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 the star recess tip is broken off as reported, the broken off part did not get returned for evaluation.The screw driver is in a well-used condition, with marks of scratches and discoloration around the screw driver, especially on the shaft there is a scratch mark which is most likely from contact to another part.The tip section is showing that the star recess tip got twisted by tightening, before it sheared off, also there a stress marks from high applied mechanical force visible, visible as hairline cracks.All dimensional and material integrity inspections which have been taken are within accuracy.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 a use related issue.The failure was caused most likely by to much force.If more information is provided, the case will be reassessed.
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