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.Reporter is a synthes employee.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 supracondylar fractures including those with intraarticular extension and pending pathologic fracture at supracondylar femur.Postoperatively, there was an unknown union of fracture noted and patient has passed away after 7 weeks later from multiple myeloma disease.Patient had severe multiple myeloma disease with a distal medial cortical erosion.Patient underwent prophylactic retrograde nailing without complication.There was no evidence of healing reported.No further information is available.This report is for an unknown rafn nail.This is report 4 of 4 for (b)(4).
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