H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A visual inspection of the returned device found that the meniscal loops were both separated from the handles.The complaint was confirmed, and the root cause was associated with device design.A corrective action for this failure mode is in place.
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