This report is for an unknown nail: rfn/unknown lot.Part and lot numbers 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 an antegrade intramedullary procedure for a comminuted, shortened and varus femoral shaft fracture with structural bone loss with an associated injury of comminuted midshaft humeral fracture.There was a delayed and non union of fracture reported.No post-operative complications reported.Patient outcome is unknown.This report is for one (1) unk - nails: frn.This is report 1 of 2 for (b)(4).
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