All available information was investigated, and the reported detached actuator knob was confirmed via returned device analysis.Additionally, the release crimper was observed to be scratched.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and the returned device analysis, the cause of the observed scratched release crimper was unable to be determined.The investigation determined the reported detached actuator knob to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
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