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 st.John hospital and medical center, in usa.The title of this report is ¿smart toe® implant versus buried kirschner wire for proximal interphalangeal joint arthrodesis: a comparative study¿ which is associated with the stryker ¿smart toe¿ system.The article can be found at https://doi.Org/10.1053/j.Jfas.2013.02.007.Within that publication which included 58 patients, post-operative complications were reported, which allegedly occurred from 1 january 2007 to 31 december 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 (3) cases of implant fracture which needed revision surgery.The report states: ¿fracture of internal fixation occurred in 12 (20.7%) of the smart toe implants and 2 (7.1%) of the buried k-wires.Of the 12 fractured smart toe implants, 7 (58.3%) were 16-mm straight, 3 (25%) were 16-mm angulated, 2 (16.7%) were 19-mm straight, and 0 were 19-mm angulated.Revision surgery was needed in 5 (8.6%) of the smart toe and 3 (10.7%) of the buried intramedullary k-wire implants.¿.
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