Correction: refer to d4 lot number the reported event could be confirmed, since the image of the broken drill was provided and matches the alleged failure mode.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 communicated was not correct due to which the corresponding file could not be traced in the records.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿in the rare event of twist drill failure, drill guides serve to protect the user, patient, and other third parties.When testing twist drills in free air prior to surgical use, it is recommended to use the lowest possible rotational speed.This enables the user to more easily assess concentricity and proper direction of rotation.¿ 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.However, in general few of the probable causes of twist drill breakage are wrong speed for drilling, no axial guidance (torsional bending breakage) etc.If the device is returned or any further information is provided, the investigation report will be reassessed.
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