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 424 military general hospital, thessaloniki in greece.The title of this report is ¿subtrochanteric femoral fractures treated with the long gamma3® nail: a historical control case study versus long trochanteric gamma nail¿ which is associated with the stryker ¿gamma nailing¿ system.The article can be found at http://dx.Doi.Org/10.1016/j.Otsr.2015.06.018.This report includes research done on 158 patients between the period 2000 and 2005.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 (6) cases of perforation of acetabulum (by the threaded guide wire) in the group of the patients treated with ltgn (long trochanteric gamma nail).
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