The reported event that sonicanchor kit 2.5x10 mm / force fibre #0 / c-2 was alleged of 'sterile period expired' could be confirmed.Based on investigation, the root cause was attributed to be user related, since it is the responsibility of the medical staff to check the sterility dates of the products that are used on the operative room.As a reminder, the ifu states: ¿ inspection is recommended prior to surgery to determine if implants have been damaged during storage or prior procedures.Ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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