It was reported that a revision surgery was performed due to the non-union of a fracture.On (b)(6) 2013, the patient was treated for a distal femur fracture with one 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate, two cortex screws and ten locking screws.The patient returned on (b)(6) 2014 to have the 4.5mm va-lcp curved condylar plate removed due to a non-union of the fracture and to revise it with a retrograde/antegrade femoral nail (rafn).The plate and eleven of the screws were removed without any issues.One 68mm long, 4.5mm cortex screw self-tapping was found to be broken at the head of the screw, but was easily removed using locking pliers.This delayed the surgery no more than 5 minutes.All other implanted devices were removed and the surgeon performed the revision by implanting the rafn in the patient.The procedure was completed successfully with no patient harm reported.This report is 12 of 13 for complaint (b)(4).
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Device was used for treatment, not diagnosis.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.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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