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.