acumed Nail 2 System Gebrauchsanweisung Seite 41

EN
Fibula Nail 2 System, Ulna Nail 2 System
These instructions are intended for the Operating Surgeon and supporting Healthcare
EN
Professionals. The EN instructions are intended for users in English speaking countries
outside 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.
Caution:
• The implants and instruments are intended only for professional use by a licensed physician.
• Do not use or re-sterilize an implant provided in sterile packaging if the package has been damaged.
The sterility may be compromised and the cleanliness of the implant may be uncertain. Report damaged
packaging to your distributor or Acumed.
Instructions for use
English (non-U.S.) – EN / PAGE 41