The manufacturer became aware of a literature published by the ¿ankle and foot unit, department of orthopaedic surgery, elda university hospital, spain¿.The title of this report is, ¿tibiotalocalcaneal arthrodesis with a retrograde intramedullary nail: a prospective cohort study at a minimum five-year follow-up¿, published on january 14, 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail¿.The article can be found at https://doi.Org/10.1007/s00264-020-04904-3.This report includes an analysis of the clinical data that was collected on 61 patients.The cases in this study range from 2009 and 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced anteroposterior calaneal locking screw back out, which became prominent, requiring revision.The report shows a table that states, ¿in another patient with a t2 nail, the anteroposterior calcaneal locking screw backed out and became prominent, necessitating screw removal, which did not affect the functional outcome¿.
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged anteroposterior calaneal locking screw back out, which became prominent, requiring revision could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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