H3, h6: the navio, handpiece, part number 110137, sn: (b)(6), intended for use in treatment was returned for evaluation.The reported problem was visually confirmed.The snap lock nut is detached and the set pin is missing.Although the reported problem was visually confirmed, a functional evaluation could not be performed due to broken/damaged parts.The snap lock nut is broken.No additional functional non-conformances were identified.A review of device records using the nc database, (legacy bbt, caweb4 and smartsolve) confirmed no abnormalities were reported on this device during manufacture.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is mechanical failure of the snaplock nut.Based on the investigation, no further containment or corrective action is recommended or required at this time.
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