This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report/final report based on information discovered during the device evaluation.Review of the most recent repair record determined the unit operated as intended and was within calibration; however, it was determined the width plate had failed and was replaced.Review of the device history record identified no deviations or anomalies during manufacturing.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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