(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was returned for evaluation.A visual exam was performed and it was observed that the blade was broken.It is unknown where the damage occurred as all products are inspected at the manufacturing facility prior to shipment; therefore, a defect of this type would be detected prior to release.The complaint was confirmed; however, a root cause could not be established.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
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