Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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It was reported after the final tightening with non-ratchet, t-handle, it was not possible to remove the counter torque tube.The surgeon had to use another instrument to remove it.The strength used for the removal of it caused 2 screws that were implanted during the surgery to come out.The surgeon had to implant 2 new screws to replace the 2 screws that were accidentally removed.The surgery was completed.No further patient impact was reported.
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