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The following information was collected and analyzed: complaint detailed description (original (b)(6), as well as translated).Follow up questions and responses with complainant.Returned product (n/a - product was not returned).Photos (n/a - no photos provided).Radiographs (n/a - no photos provided).Validation testing of the product in question: tr-2056.Risk review performed using fmea-1002.J (implants), fmea-1004 (light box), & pms analysis through (b)(6) 2021.Manufacturing dhrs of the product in question.Review of the instructions for use for implant (ifu 900535 rev.B) and light curing system (ifu 900093 rev.S).Investigation details: a review of manufacturing records was performed both for the photodynamic bone stabilization system implant used, as well as the photodynamic light curing system used in conjunction with the implant.Testing of timer keys requires 100% inspection, which was performed and documented appropriately.The timer key packaged into this unit was confirmed to be the correct 500 second duration timer key as required per device specification for this size of implant, and as reflected in ifu 90535 rev.B.This review concludes that the devices met specification at the time of manufacturing, inspection, and release.(b)(6).The complaint product has not been returned for device evaluation, and no radiographs or photographs were provided to aid in the investigation.Review of validation testing: validation testing of the product in question was performed.Tr-2056 cure time validation for various sidefire balloons sizes includes the 9x160mm balloon size used in this case.This report concluded that cure time of at least 200 seconds will be sufficient to fully cure the liquid monomer within the 9mm diameter balloons with a length up to 200mm.Review of potential user errors that can result in this failure mode: follow-up questions were posed to the complainant to understand if any of the known user errors that can cause insufficient curing may have played a role in this case.In each instance, the complainant's response ruled out each potential user error that can result in insufficient curing.The clinic is one that is experienced with the illuminoss product and the proper technique for use of the device.Proper use of light box: it was reported that the light box used for the implant that didn't cure sufficiently is the same light box that had been used prior for other successful implants, and that it was used to cure the implant placed after the first implant was removed intraoperatively, which cured successfully.The complainant reported that between the first (insufficiently cured) implant and curing of the second (successful) implant with the same light box, they did not switch the light box off or perform any other system "re-setup" activities like unplug and then re-seat the light guide to the light box, which suggests that the light guide seating to the light box was not the cause of the insufficient curing.Wrong timer key used (not using the timer key provided with the implant): the complainant confirmed that the timer key used during the first (unsuccessful) implant was that which was provided with the delivery kit for that purpose (500 sec).Light fiber part of implant mishandled: the complainant reported that "implant preparation is done very carefully, both implants from the same nurse.She is doing almost every illuminoss case in agatharied.Even by placing it into the bone trough the sheath there was no bending or kinking.In summary, there is no evidence that user error contributed to this event.Ifu review: a review of instructions for use for this product for this market was performed ( 900535_b).The anatomy for which the implant was used is appropriate for the indications for this device in that market.Additionally, the ifu for the photodynamic light curing system was reviewed (900093_s).The photodynamic light curing system ifu (p/n 900093 rev s) includes set up and use instructions for the light box, including instructions for seating the light guide into the light box portal, and verification steps for proper functionality.Surgical technique guide 900428 rev.C includes the instruction to users to not let the device come into contact with other instruments or sharp objects prior to curing, as it can damage the device.Root cause analysis tool: the analysis tool used was rule in / rule out: confirmed: (b)(6).Incorrect attachment of light fiber to light guide: this potential cause can not be ruled out nor confirmed, as evaluation of the attachment at the time of the procedure was not possible.However, the implant hub is marked with an indicator arrow for the user to see the correct connection placement is made, the instructions for use include the step to verify this connection is correct, and this complainant is an experienced user of this product and with performing this step, therefore it is unlikely that this was the cause of the event.Discussion: although the "rule in/rule out" investigation technique allowed us to rule out many possible causes, the specific cause of this malfunction could not be determined with the information we were able to obtain.We were able to rule out a manufacturing cause through a review of the manufacturing records.A review of manufacturing records and complainant details about the case allowed us to conclude that the light box and light guide operated properly.Mis-handling of the light guide or user damage to the light fiber is unlikely as a cause of this event, as the surgeon and or staff of this clinic are very experienced with illuminoss product and reported they practice very careful preparation steps for this device, and that they did not see any kinks or disturbances of the light fiber.Therefore we are unable to identify a probably cause for this event with the information we were able to obtain.Conclusion: given the information presented above, it is not possible to identify root cause.Therefore, the investigation has determined that the cause is unknown.
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During treatment of a traumatic fracture of the distal radius, the doctor placed and cured an illuminossphotodynamic bone stabilization system 9 x 160 implant.When the curing time was over, it was discovered that the implant had not cured over its full length.Dr.(b)(6) had treated a distal radius fracture with an implant ml-09160 and lot 390775.He has treated many cases already.The implant was inserted without any problems.When the curing time was over it was discovered, that the implant had not cured over its full length.It has been removed and replaced by another implant of the same size.This second implant cured properly.The patient outcome was reported as good.The additional surgical time required to remove and replace the insufficiently cured implant was approximately 70 minutes.
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