The reported event could not be confirmed, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: not returned.
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As reported: "during the procedure, the drill broke with the k-wire inside.Unable to release k-wire from drill bit.Per surgeon, this event has happened in the past.Upon checking the equipment after, the surgical technologist (st) noticed that the drill looked dull.".
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