It was reported that during a cuff repair the anchor broke when inserting, all pieces removed.The procedure was completed with a backup device and no delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: 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.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 print specifications found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.
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