Medtronic T01A Instructions for Use

Part Number M708348B129 Rev A 2011-10

INSTRUCTIONS FOR USE

KYPHON® Introducer Tool Kit

INDICATIONS FORUSE

The KYPHON® IntroducerTool Kit(ITK) is intended only for percutaneous accessto bone, including use during a
balloon kyphoplasty procedure.

DEVICE DESCRIPTION

See Figure 1.

• (2) Blunt Guide Pin (A)

• (1) Blunt Dissector (B)

1. Flange

2. Notch

• (2) Cannula (C)

3. Flange

• (1) Precision Drill (D)

4. Flange

5. Notch

• (1) Slip-Loc® Handle (E)

6. Slots

Caution: Federallaw (USA) restricts this device to sale by or on the order of a physician.

WARNINGS

Breakage of the device may require intervention or retrieval.

PRECAUTIONS

• The KYPHON® IntroducerTool Kit is a single use device intended to contact body tissues. Do not reuse,reprocess,
or resterilize.Reusingthis device carries the risk of contaminationand may cause patient infection or cross­infection,regardless of the cleaningand resterilizationmethods. There is also an increased risk of the
deterioration of the device performancedue to the reprocessingsteps,which may lead to patientinjury or death.

• It is important to read the Instructions For Use and these precautions carefully prior to device operation.

• Do not use if package is opened or damaged because product integrity including sterility may be compromised.

• Use the KYPHON® ITK prior to the use by date noted on the package.

• Do not use damaged products. Before use, inspect the KYPHON® ITK and packaging to verify that no damage
has occurred.

• Do not use this product if you have not been properly trained in its use. Physicians using the KYPHON® ITK
should be familiar with the physiology and pathology of the selected anatomy and be trained in the
performance of the chosen surgical technique.

• ITK should be manipulated only while under fluoroscopic observation with radiographic equipment that
provides high quality images.

• Access to the vertebral body via the pedicle requires a minimum pedicle width of 5 mm. Insertion of the
instruments requires specific knowledge of the dimensions of the site of insertion to bone as assessed by MRI,
CT or other imaging method.

• Never use electric power (or any other alternative power sources) in conjunction with KYPHON® ITKs or
Precision Drill. Use only manual power when using the KYPHON® ITK or Precision Drill.

• Reconditioning, refurbishing, repair,modification, or resterilization of the device to enable further use is
expressly prohibited.

ADVERSE EVENTS

Adverse events potentially associated with use of the device include:

• Nerve injury including puncture of the spinal cord or nerve roots potentially resulting in radiculopathy, paresis
or paralysis

• Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical
sequelae

• Hemothorax or pneumothorax

• Deep or superficial wound infection

• Unintended puncture wounds including vascular puncture and dural tear

• Bleeding or hemorrhage

• Hematoma

• Pain

DIRECTIONS FOR USE

1. Once access to the bone is achieved, using the KYPHON® 11 Gauge Bone Access Needle (not provided here),
insert the guide pin into the lumen of the KYPHON® 11 Gauge Bone Access Needle stylus. Using fluoroscopic
image guidance, advance the guide pin to the desired location within the bone. Withdraw the access needle
stylus, leaving the guide pin in the desired location.

2. Advance the blunt dissector over the guide pin so that the guide pin is contained within the center lumen of
the blunt dissector. Under imaging guidance using manual control, advance the blunt dissector through soft
tissues into the selected bone. Manual control may be improved by placement of the Slip-Loc® handle on the
proximal end of the blunt dissector. A surgical mallet may be used to tap the Slip-Loc® handle for insertion of
the blunt dissector.

3. Advance the cannula over the blunt dissector such that the blunt dissector is contained within the center
lumen of the cannula. Under imaging guidance using manual control, advance the cannula through the soft
tissues into the selected bone.

NOTE: Markings on the devices may be used as reference marks only; they are not intended to replace the use of
fluoroscopic imaging.

4. Manual control of the cannula may be improved by placement of the Slip-Loc® handle on its proximal end. A
surgical mallet may be used to tap the Slip-Loc® handle for insertion of the cannula.

CAUTION: To maintain structural integrity, do not advance the cannula without the blunt dissector inserted.

5. Remove the blunt dissector and guide pin from the cannula. Use the proximal end notch of the blunt dissector
with the Slip-Loc® handle slot for removal as needed.

6. Advance the Precision Drill so that the Precision Drill is contained within the center lumen of the cannula.
Attach the Slip-Loc® handle to the Precision Drill by insertion of the handle to the proximal end flange of the
Precision Drill. Under imaging guidance using manual control, rotate and advance the drill into the bone to the
desired depth.

7. Remove the Precision Drill by rotation from the cannula. Use the proximal end notch of the Precision Drill with
the Slip-Loc® handle slot for removal as needed.

8. Upon completion of procedure, remove cannula from patient. Insert the cannula proximal flange to the Slip­Loc® handle slot for cannula removal as needed.

STERILIZATION

Sterilized with irradiation.

HOW SUPPLIED

The KYPHON® ITK is supplied sterile in a peel-open package. In the event of damage to the sterile packaging, do
not use and notify the manufacturer.

MATERIALS NOT SUPPLIED

KYPHON® 11 Gauge Bone Access Needle.

STORAGE

The instruments should be stored in their original shipping materials. Proper care should be taken to ensure that
the instruments will not be damaged. Store in a cool dry place.

LIMITATION OF LIABILITY

MEDTRONIC WILL NOT BE RESPONSIBLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY
DAMAGES RESULTING FROM REUSE OF THE KYPHON® INTRODUCER TOOL KIT.

IN NO EVENT SHALL MEDTRONIC BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR
EXEMPLARY DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE KYPHON® INTRODUCER TOOL KIT, BASED
UPON BREACH OF CONTRACT (INCLUDING BREACH OF WARRANTY).

REQUESTS FOR INFORMATION

For further information, please contact Customer Service, Sofamor Danek USA, Inc., 1800 Pyramid Place, Memphis,
Tennessee 38132, Telephone: [phone] (in U.S.A.), 901 396 3133 (outside U.S.A.), Fax [phone].

© 2011 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Sterilized Using Irradiation Consult Instructions for Use

Do Not Resterilize Use-by

Batch Code Do Not Use if Package is Damaged

Catalogue Number Manufacturer

Do Not Reuse For U.S. audiences only

Caution: Federal law (U.S.A.)
restricts these devices to sale by or
on the order of a physician

Figure 1: KYPHON® Introducer Tool Kit

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (in U.S.A.)

901 396 3133 (outside U.S.A.)
Fax [phone]