The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Visual inspection of the returned devices was performed and following observations were made: the right gamma3® ø11x360mm x 125° nail was found to be broken (fatigue fracture) at its proximal nail hole.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.According to available information a long gamma3 nail had broken after an implantation period of approx.7 months.General aspects: 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.Furthermore the patient¿s height (170 cm) and weight (110 kg) indicate obesity (38.1 bmi).Most likely the nail broke in a fatigue fracture due to patient conditions.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instruction for use was reviewed: ¿3 contraindications obesity.An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself.¿ if any further information is provided, the investigation report will be reassessed.
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