INION OTPS Gebrauchsanweisung

12000130 (10/2019-04-01)
ENGLISH
INION OTPS™ BIODEGRADABLE FIXATION SYSTEM
INSTRUCTIONS FOR USE
DESCRIPTION
The INION OTPS™ BIODEGRADABLE FIXATION SYSTEM consists of fixation plates, meshes and screws made of degradable co-
polymers composed of L-lactic acid, D-lactic acid, and trimethylene carbonate. These polymers have a long history of safe medical use and
they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants gradually loose their strength
during 18-36 weeks in vivo. Bioresorption takes place within two to four years.
The INION OTPS™ biodegradable implants are offered in different sizes and are designed to be used with customized instrumentation, the
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INION bone drill bits, bone taps, countersinks, depth gauges, screwdrivers, plate bending pliers and heating devices.
The INION OTPS™ implants are sterile and non-collagenous.
INDICATIONS
A. General indications: These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are generally intended for maintenance of
reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of
appropriate plaster cast immobilization.
B. Specific indications:

Fractures and osteotomies of the malleoli

Ankle fractures

Diaphyseal fractures of the ulna and radius
CONTRAINDICATIONS
These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are not intended for use in and are contraindicated for:
• Active or potential infection.
• Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be
guaranteed (e.g., alcoholism, drug abuse).
• High-load bearing applications.
INFORMATION FOR USE
Surgical considerations and reminders
• Prophylactic perioperative antibiotic treatment is recommended.
• Use proper local, regional or general anaesthesia.
• Maintain sterile field throughout the procedure.
• Proper exposure using standard surgical procedure.
• Thoroughly prepare the surgical site preserving the neurovascular structures by careful dissection.
• Good alignment/reduction of the fracture/osteotomy.
• Radiographs can be taken to check the alignment/reduction after fixation.
• Meticulous hemostasis and complete primary soft tissue closure over the implant are essential.
Preparation of the plates
The plates should be contoured to the bone according to these instructions (see also the instructions for use of the INION THERMO+™
water bath):
• Place a sterile INION THERMO™ drape to the INION THERMO+™ water bath. DO NOT switch on the water bath until filled with liquid!
• Pour sterile water or saline (min 0.4 litres max 0.7 litres) into the waterbath.
• Switch the water bath on. Wait until the liquid heats up to the setting temperature 70°C / 158°F, this takes about 30 minutes.
• Choose appropriate INION OTPS™ BIODEGRADABLE FIXATION SYSTEM plate for the indication.
• Immerse the plate in the water bath for approximately one minute. After water bath treatment: The plate is most malleable for 10-15
seconds, can be shaped as desired and may be cut to the desired size with standard surgical scissors.
• Maximum total immersion time of the plate/mesh in the waterbath is 30 minutes. Prolonged immersion may weaken the plate/mesh.
• Place the plate against bone at its intended location. Contour the plate to desired shape using fingers and/or the INION
pliers.
• If contouring is not satisfactory, the water bath treatment can be repeated. If only part of the plate needs further adaptation dip only that
portion of the plate or bend once cooled.
• Repeated bending can weaken the plate, especially once cooled. Warm bending can be carried out up to three times.
• Take care not to perforate the INION THERMO™ drape with surgical instruments.
• Take care to ensure that the plate is accurately adapted to the bone contours.
• DO NOT use plate(s) that show signs of damage!
• DO NOT activate the screws by heating in the water bath!
Fastening of the plates
• Choose appropriate INION OTPS™ BIODEGRADABLE FIXATION SYSTEM screws for fixation of the plate(s). If needed, the screws can
be cut to desired length with standard surgical scissors. Always insert screws through the plate holes closest to the fracture/osteotomy line.
NOTE: Always rinse the drill hole before screw insertion.
• DRILL & MANUAL TAP METHOD:
• Using the appropriate (corresponding to the screw diameter) INION
2000 rpm), drill a suitable hole for the screw into the bone. Use irrigation. Always drill the holes for the screws through the holes of
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drill bit attached to a slow speed drill (maximum speed of
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plate bending