This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h6, h10.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Visual examination of the returned product identified the handle is cracked and the device shows wear and tear from repeated use.The plunger assembly was not returned with the device.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The reported event has been confirmed through product return.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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