The reported event that twist drill, diam.2.0x102mm, wl 50mm, ao-shaft was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate angulation and too much applied force of the drill bit.The device inspection revealed the following: the visual inspection of the returned twist drill shows deformations of the flutes which indicate that the drill was stuck and got damaged during reverse cycle.The deformed flutes of the smaller part indicates that as well.Note that the shaft is also bent which lead us believe that far too much force had been applied during drilling.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 any further information is provided, the investigation report will be updated.
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