Please note the correction to the h6 component code the reported event could not be confirmed.The device inspection revealed the following: the identification of the screw was confirmed based on the catalog # and the lot # marked.The head of the returned screw is heavily worn out on the inside.The wear observed is due to normal implantation and explantation but can also be related to a possible overtightening of the screw on the plate.Small wear could be observed on the screw thread, most probably due to explantation.The discolorization of the head bottom and the damaged thread in the head give indication that the screw was overtightened on the plate.Despite the wear observed, no indication of fragmentation was found.Therefore, the reported event could not be confirmed based on the inspection of this screw.Based on investigation, the root cause was attributed to a user related issue.Evidence of screw overtightening, which should be avoided as it could damage the implant.As a reminder, the instructions for use clearly state that: ¿ screws must not be over-tightened during insertion.Excessive over tightening will compromise the integrity of the screw head, resulting in possible screw breakage." 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 more information is provided, the case will be reassessed.
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