It was reported that during femur burring in a navio tka procedure, they got an error.They unplugged the anspach drill and plugged it back in but, then, they got an error.They allowed the drill to cool and when they tried to burr, they got an error again.They were unable to clear the error; so, they opened a new tray and completed the case with the new drill.A delay of fewer than 30 minutes was reported.No patient injury or other complications were reported.
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The navio drill, part number 101209, s/n (b)(6), used in treatment was returned for evaluation.A relationship between the reported event and the device was established.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A functional evaluation was performed.The reported problem was confirmed.The device would not activate.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 electrical component failure.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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