The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual inspection: visual examination of the received product shows that screw received has an intact tip and shaft thread, but the screw head is in a badly damaged and deformed condition.The hex is completely worn from too much force and the ring from the top head end of the screw is deformed, furthermore the wall between the head diameter and the worn hex got burst.The damage at the screw head is most likely the result from removal with pliers.Dimensional inspection: outer diameter of the shaft thread, diameter 3.50mm +0/-0.15 = result 3.42mm and outer screw head diameter, diameter 3.50mm +0/-0.15 = result 3.46mm.Tested with calipper no.4525 , the measure results are within accuracy.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely by to much force.If any additional information is provided, the investigation will be reassessed.
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