Additional info in: d, g, h results of investigation: the navio bone screw driver pfsr110164, lot 8016483 (united kingdom) used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The driver has separated from the pin driver body.A functional evaluation was not required as the reported problem was confirmed visually.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.As part of our continued process improvement a review of prior escalation actions has determined that this case and associated lot / serial number is related to a corrective/preventive action, nonetheless, no containment has been required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.Further investigation into the reported failure has been conducted, and the potential root cause is a combination of durability issues after extended use (expected wear and tear rate), abnormal use of the tools, or inherent variations in the manual weld process that are present across production lots.The investigation was closed with appropriate risk justification and objective evidence that led to the potential root causes listed above.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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