It was reported that, during set up for a navio assisted surgery, it was noticed that the navio handpiece would not home.There was no movement.Handpiece test attempted through admin and tests failed.There was no movement noticed with snap lock.The procedure was finished with a smith and nephew back up device without delay.As this was noticed before the case, the patient was not involved.
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H3, h6: the navio handpiece, part number pfsr110137, sn (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The evaluation failed, the gear would not turn by hand and the system could not communicate with the handpiece.No additional functional non-conformances were identified.The most likely cause of this event is mechanical failure related to the motor.A review of manufacturing and 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.The review determined that prior escalation actions are applicable to the scope of this complaint, however, no further escalation action is required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.As a part of corrective action a design change to help reduce build up within the motor.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.
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