Actual completed date: (b)(6) 2019 sign-off comment the returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows a first pass suture passer which was returned with an detached top jaw.During the functional evaluation the ratchet release and the lever were tested without issue.Further functional test cannot be verified due to the missing component the complaint was verified and the root cause could not be properly determined.However likely cause could be (1) mechanical component failure (2) excessive force used (3) tissue thickness.
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