(b)(4).Report source: (b)(6).Device evaluated by mfr: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 001825034-2021-03023, 0001825034-2021-03024, 0001825034-2021-03026, 0001825034-2021-03027, 0001825034-2021-03028.Not returned.
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(b)(4).Reported event was not confirmed as visual examination of the returned product found no evidence of debris.As the products were determined to be acceptable as no debris was found as reported, a limited investigation process was followed.No product failure was found as the products are within specifications.No further investigation or action is required after review.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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