The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the nail is received in an assembled condition, and no visual damage was observed over the nail surface.Since, all the 3 devices were stuck together, a functional inspection was not possible.The received devices were not possible to disassemble, therefore a definitive root cause could not be determined.The alleged event is most likely caused due to an oblique insertion/cross threading/some debris inside the hole.The investigation of the parts involved indicates that it is likely that the observed issue of seizing of the nail holding screw is possible, if an unfavorable constellation of several dimensions (extreme value and specific direction) meet when assembling the devices.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.If any further information is provided, the investigation report will be reassessed.
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