It was reported that during the surgery, the cannulated endoscopic drill tip unraveled and broke into 2 pieces when reaming inside the patient's joint.Unknown how the surgery was completed and if there was a delay.No other complications reported.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.An analysis of the customer provided image revealed that the outer packaging of the endobutton cl pac-set was shown.The device was not shown.A review of the device 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 a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as pre-cautions and warnings related to the use of the device.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.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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