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 orthopaedic and traumatology department, s.Andrea hospital in italy.The title of this report is ¿intertrochanteric fractures: comparison between two different locking nails¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at 10.1007/s00264-012-1684-5.This report includes research done on 110 patients between the periods from january 2006 to january 2008.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 7 cases of malalignments.The report states six valgus and one varus were observed.
|