This report is for an unknown nail head elem: rafn spiral blade/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 a procedure with a retrograde approach for a polytrauma.Postoperatively, there was a union of fracture noted and patient experienced osteomyelitis in right upper extremity.There was an evidence of healing reported.This report involves one (1) unknown nail head elem: rafn spiral blade.This is report 2 of 4 for (b)(4).
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