PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS PENDING FURTHER INFORMATION.

Description of Event or Problem

BALLOON WAS INSERTED INTO THE PATIENT. THE LIGHT BOX WAS TURNED ON, HAD A BEEPING SOUND AND WOULD NOT TURN ON CORRECTLY. THE BALLOON WAS REMOVED WHEN THE LIGHT BOX ISSUE OCCURRED AND THE SURGEON USED A DIFFERENT SOLUTION FOR FIXATION.

Additional Manufacturer Narrative

A CORRECTION WAS MAD TO THE DATE OF THE EVENT AND THE CATALOGUE NUMBER PERTAINING TO THE COMPLAINT. ROOT CAUSE INVESTIGATION; FOLLOW UP INFORMATION: THE DISTRIBUTOR PRESENT IN THE CASE STATED THAT THERE WERE NO VISIBLE BREAKS, KINKS OR DAMAGE TO THE LIGHT FIBER AND HE DID NOT WITNESS THE LIGHT FIBER CONTACT ANY SHARP OBJECTS. HE NOTED THAT THE DISTRIBUTORS PRESENT AND THE SURGEON NOTICED A POINT MIDWAY ALONG THE LIGHT FIBER IN WHICH THE LIGHT BEING ILLUMINATED VISIBLY DIMMED. THE SURGEON NOTED IT SEEMED LIKE THERE WAS A KINK AT THIS LOCATION ALONG THE LIGHT FIBER DUE TO THE VISIBLE CHANGE IN LIGHT BRIGHTNESS ALONG THE LIGHT FIBER, BUT THERE WAS NO VISIBLE KINK THEY COULD SEE. THE DISTRIBUTOR ALSO STATED THAT THERE WAS NOTHING VISIBLY WRONG WITH THE END OF THE LIGHT FIBER OR THE GOLD LIGHT HUB CONNECTOR. THE LIGHT BOX WORKED PROPERLY, BECAUSE AFTER THE UNDER CURED IMPLANT WAS REMOVED, A NEW IMPLANT WAS PLACED AND THE LIGHT FIBER CURED WITH THE SAME LIGHT BOX AND IT WAS NOTABLY BRIGHTER. DHR REVIEW: THE DHR OF LOT 440699 WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. ALL LIGHT FIBER ASSEMBLIES USED IN THIS LOT PASSED THE LIGHT FIBER INSPECTION TEST, DEMONSTRATING THE LIGHT OUTPUT WAS IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE DHR OF LIGHT BOX SN (B)(6) WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE LIGHT OUTPUT OF THE LIGHT BOX AND LIGHT GUIDE WAS 366 MW/CM2 WHICH IS IN SPECIFICATION. RETURNED PRODUCT EVALUATION: THE IMPLANT WAS DISCARDED IN THE OR AND NOT ABLE TO BE RETURNED. IFU REVIEW: IFU 900356_X STATES: THE MONOMER MUST BE EXPOSED TO THE ILLUMINOSS PHOTODYNAMIC CURING SYSTEM FOR A SPECIFIC AMOUNT OF TIME IN ORDER TO ACTIVATE AND FULLY CURE THE IMPLANT. SPECIFIC INSTRUCTIONS PROVIDED TO USER TO AVOID KINKING OR DAMAGING THE LIGHT FIBER BY CLAMPING OR CONTACTING WITH INSTRUMENTS, IN SURGICAL TECHNIQUE GUIDE 900477, 900510, 900523, 900524, 900598, 900602, 900604, 900611, 900780. POTENTIAL FOR USER ERROR: THERE IS NO EVIDENCE THAT USER ERROR CAUSED THE COMPLAINT, HOWEVER INADVERTENT DAMAGE TO THE LIGHT FIBER BY THE USER CANNOT BE RULED OUT. THE DISTRIBUTOR STATED THERE WAS NO VISIBLE KINK OR DAMAGE TO THE LIGHT FIBER AND IT DID NOT CONTACT ANY SHARP OBJECTS. HOWEVER, BOTH THE DISTRIBUTOR AND USER OBSERVED A POINT ALONG THE LENGTH OF THE FIBER WHERE THE LIGHT OUTPUT FROM THE FIBER VISIBLY DIMMED, WHICH SUGGESTS A POINT OF DAMAGE RESULTING IN LESS LIGHT OUTPUT. IT IS POSSIBLE THAT THE LIGHT FIBER WAS INADVERTENTLY KINKED AND THEN STRAIGHTENED BACK OUT, RESULTING IN THE OBSERVED CHANGE IN LIGHT INTENSITY ALONG THE MIDSECTION OF THE LIGHT FIBER. CONCLUSION: THE MOST LIKELY CAUSE IS THE LIGHT FIBER WAS INADVERTENTLY KINKED DURING USE, RESULTING IN A DECREASE IN THE LIGHT TRANSMITTED FROM THE LIGHT BOX TO THE MONOMER AND THE UNDER CURED IMPLANT. AS THE LIGHT FIBER WAS DISCARDED AND NOT RETURNED FOR EVALUATION, AND THE DISTRIBUTOR PRESENT IN THE CASE COULD NOT VISUALLY SEE ANY KINKS OR DAMAGE TO THE LIGHT FIBER, THE DEFINITIVE ROOT CAUSE IS UNKNOWN.

Description of Event or Problem

AN IMPLANT WAS INSERTED AND CURING STARTED, AND THE REPS NOTICED THAT THE BLUE LIGHT BEING EMITTED FROM THE LIGHT FIBER WAS NOT THE USUAL BRIGHT BLUE COLOR. BASED ON THIS, IT WAS THOUGHT THAT THE BALLOON DID NOT FULLY CURE, SO THE SURGEON CUT THE CATHETER AFTER THE CURING WAS OVER AND THE MONOMER STARTED SPILLING OUT. THE SURGEON PULLED THE BALLOON OUT AND REMOVED THE MONOMER, THE BALLOON REMAINED IN ONE PIECE. A NEW IMPLANT WAS INSERTED AND CURED WITH THE SAME LIGHT BOX AND THIS TIME THE LIGHT FIBER WAS BRIGHT BLUE AND THE IMPLANT FULLY CURED. THERE WAS A 50 MINUTE SURGICAL DELAY DUE TO THE CURING FAILURE.

Description of Event or Problem

BALLOON WAS INSERTED INTO THE PATIENT. THE LIGHT BOX WAS TURNED ON, HAD A BEEPING SOUND AND WOULD NOT TURN ON CORRECTLY. THE BALLOON WAS REMOVED WHEN THE LIGHT BOX ISSUE OCCURRED AND THE SURGEON USED A DIFFERENT SOLUTION FOR FIXATION.

Additional Manufacturer Narrative

THE INVESTIGATION IS PENDING FURTHER INFORMATION AS OF THE DATE OF THIS REPORT

Additional Manufacturer Narrative

DHR REVIEW: THE DHR FOR THE LIGHT BOX SN: (B)(6) WAS REVIEWED AND THE LIGHTBOX WAS FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE LIGHT BOX WAS MANUFACTURED BY THE SUPPLIER BETWEEN DECEMBER 2019 AND JANUARY 2020 AND PASSED ALL SPECIFICATIONS. THE LIGHT BOX WAS PAIRED WITH LIGHT GUIDE SN (B)(6) AND TESTED PRIOR TO RELEASE AND MET ALL SPECIFICATIONS. THE LIGHT BOX WAS ABLE TO BE ACTIVATED AND TURN ON PROPERLY AT THE TIME OF MANUFACTURING INSPECTION. FURTHER, THE LIGHT BOX OUTPUT AND LIGHT GUIDE OUTPUT WERE INSPECTED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURING INSPECTION AND RELEASE 31 JULY 2020. SEE ATTACHMENT B FOR FULL DHR. RETURNED PRODUCT EVALUATION: THE LIGHT BOX WAS RETURNED TO ILLUMINOSS AND EVALUATED ON 09 AUG 2024. THE LIGHT BOX AND ACCESSORIES APPEARED UNDAMAGED. THE LIGHT GUIDE WAS PAIRED CORRECTLY WITH ITS LIGHT BOX AS EXPECTED AND NO DEBRIS OR DAMAGE INSIDE THE LIGHT GUIDE WAS OBSERVED. THE LIGHT BOX WAS PLUGGED IN AND POWERED ON AS EXPECTED. THE BULB CHANGE LIGHT WAS NOT ILLUMINATED AND THE SYSTEM READY LIGHT ILLUMINATED WITHIN 7 MINUTES OF POWERING ON SYSTEM. THE FOOT PEDAL WAS PLUGGED IN, AND THE STANDBY SWITCH SET TO FOOT PEDAL ENGAGED. WHEN THE FOOT PEDAL WAS PRESSED THE LIGHT ACTIVATED AS EXPECTED. THE LIGHT BOX WAS SUCCESSFULLY SET UP AND THE TIMER KEY SCREEN DISPLAYED THE CORRECT TIME UPON PROPER INSERTION OF TIMER KEY. THE TIMER OF LIGHT BOX WAS SUCCESSFULLY RESET WHEN THE TIMER KEY REMOVED AND RESEATED DURING COUNTDOWN. HOWEVER, THE LIGHT OUTPUT OF THE LIGHT BOX WAS FOUND TO BE 11.1 W/CM2 WHICH IS BELOW THE ACCEPTANCE CRITERIA (14.0-20.9 W/CM2 ) AND THE LIGHT OUTPUT OF THE LIGHT GUIDE WAS 188 MW/CM2 WHICH IS BELOW THE ACCEPTANCE CRITERIA (224 - 400 MW/CM2). PER FORM F-1034 REV C, IF THE LIGHT BOX OUTPUT WAS FOUND TO BE BELOW THE ACCEPTANCE CRITERIA, IT REQUIRES TO REPLACE THE BULB AND FOLLOW WIS-100044 OR WIS-100131. THE LIGHTBOX WAS THEN SENT TO THE SUPPLIER FOR FURTHER EVALUATION. THE SUPPLIER IDENTIFIED A LOOSE SCREW INSIDE THE UNIT. THE COMPLAINANT STATED HE HEARD A NOISE SOUND WHEN HE STARTED THE LIGHT BOX, SO IT IS MOST LIKELY THAT THIS SCREW WAS LOOSE DURING THE TIME OF THE COMPLAINT. THE LOOSE SCREW WAS IDENTIFIED TO BE A SCREW USED TO MOUNT THE PHOTOSENSOR BOARD ASSEMBLY NEAR THE SHUTTER FOR THE LAMP AND SHOULD BE THREADED INTO THE BLACK DELRIN MOUNTING BLOCK (A FORM OF PLASTIC), HOWEVER, IT WAS FOUND LOOSE ON THE BOTTOM OF THE LAMP SIDE OF THE LIGHT BOX WHICH CAUSED THE PHOTOSENSORS TO BE MISALIGNED. THIS SUGGESTS THAT THIS LOOSE SCREW COULD HAVE CAUSE THE STARTUP ERROR OBSERVED IN THE COMPLAINT. THE MOST LIKELY CAUSE OF THE SCREW BECOMING WORKED LOOSE IS DUE TO VIBRATION/SHOCK/MOVEMENT OF THE LIGHT BOX DUE TO SHIPPING AND HANDLING. THERE IS EVIDENCE THAT THE LIGHT BOX EXPERIENCED A LOT OF TRANSPORT AS EVIDENT BY ALL OF THE STICKERS FROM DIFFERENT HOSPITALS ON TOP OF THE UNIT. THE LAMP IN THE UNIT WAS EVALUATED AS WELL BY THE SUPPLIER. THE LAMP WAS IDENTIFIED TO BE DIFFICULT TO IGNITE AND APPEARED TO BE BEYOND ITS USEFUL LIFE DUE TO THE AGE OF THE LAMP AND THE LIGHT GUIDE (UV) OUTPUT WAS MEASURED TO BE LOW (OUT OF SPECIFICATION). THE LIGHT BOX HAS A BUILT-IN TIMER THAT IS TRIGGERED AT 500 HOURS AND CAUSES BEEPING UPON START-UP AND PROHIBITS LAMP IGNITION ALTHOUGH THE 500-HOUR LIGHT WAS NOT ON FOR THE UNIT. THEORETICALLY, IF THE 500-HOUR LIGHT TURNED ON, A USER OR SALE REPS CAN RE-SET THE 500-HOUR LIGHT BOX TIMER TO TURN OFF THIS LIGHT WITHOUT REPLACING THE LIGHT BULB. HOWEVER, THE INSTRUCTIONS TO RESET THE TIMER ARE NOT PROVIDED TO USERS OR SALES REPS AND THE IFU INSTRUCTS THE USER TO RETURN THE LIGHT BOX TO ILLUMINOSS IF THIS 500-HOUR TIMER LIGHT TURNS ON. THE IFU 900368_G STATES, "BULB REPLACEMENT[?]RETURN THE UNIT TO ILLUMINOSS FOR BULB REPLACEMENT WHEN THE INDICATOR LIGHT STARTS FLASHING." THE POTENTIAL FOR THIS TO HAVE OCCURRED HAS BEEN ELIMINATED BECAUSE THE SALES REP DESCRIBED WHAT HAPPENED AT THE TIME OF THE PROCEDURE AND HE DID NOT STATE THE 500-HOUR LIGHT TURNED ON OR HE ATTEMPTED TO RESET THE TIMER, AND THE INSTRUCTIONS FOR PERFORMING THE TIMER RESET ARE NOT PROVIDED TO THE USERS OR SALES REPS. IF THE SALE REP RE-SET THE TIMER WITHOUT SENDING THE UNIT TO CHANGE THE BULB, THIS WOULD HAVE BEEN INCLUDED IN THE FOLLOW-UP DISCUSSION (SEE ATTACHMENT D). BOTH TYPES OF MALFUNCTIONS (LOOSE SCREW AND AGE OF LAMP) WOULD NORMALLY CAUSE A BEEP TO BE HEARD, AND THE COMPLAINT WAS REPORTED AS A BEEP BEING HEARD, AND THE LIGHTBOX WOULD NOT TURN ON CORRECTLY. VALIDATION REVIEW SHIP TESTING OF THE LIGHT BOX 75VT HAS BEEN PERFORMED WHICH DEMONSTRATED NO ADVERSE EFFECTS OF CONDITIONING, DROP TESTING, VIBRATION TESTING, OR COMPRESSION TESTING WERE NOTED, WITH EXCEPTION OF EXTERIOR BOX AESTHETICS. BOTH UNITS PASSED ALL FUNCTIONAL TESTING, AND NO INTERNAL COMPONENTS WERE DAMAGED, REF: TR-2170- SHIPPING VALIDATION OF LIGHT BOX 75 VT, ASTM D4169-09. LIGHTBOX 500-HOUR FIRMWARE VALIDATION OF 75 VT LIGHT BOX HAS BEEN PERFORMED TO SHOW THAT THE DESIGN, WHICH AT 450 HOURS OF BULB LIFE, IS SET TO "FLASH" THE CHANGE BULB INDICATOR TO WARN THE USER OF IMPENDING END OF USEFUL LIFE PERFORMS AS INTENDED. THE DESIGN THAT AT 500 HOURS OF BULB LIFE, KEEPS THE CHANGE BULB INDICATOR ON TO WARN USER BULB HAS REACHED END OF USEFUL LIFE AND TO CHANGE BULB AS SOON AS POSSIBLE OR UPON COMPLETION OF PROCEDURE AS PERFORMS AS INTENDED. THE LIGHT BOX WILL BECOME INOPERABLE AFTER RESTART OR COMPLETION OF PROCEDURE, REF: (B)(4): LIGHTBOX 500 HOUR FIRMWARE VALIDATION. THE LIGHT BULB DECAY WAS ALSO TESTED IN REP-1008 WHICH DEMONSTRATED EFFECTIVE PERFORMANCE OVER THE ANTICIPATED USEFUL LIFE OF 2000 "ON" HOURS. IFU REVIEW AND POTENTIAL FOR USER ERROR. THE IFU 900368_G STATES TO SET-UP AND ACTIVATE THE PHOTODYNAMIC CURING SYSTEM PRIOR TO THE START OF ANY SURGICAL PROCEDURE USING THE ILLUMINOSS IMPLANT TO ENDURE PROPER EQUIPMENT OPERATION AS DESCRIBED IN THIS MANUAL. DO NOT USE THE SYSTEM OR IMPLANT IF ANY OF ITS COMPONENTS ARE DAMAGED OR NOT OPERATING PROPERLY AND CONTACT ILLUMINOSS MEDICAL FOR SERVICE OR REPLACEMENT. THIS IFU ALSO STATES THE PROPER SET UP AND OPERATION OF THIS PHOTODYNAMIC CURING SYSTEM WILL MAXIMIZE SAFETY AND PERFORMANCE. IFU 900356_X ALSO STATES RISKS INCLUDE MALFUNCTION OF THE PHOTODYNAMIC PROCESS. POTENTIAL FOR USER ERROR AS THE IFU INSTRUCTS THE USER TO SET-UP AND ACTIVATE THE CURING SYSTEM PRIOR TO THE START OF ANY SURGICAL PROCEDURE, AND THIS WAS NOT FOLLOWED FOR THIS CASE, THERE IS AN ELEMENT OF USER ERROR. IF THE LIGHT BOX WAS SETUP AND ACTIVATED PRIOR TO THE CASE, THEN THE FAILURE WOULD LIKELY BE RECOGNIZED PRIOR TO THE START OF THE CASE, AND PER THE IFU IF THE CURING SYSTEM DOES NOT OPERATE PROPERLY, DO NOT USE THE SYSTEM OR IMPLANT. AS THESE INSTRUCTIONS WERE NOT FOLLOWED AND THE LIGHT BOX WAS NOT SET UP AND ACTIVATED PRIOR TO THE PROCEDURE, THE BALLOON WAS REMOVED FROM THE PATIENT AND A DIFFERENT SOLUTION WAS USED FOR FIXATION. CONCLUSION: THE LIGHT BOX FAILURE WAS DUE TO EITHER A LOOSE SCREW, CAUSING MISALIGNMENT OF THE PHOTOSENSOR AND A STARTUP ERROR DUE TO VIBRATION/SHOCK/MOVEMENT OF THE LIGHT BOX DUE TO SHIPPING AND HANDLING, AND/OR THE AGE OF THE LAMP BEING BEYOND THE USEFUL LIFE, WHICH CAUSES BEEPING UPON START-UP AND PROHIBITS LAMP IGNITION.

Description of Event or Problem

BALLOON WAS INSERTED INTO THE PATIENT. THE LIGHT BOX WAS TURNED ON, HAD A BEEPING SOUND AND WOULD NOT TURN ON CORRECTLY. THE BALLOON WAS REMOVED WHEN THE LIGHT BOX ISSUE OCCURRED AND THE SURGEON USED A DIFFERENT SOLUTION FOR FIXATION.