The device history record was checked and conformed to specifications, including device hardness.The returned device was inspected and found to have fractured at the weakest spot, the thread run-out.Dimensions were verified and conform to specifications.The microstructure of the drill is homogenous and shows no anomalies.The drill core was measured at the fracture point and found to conform to specifications.The fracture surface reveals that the drill was strongly bent, as can occur when a drill is positioned obliquely or subject to excessive torsion force during use.Bone residue was found in the thread run-out area, indicating that the drill did not fracture immediately as stated.Additional information has been requested regarding the handpiece and the rotational speed used during the operation.[(b)(4)].
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In accordance with the surgeon's report, during plastic surgery he attempted to use a twist drill, but the device broke immediately.It was replaced by an identical drill bit from the same lot, which also broke immediately.The fractured tip of the second drill was deflected by the bone and flew at the surgeon's face, barely missing his eye.No patient harm.This report is for device #1 of 2 used during the same procedure.
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