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.
|
The manufacturer became aware of a literature published by department of trauma, hand, and reconstructive surgery, university of giessen and marburg gmbh in germany.The title of this report is ¿use of the gamma3¿ nail in a teaching hospital for trochanteric fractures: mechanical complications, functional outcomes, and quality of life¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1186/1756-0500-5-651.This report includes research done on 90 patients between the period 1 april 2009 and 30 september 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 haematomas required surgical interventions.The report states: the haematoma was cured in a single step.
|