Correction: please refer to h6 device & component code.The reported event could not be confirmed, since the returned device is found to be fully functional and conforming to specifications.The device inspection revealed the following: the received set screw shows significant threads deformation.The threads appear to splayed and flat.The nylon stopper also shows thread marks & slight degradation which indicates the set screw was able to be inserted to some depth.Sight metal debris is also found to be stuck all over the screw threads.All of this indicates that the set screw was most likely misaligned during insertion, hence damaging the threads.A functional test was performed to check the functionality of the received set screws and the nail.Upon testing it was observed that both the set screw could easily be inserted and removed from the nail.Thus, the reported issue could not be reproduced, hence could not be confirmed.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 investigation the root cause was attributed to a user related issue.The received set screws and the nail could be assembled properly.However, it was observed that the set screw threads were severely damaged which indicates towards an improper insertion in the nail, which most likely is the reason for an inadequate insertion.If any additional information is provided, the investigation will be reassessed.
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