(b)(4).Visual examination of the provided pictures identified metal shards, however, it is unknown from where they originated.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: plate, screw, pin and wire fixation of a complex comminuted distal humeral fracture is present.The fracture appears near anatomic in alignment.A curvilinear wire fragment or radio-opaque marker of a surgical implement is noted anteromedial to the distal humerus and does not appear connected to the humerus.There is regional soft tissue swelling.The fixation hardware is incompletely visualized but the area visualized demonstrates normal fit and alignment.Bone quality appears normal.A definitive root cause cannot be determined.
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