Contraindications - Neoligaments Infinity-Lock Button System Anwendung

English
Ordering Information (supplied sterile)
102-1089 Infinity-Lock Button System:
TM
Infinity-Lock Tube-Tape, 7 mm x 240 mm
Infinity-Lock Button, 4 mm x 12 mm
Cannulated drill bit, plain shank to fit Jacobs chuck,
4.0 mm diameter x 120 mm
Guidewire, diameter 2.0 mm x 150 mm
Optional Disposable Instrument:
202-1411 CC-Hook, with a curved end, Left
202-1413 CC-Hook, with a curved end, Right
Patient Information
The following information is provided for use by
clinicians, however as the learned intermediary
between the company and the patient, the clinician
must convey the aspects they consider relevant to
the individual patient. The patient must be informed
of the potential adverse effects (risks/complications)
contained in this insert (see POTENTIAL ADVERSE
EFFECTS).
Description
The Infinity-Lock Button System comprises a
permanent implantable 240 mm Tube-Tape and
titanium alloy Button together with a disposable
cannulated drill bit and guidewire. A coracoid passer
suitable for passing the tape around the coracoid, such
as the Neoligaments CC-Hook, is also required.
Clinical evaluation supports the following
clinical benefits:
• Shoulder reduction;
• Cosmetic improvement;
• Improved functional outcome;
• Reduction in pain;
• Return to work/sports.
Testing has shown the following:
Mean Ultimate Tensile
Strength (N)*
Mean Ultimate Tensile
Stength post fatigue (N)*
*data on file at Xiros
The device is intended to be used by trained surgeons.
1054 (SD = 75)
1263 (SD = 97)
Material Specifications
The Tube-Tape is made from 100% polyethylene
terephthalate (polyester) and the Button from 100%
implant grade titanium alloy (Ti-6AI-4V) to ISO 5832-3.
The cannulated drill and guidewire are made
from stainless steel 17-4PH (ASTM F899) and 316
(ASTM A262) respectively. These materials meet
applicable specifications established by BS EN ISO
10993-1: 2009 Biological evaluation of medical
devices and are appropriate for their intended use.
Intended Use
The Infinity-Lock Button System is intended
to provide fixation during the healing process
following a syndesmotic trauma, such as fixation of
acromioclavicular separations due to coracoclavicular
ligament disruption.
Indications For Use
The Infinity-Lock Button System is indicated for patients
with acromioclavicular separations resulting from
disruption to the coracoclavicular ligaments.

Contraindications

• Known hypersensitivity to implant materials. If the
patient is suspected of having any foreign body
sensitivity, appropriate tests should be made prior
to implantation.
• Infections or any structural or pathological
condition of the bone or soft tissue that would be
expected to impair healing or secure fixation.
• Patients unable or unwilling to restrict activities
to prescribed levels or follow a rehabilitation
programme during the healing period.
• Skeletally immature patients are not suited as the
Infinity-Lock will not elongate with growth. The use
of this medical device and placement of hardware
or implants must not bridge, disturb or disrupt the
growth plate.
Warnings
• The Infinity-Lock Button System is provided sterile
and remains so unless the packaging is damaged
or opened. Store in standard conditions. DO NOT
RESTERILIZE.
• The Infinity-Lock Button System is for single use
only as it would be damaged by reprocessing
and the instruments are subject to wear. Do not
use after the expiration date. Discard any open,
unused product.
• The surgeon must be thoroughly familiar with
these instructions and the surgical technique
recommended overleaf before using the Infinity-
Lock Button System.