Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via visual inspection of returned product.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was also reported that the cage was impacted with straight impactor via high amount of force.Conclusion: the root cause of the reported event was determined to be user error- too much impaction force.
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