Country of complaint: usa.It was reported by the surgeon, that while drilling, the tip of the burr spun off and burned through a drape.The incident occurred during surgery.Patient x-ray confirmed no drill parts remained in the patient.There was no harm to the patient reported.There was a five (5) minute or less delay in surgery.
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Investigation: the cutter has been analysed visually and microscopically.The diamond cutter at the fore side broke off.Tempering color of erratic appearance can be found at the foreside.Furthermore it can be found directly at the fracture surface.Batch history review: the device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication of a material defect or a manufacturing failure.No further complaints registered against the same lot number.Conclusion and root cause: the failure is most probably usage related.Rational: after the investigation, the tempering color at the cutter indicates that the tool became hot during the operation.Therefore, we assume that an overload situation is combination with insufficient cooling may have led to the breakage due to a thermal stress.No capa is necessary.
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