It was reported that, during an unspecified surgery, the black stopper on inside of the handpiece is broken and did not stay attached: it was spun so it could temporarily lock into the metal, allowing to properly calibrate the handpiece and continue with the case.Surgery was not delayed.The patient was not harmed.
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The navio handpiece (part number 110137 / serial number (b)(6)), intended for use in treatment, had a broken snap lock nut prior to 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 and detached from the rest of the snap lock.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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