(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h4, h6, h10.Dhr review was performed.Device was 17 months old and is not out of box failure.Upon receipt, there was a locking issue with the lid.Sent back to customer unrepaired as requested.Device is used for treatment a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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