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 children¿s hospital, nancy university hospital center, 11, allée du morvan, 54500 vandoeuvre-lès-nancy in france.The title of this report is ¿early complications with flexible intramedullary nailing in childhood fracture: 100 cases managed with precurved tip and shaft nails¿ which is associated with the stryker ¿t2 kids¿ system.The article can be found at https://doi.Org/10.1016/j.Otsr.2011.11.011.This report includes research done on 97 patients between the period january 2009 and december 2010.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 skin lesions in tibial fracture for which early nail re-cutting was performed.
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