Investigation results: visual investigation: we made a visual inspection of the screw parts, especially the insert.The screw itself exhibit damages and deformations in the hexagon.The body shows no damages or abnormalities.The insert shows bent catch noses.It is plain to see, that the plate with the catch nose is bent.With this nose out of alignment a reliable catch of the insert in the body is no longer given.For a better comprehension, an excerpt of the construction drawing is attached.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.Conclusion and measures / preventive measures: without further knowledge about the circumstances, we assume, that the plate was deformed during the surgery by wrong handling.The reason for this is probably a not proper attached hex key tip.The damaged / deformed hexagon in the screw head is a sure hint for this assumption.According to the batch history record the product left aag in a condition according to specification.A material defect or a manufacturing error can be excluded.Based upon the investigations results a capa is not necessary.
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