONCONFORMITIES OCCURRED OR THAT THE MANUFACTURE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE COMPLAINT. THE DHR OF THE LIGHTBOX WAS REVIEWED AND FOUND IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THERE IS NO INDICATION THAT ANY MANUFACTURING NON CONFORMITIES OCCURRED OR THE MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE COMPLAINT. RETURNED PRODUCT EVALUATION: THE LIGHTBOX AND LIGHT GUIDE WERE RETURNED TO ILLUMINOSS. THE LIGHT BOX AND LIGHT GUIDE WAS EVALUATED AND THERE WAS NO OBVIOUS PHYSICAL DAMAGE TO THE UNIT AND ALL SPECIFICATIONS MEASURED, INCLUDING LIGHT OUTPUT, WERE MET. THEREFORE, THE LIGHTBOX CAN BE ELIMINATED AS THE CAUSE OF THIS CURING FAILURE. THIS IS CONSISTENT WITH THE COMPLAINT INFORMATION RECEIVED AS THE SECOND IMPLANT INSERTED AND CURED USING THE SAME LIGHTBOX CURED PROPERLY, INDICATION THAT THE CURING FAILURE WAS NOT DUE TO THE LIGHT BOX. A PORTION OF THE IMPLANT KIT WAS ALSO RETURNED WITH THE LIGHTBOX FOR EVALUATION. THE FINISHED GOOD BOX CONTAINED THE BACKER CARD (FOLDED), IFUS, TIMER CARD, AND A BROKEN PORTION OF THE LIGHT FIBER. THE LIGHT FIBER WAS BROKEN OFF BEFORE THE START OF THE SPIRAL MARKING AND THERE WERE TWO SIGNIFICANT BENDS (ABOUT 90 DEGREES) IN THE LIGHT FIBER. THE RETURNED PRODUCT EVALUATION SUGGESTS THAT DAMAGE TO THE LIGHT FIBER IS A POTENTIAL CAUSE OF THE COMPLAINT DUE TO THE SUBSTANTIAL KINKING AND BREAKS OBSERVED, WHICH WOULD SUBSTANTIALLY REDUCE THE AMOUNT OF LIGHT TRANSMITTED THROUGH THE LIGHT FIBER AND COULD CAUSE AN IMPLANT TO BE UNDER CURED. IFU REVIEW AND POTENTIAL FOR USER ERROR THE ILLUMINOSS WAS USED TO TREAT A FEMUR IN CONJUNCTION WITH A SUPPLEMENTAL PLATE AND SCREWS IN THE US WHICH IS ON LABEL. IFU 900356_X STATES THAT RISKS INCLUDE MALFUNCTION OF THE PHOTODYNAMIC PROCESS, AND THAT IF AN UNCURED OR PARTIALLY CURED IMPLANT IS SUSPECTED, ADDITIONAL CURING CYCLES SHOULD BE COMPLETED. IN THIS CASE, ADDITIONAL CURING CYCLES WERE NOT COMPLETED, MOST LIKELY BECAUSE THE UNDER CURED IMPLANT WAS NOT IDENTIFIED UNTIL AFTER THE LIGHT FIBER HAD BEEN REMOVED, AND INSTEAD ANOTHER BALLOON WAS INSERTED TO FILL THE LESION. THE STG FOR FEMUR & TIBIA 900611_C INCLUDES A SECTION ON HANDLING OF THE LIGHT FIBER AND TO NOT SEVERELY BEND OR KINK, PULL OR TUG, APPLY INSTRUMENTS OR CLAMPS AND AVOID CONTACT OF THE LIGHT FIBER WITH SHARP OBJECTS. IT STATES THAT DAMAGE TO THE LIGHT FIBER MAY RESULT IN FIBER BREAKAGE OR REDUCTION IN LIGHT INTENSITY TO THE IMPLANT RESULTING IN INCOMPLETE HARDENING OF THE LIQUID MONOMER. THERE IS NO EVIDENCE THAT USER ERROR CONTRIBUTED TO THIS COMPLAINT AS IN THE FOLLOW UP COMMUNICATION THE SALES REP STATED THAT DURING CURING THERE WAS NO VISIBLE DAMAGE TO THE LIGHT FIBER, AND NO ELEMENTS OF USER ERROR WERE OBSERVED BY THE SALES DISTRIBUTOR AND COMMUNICATED AS A PART OF THE COMPLAINT. IT IS POSSIBLE THAT THERE WAS INADVERTENT DAMAGE TO THE LIGHT FIBER WHICH WAS UNKNOWN TO THE USER AND THE SALES REP AS THE LIGHT FIBER RETURNED FOR INVESTIGATION WAS SEVERELY KINKED AND BROKEN. AS THE LIGHT BOX LIGHT OUTPUT WAS ELIMINATED AS A CAUSE, THE MOST LIKELY CAUSE IS INSUFFICIENT LIGHT TRANSMISSION OF THE LIGHT FIBER, MOST LIKELY DUE TO INADVERTENT DAMAGE DURING HANDLING AND USE. CONCLUSION: THE DEFINITIVE CAUSE OF THIS COMPLAINT IS UNKNOWN. THE MOST LIKELY CAUSE IS DUE TO INADVERTENT DAMAGE TO THE LIGHT FIBER DURING USE. THE LIGHT BOX USED IN THE CASE WAS RETURNED TO ILLUMINOSS AND THE LIGHT OUTPUT FOUND IN SPECIFICATION, THEREFORE THE PROPER AMOUNT OF LIGHT FROM THE LIGHT BOX TO THE LIGHT FIBER WAS PUT OUT. THE LIGHT FIBER RETURNED TO ILLUMINOSS WAS SIGNIFICANTLY DAMAGED, KINKED, AND BROKEN. WHILE THE REP STATED THE DAMAGE WAS NOT PRESENT DURING THE CASE, IT IS POSSIBLE THAT THE LIGHT FIBER DID SUSTAIN SOME DAMAGE PRIOR TO OR DURING CURING INADVERTENTLY AND IT WAS NOT NOTICED. DAMAGE TO THE LIGHT FIBER CAN REDUCE THE LIGHT TRANSMISSION FROM THE LIGHT BOX TO THE IMPLANT CAUSING UNDER CURING. THERE IS NO INDICATION THAT THE MONOMER CONTRIBUTED TO THE UNDER CURING BECAUSE THE LOT USED MET ALL ITS MATERIAL SPECIFICATIONS, AND NO OTHER COMPLAINTS FOR IMPLANTS IN THIS LOT (WHICH USE THE SAME MONOMER) HAVE BEEN RECEIVED FOR UNDER CURING. THEREFORE, WHILE THE DEFINITIVE CAUSE IS UNKNOWN, THE MOST LIKELY CAUSE IS DUE TO INADVERTENT DAMAGE TO THE LIGHT FIBER PRIOR TO OR DURING CURING REDUCING THE LIGHT TRANSMISSION AND CAUSING AN UNDER CURED IMPLANT. THIS IS CONSISTENT WITH THE COMPLAINT INFORMATION AS THE SECOND IMPLANT USED WITH THE SAME LIGHTBOX WAS REPORTED TO HAVE CURED WITHOUT INCIDENT.