H3, h6: the navio drill part number 101209, s/n (b)(6), used for treatment was returned for evaluation.There was a relationship between the device and the reported event.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.Visual inspection of the device revealed that exterior showed minor wear.No other visual discrepancies were observed.A functional evaluation was performed and revealed that the reported problem was confirmed as the drill was overheating after 60 seconds, and the drill was audibly louder than expected.The root cause was determined to be 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.
|