It was reported that, upon calibration in a cori assisted tka surgery, a real intelligence robotic drill failed to unlock to accept the bur.No sound was made by the drill after the unlock button was pressed on the screen and a critical error was received immediately followed by an internal error.The drill was swapped and the case was successfully completed without delay.As this happened before surgery, there was no patient involvement.
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Additional information: d8, h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the real intelligence robotic drill, part number rob10013, sn(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 burr was able to be loaded and locked during a kpc test and a case.A calibration, case, and kpc test were all completed without error.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may have been associated with a bad drill attachment retaining nut or an intermittent exposure motor.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 found similar 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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