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On 25 january 2021, dr.(b)(6) used an illuminoss photodynamic bone stabilization sysmte in a pelvic case.After the timeout of the lightbox, he noticed that the monomer filled implant was not cured.He removed the implant and replaced it with another one.It worked well.There was an error in the handling of the device and therefore it had to be exchanged.Additional follow up info was received from the treating physician dr.(b)(6), that no significant delay was experienced as a result of this device malfunction, and that it took only 5 minutes to replace the implant with a new one.No patient adverse event in this case.This event is being reported as an mdr in an abundance of caution.Were a similar device (marketed in the us) to experience this malfunction, there is a possibility that it could contribute to a serious injury, necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
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On 25 january 2021, dr.(b)(6) used an illuminoss photodynamic bone stabilization system in a pelvic case.After the timeout of the lightbox, he noticed that the monomer filled implant was not cured.He removed the implant and replaced it with another one.It worked well.Additional follow up info was received from the treating physician dr.(b)(6), that no significant delay was experienced as a result of this device malfunction, and that it took only 5 minutes to replace the implant with a new one.No patient adverse event in this case.The following information was collected and made available to the investigation team: complaint detailed description - initial complaint report - cir-0098 returned product (if available) - product was not returned.Discarded after the procedure.Product evaluation of returned complaint device was not possible photos (if applicable) - no photos were provided radiographs (if applicable) - no radiographs were provided validation testing of the product in question tr-2185 - cure test validation - 9x100 & 9x120mm mini (this report concluded that the 300 second cure time is sufficient to fully cure the liquid monomer.Given that the 9x100 contains a larger quantity of monomer, the 8x100 size would therefore be considered validated for a cure time of 300 seconds as well.) fmea-1002 implants and disposal accessories & fmea - fmea-1004 (light box & accessories) risk review and trend analysis was performed.See below in c.2 (trend review) ifu review: 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.As this procedure was for the treatment of the pelvis in germany, this product was used off label per the indications for use contained in illuminoss ifu 900535 rev.B, which lists the specific bones this device is currently indicated to treat for thie market.Manufacturing dhrs of the product in question - - of the implant with internal light fiber: 400320 / 400260 - of the light box that the light fiber connects to: 100044 review of dhrs: a review of manufacturing records for this lot and components show that the product met manufacturing specifications at the time of product release.The dhrs reviewed were as follows: p/n lot number description 100157-32 400320 boxed, mini sidefire latitude system 8mm x 100mm 200196-32 400260 pouched, mini sidefire latitude system 8mm x 100mm 200198-32 400259 assy, mini sidefire latitude system 8mm x 100mm 300263 380108 timer keys (300 seconds) 200082-100 390063 sidefire plastic fiber 1.0mm assembly 100044 333412 incoming inspection report for blue wave 75vt light box (includes s/n (b)(4)).Root cause analysis tool: the analysis tool used was rule in / rule out: confirmed: rule in rule out out-of spec manufacturing? no: dhrs were reviewed for device, including key subassemblies (e.G.Light fiber).Review of manufacturing records indicate that key assembly steps and components were in specification at the time of manufacture.Specific assembly steps were verified, that must be correct to avoid this complaint's reported failure mode: - light pipe fully tightened in y-connector or cap - y-connector or cap providing adequate grip following insertion of light pipe, preventing light pipe from becoming unseated incorrect timing key? no: timer key dhr reviewed and confirmed that the correct timer key was included with balloon catheter.Broken timer key? no: surgeon indicated that he waited until the light source timed out.No mention that the time required to cure the balloon was 2000 seconds which would have indicated a broken timer key.Even were it to have been broken and defaulted to 2000 per product design, this default time ensures that curing time is sufficient for any size implant, so this would not have been a cause for the observed failure mode.Unvalidated product? no: validation test report tr-2185 confirms 300 second timing period to cure the monomer in a 8x100mm balloon noncompliance with ifu? no: although the procedure (pelvis) is off label use per the ifu, the potential known causes for this failure mode per the fmea are associated with unintentional misuse, not with off-label use (ref: fmea-1002 rev.F) light box not functioning as expected? no: the same light box (s/n 660153u) used during the reported event [the initial implantation of the 8x100mm balloon where the monomer did not cure] was used during the implantation of the second balloon that did cure.This indicates that the light source was working as expected.In addition, a review of the manufacturing inspection records for this light box's serial # indicates that the light box met specification at the time it was released.Unconfirmed: rule in rule out damaged light fiber: this potential cause can not be ruled out nor confirmed, as evaluation of the complaint product was not possible.Possible causes for insufficient curing of the monomer relate to set up and handling issues associated with light fiber management, including: - handling error- kinking the light fiber - handling error - damaged by clamping light fiber or contacting with instrument - handling error - completely fracturing light fiber.Discussion regarding unconfirmed "rule in" causes listed above: although the "rule in/rule out" investigation technique allowed us to rule out many possible causes, and identify that some kind of light fiber malfunction caused this event, the specific cause of that 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.However, the device involved in this complaint was not returned for review and testing, and so the root cause of the light fiber malfunction could not be determined.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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