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 hospital of southern denmark, in denmark.The title of this report is ¿failure of short versus long cephalomedullary nail after intertrochanteric fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jor.2019.10.018.Within that publication which included 216 patients, post-operative complications were reported, which allegedly occurred from 1st january 2012 to 31st december 2012.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 (3) cases of cut out (long nail) for which reoperation was performed.
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