The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a post market clinical follow-up report received from university of kansas hospital, in usa.The title of this report is ¿a retrospective data collection of the treatment of the ankle with the t2 ankle arthrodesis nailing system¿ which is associated with the stryker ¿t2 ankle arthrodesis nailing¿ system.This report includes research done on 127 patients between the period april, 2019 and january, 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses nonunion followed by backing out of talar screw.The report states: ¿(b)(6) year old male with past medical history of tobacco use and obesity underwent ttc for nonunited subtalar fusion and tibiotalar arthritis.Patient was diagnosed with nonunion at 473 days postoperatively.This was not felt to be device related as patient had preexisting nonunion with a separate device used.Patient noted to have backing out of talar screw at 592 days.Patient never had a revision procedure.This is ongoing.¿.
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