Additional information - d4 (lot #), d9, h4.Investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.There are corrosion residues on the surface, most likely from reconditioning.The jaw cutting edge is damaged on both sides.The spring and one spring fixing screw are broken.The broken parts, except for one, are not available for examination.The remainder of the spring mounting screw is still in the threaded hole.This type of corrosion on the products is called a "stress corrosion" which occurs in conjunction with a mechanical stress and often affects areas or components subjected to high tensile stresses.This may be due to design limitations, such as threaded connections.Reprocessing the instrument under high tensile stress may accelerate the defect.Instruments with hairline cracks in the connection areas as well as instruments that are damaged, deformed or otherwise worn must be replaced as their function is no longer fully or sufficiently guaranteed.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results, a capa is not required.
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