Stryker became aware of the publication ¿inadequate ¿three-point¿ proximal fixation predicts failure of the gamma nail¿, published in the bone & joint journal which was published in june 2013 and is associated with gamma3 long and trochanteric nails.Within that publication 25 post-operative complications/ adverse events were reported, which occurred between 2006 and 2010.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database however revealed that the events had not been reported by the hospital or by the author of the publication, therefore 25 complaints were initiated retrospectively.This product inquiry addresses a fixation failure: loss of fracture reduction with migration of the lag screw within the proximal fragment after 27 weeks of implantation of an unknown gamma3 long nail.Event 6 of 12.
|