H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states per the complaint details, a study patient (sited from a literature review) ¿1 patient had a deep vein thrombosis¿ after a fascial incision and adhesiolysis combined with radiofrequency microtenotomy procedure.¿ smith and nephew has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.Therefore, the root cause of the reported deep vein thrombosis and/or the patient outcome beyond that which was documented in the aged article cannot be confirmed nor concluded.No further medical assessment is warranted at this time.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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