In a scientific publication, zelle, "safety and efficacy of a two-screw cephalomedullary nail for intertrochanteric femur fracture fixation: a retrospective case series in 264 patients" it was reported that the patient underwent a revision surgery due to symptomatic hardware.
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It was reported from a literature study that the patient underwent a revision surgery due to symptomatic hardware.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The principal goal of the study was to examine the mechanical failure rates and to determine the safety and efficacy of this cephalomedullary nailing system.The results of the retrospective study confirmed the hypothesis that the innovative two-screw cephalomedullary nail is a safe and reliable nailing system for the treatment of patients with intertrochanteric femoral fractures, the nail system had a low cut out and mechanical failure rate.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to pain, infection or patient allergy.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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