This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, h10 visual examination of the returned product identified one of the product's plastic sleeve has fractured and not all the pieces were returned.The other product has a bent tip.A function test of the plastic sleeves was not performed due to the product damages.Lot cannot be confirmed as it's not etched on the device.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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