On the literature article named "tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients", it was reported that, after cannulated screws screw had been implanted on 1 patient, after conventional internal fixation surgery using three 7.3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, one patient had a screw which began slipping and migrating from its original position.This was noticed 3 months postoperatively.12 months postoperatively, the femoral head was displaced again.Further details on how was this adverse event treated are unknown.
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H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, per the complaint details, no further information is available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be rendered nor can we determine a definitive clinical root cause of the reported failure.The physicians referenced in the abstract provided an analysis of all the attached images within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant patient-specific documentation be provided, this complaint would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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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