The device was returned for evaluation.The exterior condition shows minor wear (scratches).Nothing was identified visually that contributed to the reported problem.Functional evaluation was performed.The pin driver was attached to a bone pin and an attempt was made to turn/rotate the bone pin.The pin driver failed to turn/rotate the bone pin because the inner driver is no longer attached to the pin driver.A review of manufacturing records found no related non-conformances or anomalies associated with this device during production.Therefore the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the pin driver and failure mode(s) identified similar events.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.Navio user manual 500197 rev b indicates "using the bone pin driver and a surgical drill: 5.Drill the first bone pin through the tissue protector, perpendicular to the surface of the bone, taking care to only engage, and not perforate, the opposing cortex." drilling perpendicular is recommended when using the pin driver.No further containment or corrective actions are recommended at this time.
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