The reported event that 2.3x26mm locking screws, cross-pin, self-t was alleged of 'known misuse reported by the user' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related: this is the operative room staff responsibility to check sterility and integrity of the device before implanting it.In addition, devices were sent to customer when they were out of date of usage; sterility was not ensure.The distribution site has been contacted and a nc will be opened to address this situation and to avoid any new occurrence in the future.However, it remains hospital responsibility to check that all available material is conformed before the surgery.The instruction for use (v15013 rev n non active implant ifu) reads: ''for detailed information concerning the identification of the product (such as system association, catalogue no.(ref), material, expiration date of sterile products) please refer to the marking on the product and/or the labeling of the package.¿ [original statement] therefore this case is classified as user related.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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