It was reported that during a tka procedure, the attempting to make the initial distal cut, the e2 error appeared.The anspach drill was swapped out, but it also resulted in an e2 error.The procedure was changed to manual technique with a delay of less than 30 minutes.After the case, when the drills were tested, both successfully passed the drill test.The issue seemed to be a system error.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 (npfs02000) device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation 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 found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) provides information for anspach console usage and troubleshooting in the "preparing the anspach drill console" and "common problems & solutions table" sections.A relationship, if any, between the subject device and the reported event could be determined.Based on the information and troubleshooting notes provided in the complaint that the e2 error was present with multiple drills, and was cleared with a reboot.This was an instance of the randomly occurring e2 error that can be only cleared by system reboots.A corrective action has been opened for this issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.The medical investigation found that per complaint details, an e2 error appeared during the initial distal cut of a tka procedure and persisted after the anspach drill was swapped out.Reportedly, the navio was abandoned and the procedure was completed using a manual technique with a 0-30 minute surgical extension.Requested medical documentation was not provided.Of note, it was reported that after the case the navio was rebooted and both drills successfully passed the drill test.Based on the information provided, there was no patient injury reported due to the 0-30 minute surgical delay or the modified surgical technique, as the procedure was completed manually.No further medical assessment is warranted at this time.
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