Orthofix TrueLok, Instruction Leaflet

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Instruction leaflet - Please read prior to use
TrueLok
External fixation system
RX Only
Important information for the surgeon performing the operation
Read instructions before use
General information
The Orthofix TrueLok is a modular circular external fixation system consisting of rings, partial rings, posts,
plates, hinges, distraction elements, connection elements, half-pins, wires, and fixation bolts. The rings and
partial rings are manufactured from aluminum. The linear distractors are manufactured from aluminum,
stainless steel, and nylon. The angular distractors are manufactured from aluminum, stainless steel, and
Techron PPS. All other elements are manufactured from stainless steel. The system is used with 1.8mm K-wires
and bone screws manufactured by Orthofix Srl. This external fixation system is a metal bone fixation device
for stabilisation and correction during the normal healing process. The purpose of the fixation devices is
to keep the bone segments aligned during the healing process; they are not designed to support weight
bearing loads. The device may only be applied by a physician with adequate surgical knowledge of the system
and its relative mechanical limitations. The selection of the correct frame and implant size for each patient
is fundamental for the success of the procedure. The metal screws and wires are subject to repeated stress
during use and their resistance will be limited by the size and shape of the bones being treated. Unless care is
taken in patient selection, proper placement of the frame hinges, wires and screws, and careful postoperative
management to minimise the stresses on the frame, metal fatigue may occur, with consequent breakage or
bending before the healing process is complete, which may result in further injury or the need to remove the
device prematurely.
While using the TrueLok system for bone fixation, the surgeon should keep the following in mind:
• Patient weight: an obese or overweight patient places loads on the device that could cause breakage or
bending.
• Patient occupation or activity: the risk of bending or breakage of an internal or external bone fixation device
during post-operative rehabilitation may increase if the patient carries out activities that involve lifting or
heavy muscular activity, as these movements subject the device to forces that could cause it to break.
• Mental condition of the patient: the risk of breakage of a fixation device is greater in older patients, or
patients with mental deficiency, alcoholics or drug addicts or patients who, for other reasons, may ignore
the necessary restrictions and precautions to be observed while using the device.
• Patient sensitivity to certain material: if it is suspected that the patient is sensitive to the used material,
suitable tests must be carried out before selecting or implanting the material.
EN