Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records and trackwise databases were reviewed for the provided lot and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Note: the short torque wrench will not fit through the standard antitorque key.Note: the es2 torque wrench or the mantis redux torque wrench may also be used as an alternative to the xia 3 torque wrench to final tighten the xia 3 blockers.The anti-torque key must be used for final tightening.The anti-torque key performs two key functions: allows the torque wrench to align with the tightening axis; helps to maximize the torque needed to lock the implant assembly.Note: the es2 counter torque tube may also be used in conjunction with the xia 3 torque wrench.As the device was not returned, a definite root cause cannot be determined.Based on the description, it appears the blocker may have been misaligned or crossthreaded during final tightening.This could cause difficulties final tightening the blocker, requiring excess torque applied to the blocker, causing the tulip to disengage.
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