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 visual inspection of the received device i.E., nail handle was found to be damaged and worn out around the head of screw insertion.The surface around the pegs is worn out, and the pegs have blunt corners on the inner side.Due to the nature of the returned device, a functional inspection was not possible because the pegs are deformed.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.The information for use states that ¿do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate!¿.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by handling failure during disassembling which led to damage of nail holding screws eventually impairing disassembling with nail handle.If any further information is provided, the complaint report will be updated.
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