It was reported that, during a cori-assisted ukr surgery, and when setting up the robotic drill in the robotic drill diagnostic screen and after pressing ¿unlock¿ to insert the bur, the drill did not allow the tech to fully seat the bur through the long attachment (case-(b)(4) and case-(b)(4)).Normally the tech is able to feel two clicks after inserting the bur before pressing ¿lock¿.These steps were performed multiple times before deciding to enter the case and unlock the bur from the case.After pressing ¿unlock¿ the system prompted with a system fault error message stating there was a communication failure and to call robotic support.The robotic drill was disconnected, reinserted and the error continued to occur.A full reboot of the system was conducted and the error still prompted (case-(b)(4)).The procedure was finished with smith and nephew back up devices after a significant delay (more than 30 minutes).The patient was not harmed.
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H3, h6: the cori drill attachment, p/n rob10015, (b)(6), used in treatment was returned.A relationship between the reported event and the device was established.Nothing visually contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The drill attachment shaft is obstructed.The bearing nut was loosened and it was found that the top bearing broke down and failed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is mechanical component failure of the bearings.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
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