Correction: please refer to d4 lot number.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the anterior web suggests that the nail breakage had its origin in this area.Severe drill marks were found at the entrance of the proximal hole.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect).The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest/ waves in both the anterior and posterior web.Starting from the anterior web with an incipient crack at the lateral edge, the breakage progressed through the cross section.Gradually, alongside the anterior web, the posterior web also started getting fatigued and broke ultimately.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by user, as the presence of drill marks on the nail indicates towards a user induced cause of failure.The fracture pattern indicates fatigue due to stress evident by line of rest/ waves, the root cause is determined to be user related, predominantly.If any further information is provided, the complaint report will be updated.
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