This report is for an unknown 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.
|
It was reported that the patient underwent a procedure on an unknown date, with retrograde approach for an ipsilateral hip/shaft at femoral shaft and displaced femoral neck.Postoperatively, there was a union of fracture noted and the patient had a meralgia parasthetica occur from a new trauma at late follow up.There was an evidence of healing reported.No further information is available.Patient consequence is unknown.No surgical delay.This report is for an unknown rafn spiral blade.This is report 2 of 4 for (b)(4).
|