Additional narrative: 510k: this report is for an unk - end caps/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, the patient underwent an antegrade intramedullary procedure for comminuted proximal femur fracture.The injuries were associated to sciatic nerve, profund of a femoris artery.Other complication includes right foot drop, short segment high-grade stenosis of the distal right superficial femoral artery.There was no infection, non-union and malalignment noted.Concomitant devices reported: unknown recon screws (part# unknown, lot# unknown, quantity unknown), unknown locking screws (part# unknown, lot# unknown, quantity unknown), unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1) unk - end caps.This is report 3 of 3 for complaint (b)(4).
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