This complaint has been reported during a literature review performed by the post market surveillance group.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 pmcf report from (b)(6) medical center, (b)(6).The title of this report is ¿a post- market clinical follow-up (pmcf) of the treatment of tibial shaft fractures with the t2 tibial nail.¿ which is associated with the 'stryker t2 tibial nailing system¿.Within that report, post-operative complications/ adverse events were reported which occurred between 2012 - 2017.It was not possible to ascertain specific device catalog or patient information 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 60 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses pain, delayed healing and revision surgery.The pmcf report states, "the twenty first case reported having pain around the fracture site and was found to have delayed healing.A revision surgery was performed 14 months post op for nonunion.No further complication were noted in this case and the injury consolidated 7 months after the revision operation.".
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