Medtronic T34S Instructions for Use

Kyphon Assist™ Directional Cannula M708348B780E Rev. C

2022-05-10

IMPORTANT INFORMATION ON THE KYPHON ASSIST™ DIRECTIONAL CANNULA

Note: not all parts may be available in each geography.
Medtronic does not warrant use of instruments, accessories, or any component parts upon which repairs have been made or

attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.

PURPOSE

The Kyphon Assist™ Directional Cannula is intended for percutaneous access to bone during a surgical procedure.

INDICATIONS

The Kyphon Assist™ Directional Cannula is intended for percutaneous access to bone.

DESCRIPTION

Depending on kit configuration, some or all devices listed in this section may be present in the packaging. See Figure 1.

A. One-Step™ Osteo Introducer™ stylet with trocar tip - white handle – QTY 1
B. Kyphon Assist™ Directional Cannula (purple handle - Size 2 and Size 3) – QTY 1
C. Metal dilator – QTY 1

1. Exit marker

The exit marker is used during cannula exchange to indicate the position in which the metal dilator is flush with the end of the
working cannula.

For US Audiences Only
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Devices are intended to be a single-use disposable device, designed to be used once only and then discarded. The duration of

contact of the device with tissue is limited and is expected to never exceed 24 hours.
Physician note: although the physician is the learned intermediary between the company and patient, the important medical

information in this document should be conveyed to the patient.

WARNINGS

▪ Breakage of the device may require intervention or retrieval.
▪ Breakage, slippage, misuse, or mishandling of instruments or accessories, such as on sharp edges, may cause injury to the

patient, surgical personnel, or processing personnel.

▪ Improper maintenance, handling, or inadequate cleaning procedures can render instruments or accessories unsuitable for

the intended purpose and may present a danger to the patient, surgical personnel, or processing personnel.

▪ The surgeon should use extreme caution when working in close proximity to vital organs, nerves, or vessels. In addition,

excessive force should not be used when positioning instruments or implants, as it could cause injury to the patient.

This device was designed for single patient use only. Do not reprocess or reuse this product. Reuse or reprocessing may
compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient
injury, illness, or death.

PRECAUTIONS

▪ It is important to read the Instructions For Use and these precautions carefully prior to device operation.
▪ Take special care when accessing hard bone as the directional cannula may deflect or twist when travelling through hard

bone. Refer to Kyphon Assist™ Directional Cannula surgical guide.

▪ Components of the system should be manipulated only while under fluoroscopic observation with radiographic equipment

that provides high quality images.

▪ Insertion of the instruments requires specific knowledge 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 the Kyphon Assist™ Directional

Cannula. Use only manual power when using the Kyphon Assist™ Directional Cannula.

▪ Improper maintenance, handling, or inadequate cleaning procedures can render instruments or accessories unsuitable for

the intended purpose and may present a danger to the patient, surgical personnel, or processing personnel.

▪ Extreme care should be taken to ensure instruments and accessories remain in good working order. During the procedure,

the proper functioning of instruments and accessories is extremely important. Instruments and accessories should not be
bent or damaged. Misuse of instruments and accessories, corrosion, binding, scratching, loosening, bending, or fracture of
components of instruments or accessories may inhibit or prevent proper function.

▪ Do not use instruments or accessories for any action for which they are not intended.
▪ Regularly review the operational state of all instruments and, if necessary, contact Medtronic or an authorized Medtronic

repair representative. To avoid injury, the instrument should be carefully examined for functionality or damage prior to use.
A damaged instrument should not be used. Additional back-up instruments should be available.

▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the

successful use of instruments. Proper selection and compliance of the patient greatly affect results. Read and follow all
product information supplied by the manufacturer of devices.

▪ Extra care should be taken when using instruments in pediatric patients since these patients can be more susceptible to

stresses required in use of instruments.

▪ Ensure instruments or accessories with a measuring function are not worn and any surface markings are clearly visible.
▪ Personnel should wear all appropriate Personal Protective Equipment (PPE) as recommended by the sterilizer

manufacturer.

POSTOPERATIVE

When explanting and/or disposing of a device, avoid exposure to bodily substances such as blood, tissue, etc., as contact could
lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects and needles. Follow
your healthcare center’s policy regarding both the disposal of devices and any events of exposure.

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.

These devices should be used only by physicians familiar with the devices, their intended use, and available surgical
techniques. In addition, accessories should be used only by operators familiar with the device(s), its intended use, and
processing information.

USE OF KYPHON ASSIST™ DIRECTIONAL CANNULA (WORKING CANNULA EXCHANGE)

1. If a stylet is present in the in situ Cannula, remove the stylet by holding the in situ cannula and rotate the handle 180°

counter-clockwise to remove the stylet. Pull the stylet straight out from the in situ cannula.

2. Insert the metal dilator into the in situ cannula. Line up the exit marker on the metal dilator with the top of the in situ cannula
hub.

3. Remove the in situ cannula from the patient leaving behind the metal dilator.

4. Slide the Kyphon Assist™ Directional Cannula over the metal dilator. Line up the exit Marker on the metal dilator with the

top of the Kyphon Assist™ Directional Cannula hub.

5. Remove the metal dilator from the Kyphon Assist™ Directional Cannula.

6. If necessary, mate the Kyphon Assist™ Directional Cannula with the stylet. Rotate the Kyphon Assist™ Directional Cannula

in alternating clockwise and counter clockwise motion for insertion into bone to the desired depth. While holding the Kyphon
Assist™ Directional Cannula, rotate the handle 180° counter clockwise to remove the stylet. Pull the stylet straight out from
the Kyphon Assist™ Directional Cannula.

Note: only when using the Kyphon Assist™ Size 2 (T34S) with the Kyphon Express IBT 10/2 (K15A) and 15/2 (K15B) the
maximum inflation volumes are listed below.

Model Number K15A

Size 10/2

Max. Inflation Volume 3cc

Model Number K15B

Size 15/2

Max. Inflation Volume 4cc

Note: markings on the Kyphon Assist™ Directional Cannula may be used as reference marks only. They are not intended to
replace the use of fluoroscopic observation.

Caution: to maintain structural integrity, do not advance or rotate the Kyphon Assist™ Directional Cannula without the stylet
fully inserted. After step 6 is completed, the Kyphon Assist™ Directional Cannula is now in place and ready to accept other
instrumentation.

Note: the cutout on the Kyphon Assist™ Directional Cannula provides a platform to help direct the inflation of an inflatable
bone tamp. The direction indicator on the Kyphon Assist™ Directional Cannula indicates the side of the Kyphon Assist™
Directional Cannula where the cutout is located, but should not replace the use of fluoroscopic observation. Use fluoroscopic
observation to ensure the Kyphon Assist™ Directional Cannula is oriented in the desired direction.

Note: avoid inflating the inflatable bone tamp into the tapered section of the cutout; balloon inflation should occur on the flat
section of the Kyphon Assist™ Directional Cannula. Place the inflatable bone tamp so the distal marker band is located even
with the distal tip of the Kyphon Assist™ Directional Cannula cutout to avoid inflating into the tapered section of the cannula.
See Figures 2 and 3.

7. Upon completion of procedure, remove the Kyphon Assist™ Directional Cannula from patient.

USE AS A ONE-STEP™ OSTEO INTRODUCER™ SYSTEM

1. Make a skin incision with a scalpel blade over the selected area for access.

2. Remove and discard the protective sleeve from the Kyphon Assist™ Directional Cannula.

3. Using manual control and appropriate imaging guidance, advance the Kyphon Assist™ Directional Cannula with gentle but

firm pressure through the incision to the selected bone surface. Rotate the Kyphon Assist™ Directional Cannula in
alternating clockwise and counter-clockwise motion for insertion into bone to the desired depth.

Note: markings on the Kyphon Assist™ Directional Cannula may be used as reference marks only. They are not intended to
replace the use of fluoroscopic observation.

Caution: to maintain structural integrity, do not advance or rotate the Kyphon Assist™ Directional Cannula without the stylet
fully inserted.

Note: if Kyphon Assist™ Directional Cannula platform deflection is observed during access, retract the Kyphon Assist™
Directional Cannula and stylet from the bone and clear any excess material from the platform area prior to proceeding. If
excessive deflection of the platform is observed, a new Kyphon Assist™ Directional Cannula may be required. Additionally,
adjustment of access trajectory or access with an Osteo Introducer™ System tool may be necessary.

4. While holding the Kyphon Assist™ Directional Cannula, rotate the handle 180° counter-clockwise to remove the stylet. Pull
the stylet straight out from the Kyphon Assist™ Directional Cannula. The Kyphon Assist™ Directional Cannula is now in
place and ready to accept other instrumentation.

Note: the cutout on the Kyphon Assist™ Directional Cannula provides a platform to help direct the inflation of an inflatable
bone tamp. The direction indicator on the Kyphon Assist™ Directional Cannula indicates the side of the Kyphon Assist™
Directional Cannula where the cutout is located, but should not replace the use of fluoroscopic observation. Use fluoroscopic
observation to ensure the Kyphon Assist™ Directional Cannula is oriented in the desired direction.

Note: avoid inflating the inflatable bone tamp into the tapered section of the cutout. Balloon inflation should occur on the flat
section of the Kyphon Assist™ Directional Cannula. Place the inflatable bone tamp so the distal marker band is located even
with the distal tip of the Kyphon Assist™ Directional Cannula cutout to avoid inflating into the tapered section of the cannula.
See Figures 2 and 3.

5. Upon completion of procedure, remove the Kyphon Assist™ Directional Cannula from patient.

STERILIZATION

Devices are supplied sterile. Never in any way attempt to re-process or re-use devices supplied sterile.

VISUAL INSPECTION

Visually inspect all sterile barrier packaging before use. If the integrity of the sterile barrier has been compromised, do not use
the product. Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for
return information.

PACKAGING

Devices are supplied sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile
package has been broken, the product should not be re-sterilized. Damaged or unintentionally opened sterile products should
not be used and should be returned to Medtronic.

MRI INFORMATION

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

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the
competent authority of the Member State in which they are established.

STORAGE

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

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.

©2022 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: Kyphon Assist™ Directional Cannula Components

Figure 2: 10mm and 15mm Inflatable Bone Tamp placement

Figure 3: 20mm Inflatable Bone Tamp placement

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Authorized representative in the European Community/
European Union

Importer

This device complies with applicable European Union
regulations and directives.

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

For US audiences only

Keep dry

Do not re-use

Batch code

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

Manufacturer

Date of manufacture

Catalogue number

Sterilized using irradiation

Do not resterilize

Do not use if package is damaged and consult instructions
for use

Use-by date

Consult instructions for use at this website.

Medical device

*Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging
inside

Single sterile barrier system with protective packaging
outside

*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.