It was reported that during the drill diagnostic test of a cori assisted tka procedure, the real intelligence robotic drill failed the homing torque test.When swapping the handpiece to a new one, the device got jammed with the drill tracking array and the long attachment.There was a delay of fewer than 30 minutes due to this event and procedure concluded with manual technique.The patient was not harmed due to the described event.
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Additional information: d4.H3, h6: the cori drill, pn (b)(6), (b)(6) , intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.The drill was tested using a tester long attachment.The drill passed kpc test and a case was review successfully without any resistance removing the tester long attachment.The drill was found to operated as design.Although the reported problem was not confirmed, factor that may have contributed to the reported symptom may have been associated with an intermittent failure of the exposure motor.Refer to cori user manual appendix d: recovery procedure guidelines for guidelines for recovering to a fully manual procedure.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.
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