510k: this report is for an unknown rafn nail/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 the patient underwent a procedure on an unknown date, with retrograde approach for a poly trauma at femoral shaft.Postoperatively, there was no union of fracture noted and patient experienced an infection.Patient was polytrauma with ipsilateral pilon and contralateral plateau.Early wound complication with implanted removal of plateau and rafn and eventual bone resection and cement spacer placement.Healing around cement spacer after reconstruction with piriformis start reconstruction nail.There was an evidence of healing reported.No further information is available.This report is for an unknown rafn nail.This is report 2 of 3 for (b)(4).
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