(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, the unit had a locking issue with the lid opening during use.No repair has been performed due to rejected quotation from the customer.Device has been recycled in zimmer geneva premises as per customer instruction.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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