It was reported that, during an ukr surgery, there was a handpiece failure: the bur did not retract due to broken snap lock nut.The procedure was resumed after swapping out the handpiece.Surgery was delayed, but it is unknown for how long.The patient was not harmed.
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H10: the navio handpiece (part number 110137 / serial number (b)(6)), used in treatment, had a broken snap lock nut during a procedure on (b)(6) 2018.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The snap lock nut was broken.The root cause of this issue was found to be mechanical component failure.As part of corrective actions, a new and more robust design of the snaplock has been released.
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