This report is for an unknown rafn spiral blade/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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 was implanted with an expert retrograde/ antegrade femoral nail to treat a femoral shaft fracture.Approximately 73 days after implantation, it was confirmed that there was a bone union.The post operative complication presented was deep vein thrombosis (dvt).Patient outcome is unknown.No further information is available.This report is for one (1) unknown rafn spiral blade.This is report 3 of 4 for (b)(4).
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