The reported event that t2 proximal humeral nail - short nail- 240 mm was alleged of issue implant revision / removal without implant breakage could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.This complaint has been reported during a literature review performed by the post-market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.The device inspection was not possible as the product was not returned for investigation.Based on the investigation, no definitive relation could be established between the product and the reported adverse consequence.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device disposition unknown.
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The manufacturer became aware of a 'retrospective data collection report' from (b)(6).The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn).Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017.It was not possible to ascertain specific device catalogs 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, 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses non-union (no bone consolidation within 6 months).1 out of 2 cases.The report states, "a (b)(6) caucasian male (#71) presented with functional deficit more than 1.5 years after diaphyseal humerus fracture treated with t2 phn.Dislocated fragments without bone consolidation were diagnosed radiologically.Follow-up was not reported.".
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