This complaint has been reported during a literature review performed by the post market surveillance group.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 study from (b)(6) university hospital, (b)(6) which was published in november 2017.The title of this report is ¿interest of navigation for the treatment of pertrochanteric fractures with the gamma 3 nail¿ which is associated with the stryker gamma 3 nailing system.Within that publication, postoperative complications/ adverse events were reported which occurred from may 2015 to april 2016.It was not possible to ascertain specific device catalog or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 2 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses cut-out.1 out of 2 cases.
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