It was reported that, during a navio tka procedure, the anspach drill smelled like it was burning and was making an unfamiliar noise, even not during the actual burring phase.The drill then failed the drill test with an abnormal homing torque.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
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H3, h6: the product, navio drill, part number 101209, s/n (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The device would not activate, as the device's motor was burnt out.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.The most likely cause of this event is mechanical component failure of the motor shaft.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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