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 literature published by royal cornwall hospital, in uk.The title of this report is ¿arthroscopic subtalar arthrodesis through the sinus tarsi portal approach: a series of 77 cases¿ which is associated with the stryker ¿asnis iii¿ system.The article can be found at http://dx.Doi.Org/10.1016/j.Fas.2017.04.006.Within that publication which included 74 patients, post-operative complications were reported, which allegedly occurred from april 2004 to february 2014.It was not possible to ascertain specific device details or patient information 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 ipsilateral below knee deep vein thrombosis requiring anticoagulation.
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