H6: the navio bone pin, p/n pfsd01008, lot tu60072-01, intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported issue was visually confirmed.The bone pin is bent approximated to a 45 degree angle in the the start of the threads.A review of manufacturing 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 was external forces and/or pressure apply to the pin.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to the navio surgical system user¿s manual for proper handling.Components break / wear or spinning bur contacts inside of guard causing flaking / material dust.Per complaint, the component is a demo one thus no patient harm or injury was report.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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