Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained as the device remains implanted in the patient.It was reported that at the time of final tightening, the fastening force weakened before the appropriate torque of 12nm was reached as the serrato surgical technique states.A root cause cannot be determined.Possible causes include cross threading/misalignment of the blocker, rod not fully reduced before final tightening, excessive force applied, overtightening, anti torque not used, and/or torque wrench not fully inserted into blocker.
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