(b)(4).Due to the intraoperative event, the device was not implanted or explanted.Per the facility, the complainant part is not expected to be returned for manufacture review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that the middle posterior hole would not lock upon insertion of a locking screw in the distal portion of a 3.7mm variable angle locking compression plate (va-lcp) during a bimalleolar ankle fracture repair procedure on (b)(6) 2016.A second screw was attempted without success; the hole was re-drilled on a different angle, but the screw would still not lock.Screw fixation on the hole was abandoned and the surgery was completed as normal.A three (3) minute surgical delay resulted, but the patient's postoperative status/outcome was reported as "fine." this report is 1 of 2 for (b)(4).
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