Visual inspection: it was observed that the tabs on the inner collet had fractured.Deformation was observed on the outer and inner collet as well.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was communicated by the initial reporter that a mesa rod unlocker, instead of a mesa rail unlocker, was used.It is likely that the use of a mesa rod unlocker on a rail created misalignment on the screw head and excess loading during unlocking, resulting in the observed tab fracture.The cause of the reported issue will be classified as 'deviation from surgical technique'.
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