acumed Nail 2 System Gebrauchsanweisung Seite 2

US
Fibula Nail 2 System, Ulna Nail 2 System
These instructions are intended for the Operating Surgeon and supporting
US
Healthcare Professionals. The US instructions are intended for users in the
United States and its territories.
DESCRIPTION
Acumed Fibula and Forearm Nail 2 System includes Fibula Nail 2 and Ulna Nail 2 implants and instruments
for fixation of fractures and osteotomies of the fibula and ulna.
INDICATIONS FOR USE
The Acumed Fibula and Forearm Nail 2 System, consisting of Fibula Nail 2 and Ulna Nail 2 implants
and instruments is intended for fixation of fractures and osteotomies of the fibula and ulna
respectively, including fractures where the medullary canal is narrow, or flexibility of the implant is
paramount.
CONTRAINDICATIONS
• Active or latent infection
• Sepsis
• Insufficient quantity or quality of bone, osteoporosis
• Soft tissue or material sensitivity
• Patients who are unwilling or incapable of following post-operative care instructions
WARNINGS & PRECAUTIONS
Warning:
• The treatment or implant may fail, including sudden failure, as a result of:
• Loose fixation and/or loosening
• Stress, include stress from inappropriate bending of the implant during surgery
• Stress concentrations
• Stress of weight bearing, load bearing, or excessive activity
• Failure is more likely if the implant experiences increased loads due to delayed union, nonunion, or
incomplete healing. Failure is more likely if the patient does not follow post-operative care
instructions.
• Nerve or soft tissue damage may result from surgical trauma or the presence of an implant.
•
Instrument breakage or damage, as well as tissue damage, may occur when an instrument is
subjected to excessive loads, excessive speeds, dense bone, improper use or unintended use.
• Implants may cause distortion and/or block the view of anatomic structures on radiographic images.
•
Allergic reactions may occur for patients with confirmed material sensitivity to implant
materials.
Instructions for use
U.S. English – US / PAGE 2
Rx only