It was reported that, during navio lab/demo, the drill and long attachment fused into snap lock, every time the long attachment seats into the snap lock it will not release even without any burring.It was tested on another handpiece and was fine.
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The navio handpiece, part number pfsr110137, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The hp passed handpiece testing and calibration/homing with no incident.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 has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of seating drill into handpiece.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
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