Evaluation summary: the reported event that smart toe ii 19mm / 10° angle (implant) had no expansion during surgery could not be confirmed since the returned device is conforming to specification.Therefore, the case could be classified as a non-issue.Based on investigation, the root cause of the determined problem of expansion was attributed to a user related issue.The smart toe ii 19mm / 10° angle (implant) expansion problem was caused by mismanagment of the temperature.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.If any further information is provided, the investigation report will be updated.
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