This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d4, d9, g2, g3, g6, h2, h3, h4, h6, h10.Functional testing of the device determined that the device did pass the rpm test.The control bar was not flush with the master blade and calibration was not in limits when set to the 0 reading.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed.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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