Evaluation revealed the long nail and the nail holding screw to be the primary products.The target device returned is considered to be an associated product.As mechanical properties of material and dimensions were within specified tolerances we exclude material and manufacturing deviations.Performed pre-op check revealed the returned devices being fully functional.During pre-op check, the three returned devices could be assembled and disassembled without excessive force as intended.The subject of the reported event could not be reproduced.Signs of seizing / fretting corrosion were not found on the items.The threads of nhs and nail are in good condition.Referring to the subject of the complaint it cannot be excluded that the nhs had been screwed in the nail with excessive force.Possibly, in this case the torsional force had not been applied constantly to the nhs but with a quick movement which would explain the relatively high loosening torque whilst disassembling the items.All relevant information for a comprehensive investigation has been repeatedly requested, but it was not provided.Thus, the investigation is based on the details given within product inquiry, only.However, based on the information given an exact root cause of the reported event could not be determined.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
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