Investigation summary: the event unit was returned to applied medical for evaluation.Testing confirmed the locking mechanism was functional.Upon further investigation, it was observed that the first four ratchets of the event unit were loose and were able to separate with minimal force.It is likely that ratchet teeth were worn due to normal use over time, which would cause reduced engagement of the locking mechanism.It is likely the event unit had been used multiple times prior to the complainant's experience.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
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