Affixus Natural Nail System Humeral Nail PMCF

Eligibility Criteria

• * Patients 18 years or older and skeletally mature.
• * Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
• * Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail.
• * Patient must be able and willing to complete the protocol required follow-up.
• * Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.)
• * Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
• * Distal fracture involving the olecranon fossa.
• * Bone shaft having excessive bow or deformity.
• * A medullary canal obliterated by a previous fracture or tumor.
• * Active or previous infection.
• * Skeletally immature patients.
• * All concomitant diseases that can impair the functioning and the success of the implant.
• * Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions.
• * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
• * Patient known to be pregnant or breast feeding.
• * Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
• * Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study.
• * Not expected to survive the duration of the follow-up program.