This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual analysis confirms that the tip of the driver is twisted and fractured.The dhr review noted no discrepancies and indicated the device was conforming to specifications.Review of the complaint history determined that no further action is required.The root cause of this failure is related to plastic deformation as a result of the design of the device.These drivers have been designed to twist before fracture of the screw.The driver can still fracture, if torque continues to be applied, but this happens only after the driver first twists.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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