PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

PENDING ADDTIONAL INFORMATION AND INVESTIGATION.

Description of Event or Problem

THE REP STATED THAT WHEN THE SURGEON TRIED TO INFUSE THE IMPLANT WITH MONOMER, HE WAS UNABLE TO APPLY PRESSURE TO THE SYRINGE HANDLE AND COULD NOT GET ANY MONOMER INTO THE BALLOON. ACCORDING TO THE REP, THE PREPPED IMPLANT HAD NOT BEEN EXPOSED TO LIGHT AT ANY POINT. THEY THEN REMOVED THE IMPLANT FROM THE CANAL AND USED A NEW ONE. THE SECOND IMPLANT WAS PREPPED USING THE MONOMER SYRINGE FROM THE FIRST ATTEMPT, BUT WHEN TRYING TO APPLY THE MONOMER, THE SURGEON STATED THAT THE SYRINGE WAS CURING AND AGAIN COULD NOT INFUSE THE BALLOON. THE SECOND IMPLANT WAS REMOVED AND DISCARDED. THEY THEN TRIED A THIRD BALLOON FROM A NEW IMPLANT KIT, WHICH WAS SUCCESSFUL WITH NO ISSUES.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION: IT IS A KNOWN RISK THAT IF A PREPPED IMPLANT OR SYRINGE FILLED WITH MONOMER IS EXPOSED TO LIGHT, THE MONOMER CAN POLYMERIZE AND HARDEN, RESULTING IN A SYRINGE AND IMPLANT WHICH ARE UNABLE TO INFUSE MONOMER AS THE MONOMER PATHWAY HAS BEEN BLOCKED BY HARDENED MONOMER. A WARNING TO SHIELD MONOMER FROM LIGHT AFTER REMOVAL FROM THE VIAL IS INCLUDED IN THE IFU (900356_X). THE STG 900510_E ALSO STATES, "NOTE: ONCE THE IMPLANT HAS BEEN PREPARED FOR USE, AND THE CATHETER PRIMED WITH MONOMER, IT SHOULD BE IMMEDIATELY DELIVERED TO THE SURGICAL SITE. IF THE IMPLANT IS PREPARED PRIOR TO USE, ENSURE THAT THE ENTIRE IMPLANT AND ATTACHED SYRINGE IS COVERED WITH A STERILE DRAPE OR OTHER STERILE MATERIAL TO PREVENT LIGHT FROM COMING IN CONTACT WITH THE IMPLANT AND OR SYRINGE." THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THAT AFTER THE IMPLANT WAS PRIMED WITH MONOMER, IT WAS INADVERTENTLY EXPOSED TO LIGHT, WHICH POLYMERIZED THE MONOMER IN THE BALLOON CATHETER, BLOCKING THE PATHWAY WHICH MORE MONOMER WOULD BE INFUSED THROUGH. THIS RESULTED IN THE USER BEING UNABLE TO INFUSE MORE MONOMER INTO THE IMPLANT. A SECOND IMPLANT WAS PREPPED, AND THE USER USED THE SAME SYRINGE FROM THE FIRST IMPLANT, AND STATED THE SYRINGE WAS CURING AND AGAIN COULD NOT INFUSE THE BALLOON. THE REP STATED THAT THE REMAINING MONOMER FROM THE FIRST IMPLANT WAS NOT PROTECTED FROM LIGHT. AGAIN, IT IS MOST LIKELY THAT THE SYRINGE FROM THE FIRST BALLOON FILLED WITH MONOMER WAS INADVERTENTLY EXPOSED TO LIGHT AND THE MONOMER STARTED TO POLYMERIZE AND PREVENT MONOMER FROM BEING PUSHED FROM THE SYRINGE, PREVENTING THE USER FROM INFUSING THE SECOND IMPLANT. THE IFU 900356_X STATES "DO NOT REUSE OR ATTEMPT TO RE-STERILIZE THE DISPOSABLE COMPONENTS" SO THE USER SHOULD HAVE DISCARDED THE SYRINGE AND MONOMER FROM THE FIRST IMPLANT, AND ONLY USED THE DISPOSABLE COMPONENTS FROM THE SECOND IMPLANT KIT. WHILE THE REP STATED THAT THE PREPPED IMPLANT WAS NOT EXPOSED TO LIGHT AT ANY POINT, IT IS MOST LIKELY THAT THE USER WAS UNAWARE THAT THE IMPLANT HAD INADVERTENTLY BEEN EXPOSED TO LIGHT. THE REP PRESENT AT THE CASE STATED THAT THE IMPLANT WAS PREPPED JUST BEFORE IT WAS NEEDED AND THEN HANDED TO THE SURGEON. THE REMAINING MONOMER WAS NOT PROTECTED FROM LIGHT BUT WAS ATTEMPTED TO BE USED WITHIN 1 MINUTE. THEREFORE, THE MONOMER WAS MOST LIKELY INADVERTENTLY EXPOSED TO LIGHT WITHIN THIS TIME. EACH BALLOON CATHETER ASSEMBLY IS PRESSURE LEAK TESTED AS THE FINAL RELEASE CRITERIA PER WIS-1024. IF A BALLOON CATHETER ASSEMBLY HAD THE MONOMER PATHWAY OCCLUDED, IT WOULD FAIL THE PRESSURE LEAK TEST AND NOT BE RELEASED. THE DHR OF THE IMPLANT KITS SHOW THAT ALL ASSEMBLIES IN THE LOTS WHICH WERE RELEASED PASSED THE LEAK TEST, AND THUS THE PATHWAY WHICH MONOMER IS INFUSED INTO WAS NOT OCCLUDED UPON PRODUCT RELEASE. FURTHER, THE FIRST STEP WHEN PREPPING A BALLOON CATHETER ASSEMBLY IS TO REMOVE THE AIR AND DRAW A VACUUM IN THE ASSEMBLY. IF THE INFUSION PATHWAY WAS OBSCURED, THE USER WOULD NOT BE ABLE TO DRAW A VACUUM IN THE ASSEMBLY, AND THERE WERE NO NOTED CHALLENGES WITH THIS STEP IN THE COMPLAINT DESCRIPTION. THEREFORE, THE CAUSE OF THE INABILITY TO INFUSE MONOMER INTO THE BALLOON CATHETER ASSEMBLY WAS DUE TO INADVERTENT EXPOSURE OF THE MONOMER ONCE OUT OF THE VIAL TO LIGHT, CAUSING IT TO POLYMERIZE AND HARDEN, BLOCKING THE INFUSION PATHWAY. DHR REVIEW: THE DHR OF BOTH IMPLANTS WHICH WERE UNABLE TO BE INFUSED WERE REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. ALL IMPLANT SUB ASSEMBLIES IN THE LOTS WHICH WERE RELEASED PASSED THEIR FINAL PRESSURE LEAK TEST WHICH DEMONSTRATES THAT AT THE TIME OF MANUFACTURE AND RELEASE THE MONOMER INFUSION PATHWAY WAS OPEN. AIR IS USED TO CREATE PRESSURE AND VACUUM IN THE BALLOON CATHETER ASSEMBLY MONOMER PATHWAY AND BALLOON DURING THE PRESSURE LEAK TEST, AND THIS TEST WOULD NOT PASS IF THE MONOMER PATHWAY WAS OBSTRUCTED BECAUSE THEN THE AIR COULD NOT PASS THROUGH TO MEET THE REQUIRED PRESSURE/VACUUM SPECIFICATIONS OF THIS TEST. RETURNED PRODUCT EVALUATION: N/A NO RETURNED PRODUCT AVAILABLE. THE DEVICES WERE DISCARDED IN THE OR. IFU REVIEW: A WARNING TO SHIELD MONOMER FROM LIGHT AFTER REMOVAL FROM THE VIAL IS INCLUDED IN THE IFU (900356_X). THE STG 900510_E ALSO STATES, "NOTE: ONCE THE IMPLANT HAS BEEN PREPARED FOR USE, AND THE CATHETER PRIMED WITH MONOMER, IT SHOULD BE IMMEDIATELY DELIVERED TO THE SURGICAL SITE. IF THE IMPLANT IS PREPARED PRIOR TO USE, ENSURE THAT THE ENTIRE IMPLANT AND ATTACHED SYRINGE IS COVERED WITH A STERILE DRAPE OR OTHER STERILE MATERIAL TO PREVENT LIGHT FROM COMING IN CONTACT WITH THE IMPLANT AND OR SYRINGE." THE IFU 900356_X ALSO STATES "DO NOT REUSE OR ATTEMPT TO RE-STERILIZE THE DISPOSABLE COMPONENTS." THE APPROPRIATE INSTRUCTIONS AND WARNINGS AGAINST THIS USE ERROR ARE INCLUDED IN THE IFU AND STGS. POTENTIAL FOR USER ERROR: INADVERTENT EXPOSURE TO LIGHT OF THE PRIMED IMPLANT AND SYRINGE FILLED WITH MONOMER CAUSED THE INABILITY TO INFUSE MONOMER INTO THE IMPLANT, AND REUSE OF THE SYRINGE FROM THE FIRST IMPLANT KIT FILLED WITH MONOMER AFTER INADVERTENT EXPOSURE TO LIGHT WITH THE SECOND IMPLANT KIT CAUSED THE SECOND IMPLANT KIT USED TO UNABLE TO INFUSED WITH MONOMER AS WELL. THE ILLUMINOSS EMPLOYEE WHO SUBMITTED THE COMPLAINT STATED THAT HE DISCUSSED WITH THE REP PRESENT IN THE CASE THAT IF THIS OCCURRED AGAIN, TO NOT USE MONOMER FROM THE PREVIOUS SYRINGE, AND TO START WITH A NEW IMPLANT KIT, AS STATED IN THE IFU "NO NOT REUSE OR ATTEMPT TO RE-STERILIZE THE DISPOSABLE COMPONENTS". CONCLUSION: THE CAUSE OF THE COMPLAINT WAS DUE TO INADVERTENT USER ERROR IN WHICH A PRIMED IMPLANT AND SYRINGE FILLED WITH MONOMER WERE EXPOSED TO LIGHT PRIOR TO USE, CAUSING THE MONOMER TO BE UNABLE TO BE INFUSED INTO THE IMPLANT. USER ERROR ALSO CONTRIBUTED TO THE SECOND IMPLANT BEING UNABLE TO BE INFUSED BECAUSE THE SYRINGE FILLED WITH MONOMER FROM THE FIRST IMPLANT WAS ATTEMPTED TO BE REUSED, INSTEAD OF DISCARDED AND ALL DISPOSABLES FROM THE SECOND IMPLANT KIT USED, AND AS THE SYRINGE FILLED WITH MONOMER WAS INADVERTENTLY EXPOSED TO LIGHT, THE MONOMER BEGAN TO POLYMERIZE AND PREVENTED INFUSION OF MONOMER INTO THE SECOND IMPLANT. THEREFORE, TWO INSTANCES OF USER ERROR (NOT PROTECTING THE MONOMER FROM LIGHT AFTER REMOVAL FROM THE VIAL AND REUSE OF A DISPOSABLE ACCESSORY) CAUSED THIS COMPLAINT.

Description of Event or Problem

THE REP STATED THAT WHEN SURGEON TRIED TO INFUSE THE IMPLANT WITH MONOMER, HE WAS UNABLE TO APPLY PRESSURE TO THE SYRINGE HANDLE AND COULD NOT GET ANY MONOMER INTO THE BALLOON. ACCORDING TO THE REP, THE PREPPED IMPLANT HAD NOT BEEN EXPOSED TO LIGHT AT ANY POINT. THEY THEN REMOVED THE IMPLANT FROM THE CANAL AND USED A NEW ONE. THE SECOND IMPLANT WAS PREPPED USING THE MONOMER SYRINGE FROM THE FIRST ATTEMPT, BUT WHEN TRYING TO APPLY THE MONOMER, THE SURGEON STATED THAT THE SYRINGE WAS CURING AND AGAIN COULD NOT INFUSE THE BALLOON. THE REMAINING MONOMER IN THE SYRINGE FROM THE FIRST IMPLANT WAS NOT PROTECTED FROM LIGHT WHILE THE SECOND BALLOON WAS PREPPED. THE SECOND IMPLANT WAS REMOVED AND DISCARDED. THEY THEN TRIED A THIRD BALLOON FROM A NEW IMPLANT KIT WITH THE NEW MONOMER FROM THE THIRD IMPLANT KIT, WHICH WAS SUCCESSFUL WITH NO ISSUES. THE SURGICAL DELAY EXPERIENCED DUE TO OBTAINING AND PREPPING NEW IMPLANTS WAS APPROXIMATELY 15-20 MINUTES.