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On 09feb24, sales representative reported a broken dynanail 10mm x 300mm nail that required revision removal surgery on (b)(6) 2024.(b)(6) stated the implant was installed in the patient "roughly 1 year and 2 months ago by dr at (b)(6).The reason for revision was nonunion of the tibiotalar joint.At the place of nonunion the nail broke in half, including the internal nitinol element.Dr believed this to be caused by his original nail placement being too far medial in the calcaneus.The broken nail was removed and replaced with a 12x300mm dynanail xl." the broken nail component will not returned as it was discarded by the facility.Remaining specifics of staple implant, case information, patient notes, operative notes, and information to determine conclusive cause is unknown but will be determined in this complaint investigation.The device failure, which resulted in patient pain and removal, fits the category requiring a 30-day mdr to report per qs-8.2.1.3, sop, medical device reporting.As the initial report indicates that the cause may be related to surgeon technique / nail implantation, there is no suggestion that field action / removal is necessary at this time.A supplemental mdr report will be filed for complaint (b)(4) when all necessary information has been obtained and the complaint investigation has been completed to determine root cause and potential actions / corrective actions.
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On 09feb24, sales representative reported a broken dynanail 10mm x 300mm nail that required revision removal surgery on (b)(6) 2024.Ryan shields stated the implant was installed in the patient "roughly 1 year and 2 months ago by dr (b)(6).The reason for revision was nonunion of the tibiotalar joint.At the place of nonunion the nail broke in half, including the internal nitinol element.Dr believed this to be caused by his original nail placement being too far medial in the calcaneus.The broken nail was removed and replaced with a 12x300mm dynanail xl." the broken nail component will not returned as it was discarded by the facility.Remaining specifics of staple implant, case information, patient notes, operative notes, and information to determine conclusive cause is unknown but will be determined in this complaint investigation.The device failure, which resulted in patient pain and removal, fits the category requiring a 30-day mdr to report per qs-8.2.1.3, sop, medical device reporting.As the initial report indicates that the cause may be related to surgeon technique/nail implantation, there is no suggestion that field action/removal is necessary at this time.In conclusion, based on the reported information provided from the surgeon and review with clinical affairs, the most probable root cause is as follows: non-optimal compression combined with potential off-axis loading as nail was implanted at slight angle towards medial side of patient.Subsequently, as the subtalar joint did not fully fuse as desired, patient physical activity after the fact likely resulted in the nail functioning in a "static" manner and breaking due to repeated stress loading.The photos in figures 1 - 3 do not show anything concerning regarding the fracture which would suggest a defect in the nail or material.Without union of the subtalar joint, a high mechanical demand is placed on the hardware, and such a failure is not unexpected in this suspected fatigue loading scenario.Generally with a nonunion, this is the fracture pattern/location that should be expected, as it occurred at a location near where the nail diameter transitioned from a larger to smaller size.Of the 3 potential causes listed in ed-50048 risk matrix, dhr review does not suggest "material failure" to be the cause.Therefore, based on info provided likely combination of "non-union of bone" followed by approximately 6 months - 1 year of "excessive forces placed on nail".Further, mk-10062 "warnings" section states: "the dynanail ttc fusion nail is intended to facilitate healing but is not designed to support the patient's body weight in the presence of a delayed union or nonunion of bone.Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing.Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established.Failure to immobilize the ankle during healing may result in bending and/or breakage of the device and/or failed fusion." despite the breakage of the nail, which required full removal, the surgeon indicated that "he loves the product" (in email from 07mar24) and does not see a deficiency in the nail, system, or manufacturing, as demonstrated by multiple years of previous successful dynanail surgeries.Complaint history review shows 3 dynanail nails that have had this failure in the last year, which represents a (b)(4) failure rate (3 failures/5,000 dynanail surgeries in last year).Given the cause determination, extremely low rate of occurrence of this failure mode, successful revision surgery and no indication of manufacturing/material deficiency, no corrective action will be taken at this time.Future similar complaints shall be monitored per qs-8.2.1.1, sop, complaints and further actions may be taken if necessary.
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