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 department of orthopaedic surgery, gangnam sacred heart hospital, in south korea.The title of this report is ¿gamma 3 u-blade lag screws in patients with trochanteric femur fractures: are rotation control lag screws better than others?¿ published on december 16, 2019, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1186/s13018-019-1427-z.This report includes research done on 185 patients between the period january 2011 and june 2016.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 excessive migration of lag screw.The report states the change in the neck shaft angle was 2.2° ± 5.46.
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