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.
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The manufacturer became aware of a literature published by (b)(6).The title of this report is ¿causes and treatments of lag screw¿s cut out after intramedullary nailing osteosynthesis for trochanteric fractures¿ which is associated with the stryker ¿gamma3¿ nailing system.The article can be found at https://www.Mattioli1885journals.Com/index.Php/actabiomedica/article/view/2912.Within that publication which included 20 patients, post-operative complications were reported, which allegedly occurred from september 2004 to november 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 cut out of lag screw and nail breakage which were treated by reosteosynthesis.The report states: ¿the patient revalued, who had been subjected to reosteosynthesis of the nail and lag screw + metallic cerclage, was a young (b)(6) years old man with a subtrochanteric fracture a3.The failure of the synthesis was mechanical: malproduction of the fracture and implant breakage 2 months post-operatively¿.
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