The reported event could not be confirmed, however the returned device was found to be damaged.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate force during screw insertion.The device inspection revealed the following: the returned plate as well as most of the screws show severe damages / deformations.One screw is still positioned / stuck in the plate hole (spinning though).A close up of this screw shows that the locking thread is indeed badly damaged (unwound), which disables the screw from disengaging from the plate (stuck but still spinning).Similar deformations can be seen on the other screws as well, also most of the screw head interfaces are severely damaged / deformed which clearly indicates that high mechanical force was applied during screw insertion.Therefore the damages were caused during insertion as well as during removal.Note that the bone screw is still intact.Operative technique guide states: "note: when final tightening of the locking screw occurs, take care not to over-torque the screw.Excessive torque may damage the locking mechanism, the screw and/or the screwdriver blade (finger tighten only)." 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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