Literature case.It was reported that a synovectomy and a thermal shrinkage on the left thumb was performed by using a shaver to treat mcpj volar plate instability.However, this case had recurrence of thumb mcpj hyperextension noted at 10 weeks post operation which progressed to 30 degrees of hyperextension at 6 months post op.The patient complained of persistent pain and weakness at the thumb.Therefore, open volar plate capsulodesis with suture anchor was performed at 13 months after the first operation.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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.No product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and instructions for use review could not be conducted.Without supporting clinical/medical documents, a thorough clinical/medical investigation cannot be performed.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 evaluation will be re-opened for investigation.
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