(b)(4).Report source: source: (b)(6).Multiple reports were submitted along with this report 0001825034-2021-01794, 0001825034-2021-01795, 0001825034-2021-01797, 0001825034-2021-01798, 0001825034-2021-01799.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.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, h1, h2, h3, h4, h6, h10 visual evaluation of the returned products identified that the outer sterile cavities have been damaged.Sterility has not been compromised on any of the products complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no related deviations or anomalies during manufacturing.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage.A corrective action has been previously raised to implement improved packaging changes that were determined.These packaging changes will reduce the number of transit-related packaging damage events.A corrective action was raised to assess the risk.It was determined that no further corrective actions are necessary at this time.Upon investigation, it has been determined that the product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided 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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