It was reported that, during set up for a navio assisted tka surgery, they went to calibrate the anspach emax 2 plus hand piece - rohs and the gears jammed and they kept receiving the handpiece motor control failure error.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.
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H3, h6: the anspach emax 2 plus handpiece (us), pfsr101209, sn (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with a mechanical component failure.A capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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