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 study from general hospital of (b)(6).The title of this report is ¿treatment of humeral shaft fractures with antegrade intramedullary locking nail¿ which is associated with the stryker ¿t2 locking nail¿ system.Within that publication, post-operative complications/ adverse events were reported, which published on 05 april 2011.It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 6 complaints was initiated retrospectively for adverse events mentioned in the report and the pubmed id for the literature is 21744026.This product inquiry addresses fracture at the distal end of the nail.The report states: ¿there was a fracture at the distal end of the nail after the patient fell down the stairs 6 weeks following the index procedure, and the fracture was treated conservatively using a functional brace.¿.
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