It was reported that, during a navio-assisted ukr surgery, the anspach bur did not work, they think it is because it did not enter easily through the navio long attachment.It was tested with 2 units of long attachment without success.The procedure was completed with manual instrumentation without significant delay (less than 30 minutes).The patient outcome is unknown.
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H3, h6: the navio long attachment, part number pfsr110006, s/n (b)(6), used for treatment was returned for evaluation.The exterior condition shows minor wear (scratches).A relationship between the reported event and the device was established.The reported problem was visually confirmed.There was a loose bearing inside of the shaft.A functional evaluation could not be completed at the burr was unable to be inserted in to the long attachment.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.The surgical technique guide provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.The most likely cause of this event is a mechanical component failure due to wear and usage over time of the long attachment.This failure is an identified failure mode within the risk assessment.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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