This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged extensor synovitis, requiring material ablation, 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.Device not available.
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The manufacturer became aware of a literature published by the ¿university of medicine and pharmacy carol davila bucharest, st.Pentelimon emergency hospital, romania.¿the title of this report is ¿association of kirschner wires and shape-memory staple in four-corner arthrodesis ¿, published on march 01, 2019, which is associated with the stryker ¿easyclip¿ system.This report includes analysis of the clinical data that was collected on 12 patients, and the cases in this study range from 2012 and 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 1 patient experienced extensor synovitis caused by wire conflict with extensor tendons, requiring material ablation.The report states,¿ in one patient we found extensor synovitis, caused by wire conflict with extensor tendons and pain in the medial side (staple).¿.
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