acumed Polarus Instrucciones De Uso página 2

US
Polarus® 3 Solution Plates And Nails
These instructions are intended for the Operating Surgeon and supporting Healthcare
US
Professionals. The US instructions are intended for users in the United States and its
territories.
DESCRIPTION
The Polarus® 3 Solution of bone plates, intramedullary nails, screws and accessories is designed to provide
fixation for fractures of the humerus while they heal.
INDICATIONS FOR USE
The Acumed Polarus® 3 Solution includes plates, nails, screws and accessories designed to address
fractures, fusions, and osteotomies of the humerus.
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
These devices are not intended for screw attachment or fixation to the posterior elements (pedicles) of the
cervical, thoracic, or lumbar spine.
WARNINGS & PRECAUTIONS
Warning:
•
For Proximal and Long Nail
nail. Do not use 3.5 mm nonlocking low-profile hexalobe screws, as there is significant risk of these
backing out. During implant removal, locate and remove the distal screws before using the Multiple
Contact Hammer. Failure to do so could result in breaking the screws, nail, or removal instrument.
• For Proximal Humerus: Standard and Posterior Plates:
hexalobe screw with a 4.3 mm low-profile hexalobe screw in the humeral head is recommended to
prevent screw migration. If dense bone is encountered when implanting 4.3 mm low-profile hexalobe
screws, a Polarus 3 4.3 mm Screw Tap (80-1623) and Polarus 3 Tap Sleeve (80-1593) are available. If
using the Posterior Plate, screws longer than 26 mm should not be used in the posterior tabs in order
to avoid screw interference. Do not bend tabs on these plates past 20 degrees; do not bend more than
once.
• For System:
While they are provided together for convenience, a plate and a nail should not be used on
the same fracture.
• 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
Instructions for use
: Use only 4.3 mm low-profile hexalobe screws in the proximal portion of the
U.S. English – US / PAGE 2
Replacing a 3.5 mm nonlocking low-profile
Rx only