(b)(6).Additional device product code hwc.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device was 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 on (b)(6) 2016, a patient was implanted with a short trochanteric fixation nail (tfn) due to a proximal femur fracture.On an unknown date in (b)(6) 2017, the patient experienced a fall and had a femur fracture at the site of the locking screw.The patient underwent a revision surgery on (b)(6) 2017 to replace the short tfn with a long tfn.The short nail, helical blade, and locking screw were removed intact and replaced with a long nail, helical blade, and two distal locking screws.The surgery was completed successfully with no delay and the patient outcome was reported as excellent.This report is for one (1) 11.0mm ti helical blade 95mm.This is report 2 of 3 for (b)(4).
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