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 orthopedic surgery and trauma department, (b)(6) hospital in (b)(6).The title of this report is ¿minimally invasive osteosynthesis in stable trochanteric fractures: a comparative study between gotfried percutaneous compression plate and gamma 3 intramedullary nail¿ published on august 12, 2009, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at doi 10.1007/s00402-009-0955-0.This report includes research done on 40 patients between the period june 2006 and march 2007.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 (2) cases of cut-out.
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