Instructions For Use - acumed Polarus Instrucciones De Uso

EN
Acumed® Polarus® 3 Solution Plates And Nails
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
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
the 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
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

Instructions for use

: Use only 4.3 mm low-profile hexalobe screws in the proximal portion of
: Standard and Posterior Plates: Replacing a 3.5 mm nonlocking low-profile
English (non-U.S.) – EN / PAGE 43