This report is for an unknown expert retrograde/antegrade femoral nail (rafn) distal locking screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, the patient underwent an antegrade intramedullary procedure for comminuted, displaced, femoral shaft fracture at the left periformis fossa with an associated injury of contralateral fibular fracture due to 5 gunshot wounds.There was no union of fracture reported.There was post-operative complication reported, which is the multifocal osteomyelitis of left femur.Patient had a reoperation due to removal of hardware (two distal locking screws, two proximal locking screws, intermedullary nail), debridement and placement of antibiotic nail left femur and left femur nail removal.No further information is available.This report is for an unknown expert retrograde/antegrade femoral nail (rafn) distal locking screw.This is report 4 of 5 for (b)(4).
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