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 outer surface of the nail handle shows no sign of damage or misuse.A closer observation of the circumference of the inside thread where the nail holding screw locks shows fretting marks which is due to improper use of the device.Further, both pegs show deformed surfaces may be due to repetitive and long use.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 the above investigation and provided information, the root cause was attributed to a user-related issue.The failure was caused by the handling failure during assembling and dissembling which led the holder to damage and eventually impaired assembly with the holding screw.If any further information is provided, the complaint report will be updated.
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