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.
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The manufacturer became aware of a literature published by taipei veterans general hospital in taiwan.The title of this report is ¿fixation of fifth metacarpal neck fractures: a comparison of medial locking plates with intramedullary k-wires¿ published on december 2, 2019, which is associated with the stryker ¿variax hand plating system ¿.The article can be found at https://doi.Org/10.1177/1753193419896518.This report includes research done on 14 patients in the period between january 2013 and june 2018.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 poor wound healing with fistula formation treated with debridement and antibiotics.The report states: the other case was poor wound healing with fistula formation deep to the plate 2 weeks after operation.We debrided the wound and administered antibiotics for 2 weeks.The plate was not removed.The wound healed, but the fracture healed with a 30° angulation.
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