It was reported that on literature review, "triple endobutton technique for repair of chronic complete acromioclavicular joint dislocations." a case of loss of reduction and joint subluxation was reported 1 week post-op after having used an endobutton.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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.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 complaint history review concluded this was a repeat issue.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A clinical investigation found that without supporting clinical/medical documents, a thorough investigation cannot be performed.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 clinical information be provided this complaint will be re-evaluated.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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