The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per subsequent email, no relevant clinical information will be provided for inclusion in this investigation.Therefore, a thorough medical investigation of the reported pseudarthrosis, the fracture or the reported revision cannot be rendered.According to the surgeon, ¿the s&n devices were not defective.¿ per communications, the outcome of the patient is unknown and no additional information is available at this time.Should additional medical information be provided, this complaint will be re-asssessed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, abnormal loading of the limb or excessive forces applied to the implant.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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