It was reported that the patient received heat burns on their cheek.The twist drill was being used at 30,000 rpm with a trocar.It is stated in ifu 90-274-92-40 and 91-600-00-41 under precautions "when using twist drills, copious amounts of irrigation are mandatory to alleviate excessive heat generation, which can lead to bone necrosis, and in extreme cases, soft tissue burns through contact with trocar and cannula." and "twist drills are not designed to be used at speeds in excess of 5000 rpm.".
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An investigation was performed in the lab.The review of the device revealed no breakage and only surface damage.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.The investigation results conclude that the most likely root cause was due to an increased speed [rpm] of the drill.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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