DePuy Synthes RIGIDLOOP Manuel D'utilisation page 2

ENGLISH
RIGIDLOOP
Adjustable Cortical
Fixation System
DESCRIPTION
The RIGIDLOOP™ Adjustable Cortical Fixation System provides
a means of suspensory fixation of tendons and ligaments in
orthopaedic reconstructive surgery. The device consists of a
titanium implant with a pre-attached, non-absorbable adjustable
suture construct. The implant is preloaded with a green-and-
white striped leading suture (ultra high molecular weight
polyethylene (UHMWPE) and polyester (PET) cobraid) and a
green PET trailing utility suture.
Product Code
232447
232448
232449
MATERIALS
Metal component of implant:
ASTM standard F136.
Adjustable loop of implant: UHMWPE
Leading suture: UHMWPE and PET (D&C Green #6)
Trailing suture: PET (D&C Green #6)
INDICATIONS
The RIGIDLOOP Adjustable Cortical Fixation System is
indicated for fixation of soft tissue to bone in Femoral Cruciate
Ligament Reconstruction.
CONTRAINDICATIONS
• Physical conditions which would eliminate, or tend to
eliminate, adequate implant support or retard healing,
(e.g., blood supply limitations, infections).
• Implant/material sensitivity/foreign body sensitivity.
• Conditions which tend to pre-empt the patient's ability or
healing period, such as senility, mental illness or alcoholism.
WARNINGS
• Do not re-sterilize. The components are provided sterile, for
single use only. This product has not been designed to be
reused/re-sterilized. Reprocessing may lead to changes in
material characteristics such as deformation and material
degradation which may impact the strength of the implant
and compromise device performance. Reprocessing of single
use devices can also cross-contaminate leading to patient
infection. These risks may potentially affect patient safety.
• Do not attempt clinical use of the device before reviewing the
instructions for use.
PRECAUTIONS
• Contents sterile unless package has been opened or damaged.
• Do not use 232447 or 232448 with passing tunnels that
exceed 4.5mm in diameter. The Adjustable Cortical XL Implant
(232449) is available for passing tunnels that breach the cortex.
™
Description
RIGIDLOOP Adjustable Cortical Implant, Standard
RIGIDLOOP Adjustable Cortical Implant, Long
RIGIDLOOP Adjustable Cortical XL Implant
Titanium alloy which meets
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