The reported event that long nail kit r2.0, ti, left gamma3® ø11x420mm x 125° was alleged broken could be confirmed, since the device was returned for evaluation.The device was returned for inspection and was found to be broken.The appearance of the fractured surfaces indicated the nail had broken in fatigue manner contributed by significant tensile and torsional stresses.General aspects: the gamma nail is a temporary implant.Loads on the device produced by load bearing and the patient's activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
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