Medtronic 9569166 Instructions for Use

Mast Quadrant® Retractor System 0381242E Rev. C

2016-10-25

IMPORTANT INFORMATION ON THE MAST QUADRANT® RETRACTOR SYSTEM

DESCRIPTION

The MAST QUADRANT® Retractor System is a tubular-based retraction system, designed to provide surgeons with the
freedom to retract tissue through any combination of distracting or articulating the blades. The MAST QUADRANT® Retractor

System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to
maintain the access. The system may be used in conjunction with microscopes, light sources, cameras, or other visualization
aids. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or
use are specifically excluded.

INDICATIONS

The MAST QUADRANT® Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light
sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive
approach.

The MAST QUADRANT® Retractor System is indicated for visualization of the surgical field in any area of the body cut open
during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction,

for example, the MAST QUADRANT® Retractors and accessories are intended to aid the surgeon’s visualization of the surgical
area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the
circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or
insertion of spinal implants.

CONTRAINDICATIONS

The MAST QUADRANT® Retractor System has no known contraindications intrinsic to the device. No part of the device should
ever be used in a cutting or tearing action. The device should not be inserted into body cavities, hollow organs, or natural body
openings. There are no other known risks associated with the use of the device outside of the normal and expected risks of
surgery.

DIRECTIONS FOR USE

Specific instructions for use depend on patient considerations. Therefore, Medtronic cannot provide a surgical procedure
applicable to all situations. Any available surgical procedure brochure or manual for the MAST QUADRANT® Retractor System

and for all instruments should be reviewed prior to use. The only critical directions for use are to insert the cannula or dilators
and position them in the surgical wound prior to insertion of the device. Once visualization assistance is obtained, the surgeon
can complete the planned surgical procedure.

POTENTIAL ADVERSE EFFECTS

Risks possibly associated with the use of the MAST QUADRANT® Retractor System are similar to those associated with any
surgery to the planned area of Retractor use. The most frequently stated risks are bleeding, neurological damage, damage to
the surrounding soft tissue, and infection. Each of these risks has also been used to describe the risks associated with

conventional surgical intervention. Additional risks associated with the use of the MAST QUADRANT® Retractors, other than
those described for spinal surgery in general, may be instrument malfunction, such as bending, fragmentation, loosening, and/or
breakage (whole or partial). Also, the surgery may not be effective. Similar risks are associated with the system use in other
parts of the body.

Additional risks are attendant to surgery and the use of anesthesia, etc., and are not directly related to the use of the
instruments. These include, but are not limited to, pneumonia, phlebitis, embolism, wound infection, and blood loss with or
without anemia.

WARNINGS AND PRECAUTIONS

A successful result is not always achieved in every surgical case. This fact is especially true in orthopaedic or neuro-surgery
cases where many extenuating circumstances may compromise the results.

In the event of technical complications, the surgical technique can be converted to an open procedure and the surgery
completed.

Preoperative and operating procedures, including knowledge of surgical techniques are important considerations in the
successful utilization of the system by the surgeon. Further, the proper selection of the patient and the compliance of the patient
will greatly affect the results.

In addition, the following should be considered:

1. This device is a delicate instrument. It should not be dropped, bent at a sharp angle, or exposed to any type of gamma

radiation.

2. Additional accessories should be available at the time of surgery in case of possible contamination due to mishandling or

removing the devices from the sterile field.

3. Components of the system should be thoroughly inspected during cleaning prior to surgery for possible damage.

4. Proper, secure component connections must be made to ensure proper functioning of the optical, irrigation, and aspiration

aspects of the device.

Caution: high temperature.
Typically, a light source is used in conjunction with the MAST QUADRANT® Retractors.

To reduce the risk of patient injury or damage to materials that may come into contact with this illumination system, always
ensure the heat shield is in place covering the metal cable connectors. It is recommended that this illumination system not be
used with light sources rated over 300 Watts or with fiber optic light cables larger than 5mm. However, due to inherent
differences in light and power output among light sources, we recommend the connector be monitored for elevated
temperatures. Use caution when touching the metal connectors when disconnecting the light cable after use.

For US audiences only

Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.

CLEANING PROCEDURE

Exterior cleaning is essential prior to any sterilization procedure. Dry thoroughly. Without the removal of all contaminants from
the surface, the sterilization medium will not contact the surfaces.

Warning: do not use ultrasonic cleaner or abrasives during the cleaning process.

STERILIZATION

The non-sterile instruments and instruments which are re-usable are recommended to be steam sterilized by the hospital using
one of the following methods:

If the products described in this document are sterilized by the hospital in a tray or case, it must be sterilized in a tray or case
provided by Medtronic.

Some accessories and Retractors are supplied sterile and non-reusable. Sterile product will be clearly labeled as such on the
package label. The sterility of the product supplied sterile can only be assured if the packaging is intact.

Note: the following note applies to the process parameter identified with the * below: For use of this product and Retractors
outside the US, some non-US health care authorities recommend sterilization according to these parameters so as to minimize
the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical Retractors that could come into contact
with the central nervous system.

Method: Steam Steam Steam
Cycle: Pre-Vacuum Gravity Gravity
Temperature 270°F (132°C) 250°F (121°C) 273°F (134°C)*
Exposure Time: 4 minutes 60 minutes 20 minutes*

The MAST QUADRANT® Retractors should be thoroughly cleaned prior to sterilization.
Caution: do not immerse or rinse light sources used with these instruments in cold water or any other liquid to accelerate

cooling.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

MRI INFORMATION

Medtronic instruments are not intended to be used in the magnetic resonance (MR) environment. As such, Medtronic
instruments have not been evaluated for safety and compatibility in the MR environment. Therefore, the safety of the Medtronic
instruments in the MR environment is unknown.

FURTHER INFORMATION

If there is any doubt or uncertainty concerning the proper use of this instrument, contact Medtronic. Any available surgical
techniques will be provided at no charge.

© 2016 Medtronic Sofamor Danek., Inc. All rights reserved.