Internal complaint reference: case (b)(4).H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A review of the customer provided image reveals a black residue in the patients knee.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended force and side loading of the device, leading to premature wear.No containment or corrective actions are recommended at this time.
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