The reported event could not be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed "fracture is not visible in the x-ray, but that is after plating was performed and there is only very little bone substance visible at the base of the malleolus.If i can guess, the poor bone substance is the underlying cause of the fracture, but the fracture itself was likely caused during preparation of the bone for the implant/during the implantation.But this cannot be confirmed.This cannot be assessed any further." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.According to the medical expert assessment there is no fracture visible in the x-ray, the poor bone quality as well as the preparation of bone during the implantation could have contributed to the cause of the fracture, but it cannot be confirmed with the given information.If device is returned or any further information is provided, the investigation report will be reassessed.
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