Correction: cat#, lot# the reported event that locking screw anchorage ø3.0mm / l20mm was alleged of 'poor fixation' could be confirmed.The root cause of this positioning issue has been identified as user related.When too much torque is applied during screw insertion, it can happen that the screw goes through the plate.Please note that operative technique an-st-1 en rev 2 anchorage op tech reads: all threaded holes can accommodate either locking or non locking screws (3.0mm and 3.5mm diameter).The compression ramp only accepts 3.0mm non locking screws.Applying excessive torque during screw insertion is not recommended, and may result in damage to the screw head.In particular for non locking screws it is recommended to tighten the screw head until contact with the plate, then release from tightening.However, it was identified that under certain circumstances, the screw might slip through the plates.This might lead to prolongation of surgery time (less than 15 minutes) and in rare cases a bone damage due to an unused screw hole can occur.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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