If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a patient underwent an unknown procedure using a trochanteric femoral nail-advanced system (tfna) for an unknown reason.During the procedure, when the tfna nail was about to detach after insertion, the nail got stuck on an insertion handle along with the connecting screw.Thus, the surgeon replaced a new nail with other insertion handle but still, the nail got stuck from the handle.It was unknown if there was a surgical delay reported and if there was an adverse event to the patient.Procedure outcome was unknown.This complaint involves (3) devices.This report is for (1) cannulated connecting screw.This report is 2 of 3 for (b)(4).
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