Correction: refer to d4-lot #.The reported event could be confirmed.The device inspection revealed the following: the visual inspection showed that the screw is severely damaged.The screw's head shows traces of wear (small deformation), a sign that large forces were applied while inserting the screw.Therefore, this case is classified as a user related issue.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by the mishandling of the device (large forced applied on the part).If any further information is provided, the investigation report will be updated.
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