The reported event can be confirmed based on expiration dates found in dhr reviews and compared with the date of event.During the investigation, it was determined that a hub team member manually changed the expiration dates within webops which allowed for the kit to be shipped with expired product inside.According to previous cases, if the sterile barrier is not damaged prior to the use of orthopedic devices that have expired, the risk of harm is lower.The packaging (i.E., which provides sterile barriers) is typically validated for 7-8 years, so sterility concerns are tempered by this fact.Based on investigation, the root cause was attributed to a distribution-storage related issue.The failure was caused by a hub member performing tasks outside of protocol.A non-conformance investigation was initiated to address the non-compliance of procedures by the hub member.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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