(b)(4).Concomitant medical products: 115370, comprehensive reverse tray co 44mm, 638530, 110017268, humeral bearing assembly tool, 12783-01.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 11250.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product confirms that the ringloc is stuck in the humeral tray and damaged where it shows through the extraction slot.There is some damage to the bottom of the inserter tool exactly where it would contact the ring.The bearing shows some signs of damage exactly where the ringloc is stuck in the tray.The tray is visually conforming to the print.The locking ring was found to be dimensionally conforming.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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