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Given the information reviewed within this investigation, the most probable root cause is unintentional misuse: not seating the light fiber fully within the light guide gold connector prior to curing.Context: the device in question is an intramedullary balloon catheter (ibc) that is part of the illuminoss photodynamic bone stabilization system (pbss).It is a formed-in-place intramedullary implant used to stabilize bone fractures.The ibc consists of a balloon attached to a catheter and y-body assembly that allows the user to infuse monomer material into the balloon, and to fill it once it is in the intramedullary canal and placed across the fracture site.The catheter and y-body also allow access for the light fiber into the balloon which provides the light necessary to harden the monomer into a polymer.The light fiber is connected outside the sterile field to a light source (light box) via a light guide.The light source is activated using a timer key provided with the pbss implant and delivery system, and when activated emits visible light that cures the monomer filled balloon in-situ, resulting in a permanent implant.Manufacturing record review: a review of manufacturing records for this pbbs lot, associated components, light box, and light guide was performed.Records indicate that the products met manufacturing specifications at the time of product release.The manufacturing record for the pbbs implant was verified to have the correct light box timer key provided with the pbss delivery system.Ifu review: this treatment (pelvis, in the us) was on label per the indications for use per ifu 900356.Surgical technique guide 900510 includes set up and use instructions for the light box and handling instruction when attaching the light fiber to the light guide.Returned product evaluation: the implant and delivery system could not be evaluated, as they were discareded at the hospital and not returned to the manufacturer.The light box and light guide were returned at the manufacturer's request, and product evaluation was performed per f-1034 light box inspection.The light output requirements were verified.All test results met specifications.No product problem was found.Additional in-house simulation test - light fiber attachment to light guide a photo of the light guides attached to the two implants during the curing process was provided by the company representative from the time of the event.This showed a distinct difference in the light intensity between the two light fibers.Insufficient light intensity can lead to insufficient curing, therefore additional in-house testing was performed.As the light box and light guide were found to be performing within specification, and no evidence of light fiber kinking or damage was observed by the reporting physician or visible in the photograph provided, in-house simulation was performed of a possible mis-handling issue with the connection between the light fiber and the light guide.The test used a light box, a light guide, and a 260mm light fiber that did not contain any kinks or damaged areas leaking light.This equipment was used to demonstrate whether a significant difference in light intensity occurs when the light fiber is not correctly inserted into the light guide.The light system was activated and allowed to warm up per procedure.Once it was ready, the timer key was inserted and the light box was activated.Results of light fiber correctly attached: the light fiber was inserted into the light guide as specified in ifu.The light box was activated, turning the light fiber bright blue along its entire length.Results of light fiber incorrectly attached: while the light box was still activated and producing light, the light fiber was pulled from the light guide approximately 1mm to simulate an incorrectly attached light fiber.The light fiber appeared dim along its entire length.Conclusion of simulation test: based on the results from the simulation test, we were able to replicate the reported failure mode by incorrectly attaching the light fiber to the light guide, which led to a reduced amount of light emitted through the fiber.This cause can lead to an incomplete cure of the implant.Misuse: a possible misuse cause for insufficient curing of the monomer relates to set up and handling of the light fiber, including kinking the light fiber, damaging the light fiber by clamping or contacting with instrument, etc.These were less likely causes in this event, as the surgeon reported that he could not see "any kinks or disturbances in the light fiber." another potential misuse cause for insufficient curing of the monomer relates to the incorrect attachment of light fiber to the light guide: this potential cause can not be ruled out nor confirmed, as illuminoss evaluation of the system set up at the time of the procedure was not performed.However, this cause of the reported failure mode was successfully re-created in an in-house simulation test, and is a possible cause.Discussion regarding possible causes listed above: following a "rule in/rule out" investigation technique, we identified that light fiber or light guide mis-handling was the likely cause of this event.We were able to rule out a manufacturing cause through a review of the manufacturing records.The light box and light guide were returned and product evaluation was performed, concluding that there was no device problem found with the light box and light guide.When simulated mis-handling of the light fiber to light guide connection was performed, the failure mode was able to be re-created.Although mis-handling/user damage to the light fiber is a possible cause we could not entirely rule out, it is a less likely cause of this event, as the surgeon (very experienced with illuminoss product) and the company representative who were present visually inspected the light fiber prior to use and reported they did not see any kinks or disturbances of the light fiber.Therefore the most probable root cause is determined to be the light guide not fully seated within portal in light box (unintentional misuse).Conclusion: given the information presented above, the most probable root cause is determined to be the light fiber not fully seated within the light guide gold connector.(unintentional misuse).
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During treatment for tibia orif - pelvic tumors - r.Hip arthroplasty on (b)(6) 2021, a company representative reported that (b)(6) experienced the following event: (b)(6) was performing open reduction and internal fixation for a (b)(6) old metastatic female patient, in which he intended to use 2 of the 22/13x160mm illuminoss photodynamic bone stabilization system implants in the pelvis.Both the surgeon and the company representative noticed that one of the light fibers was not as bright as the other during the curing process, but neither observed any kinks or disturbances to the light fiber.After curing, (b)(6) proceeded with the planned treatment by drilling into the implants, and found that one implant had cured successfully, but the other had not sufficiently cured (physician estimates it had cured to ~65%).Note: the first implant that had cured successfully remains in the patient.The treating physician removed the insufficiently cured implant inter-operatively and completed the procedure using an alternative fixation method (cement to fill the canal and complete the hip arthroplasty), which introduced an estimated additional 45 minutes to the overall 7 hour duration of the entire procedure (including tibial carbo fix plate, an illuminoss pelvic implant and a stryker hip replacement).Patient outcome was satisfactory.
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