Medtronic SPS02340 Instructions for Use

MARROWMAX BONE MARROW ASPIRATION

NEEDLE KIT

NeedleTech Products, Inc.

452 John L. Dietsch Blvd.
No. Attleboro, MA 02763 USA
Telephone: [phone]
Fax [phone]

ENGLISH

IMPORTANT INFORMATION ON THE

MARROWMAX BONE MARROW ASPIRATION NEEDLE KIT

PURPOSE

Designed specifically for bone marrow aspiration and/or autologous blood, the MARROWMAX Bone
Marrow Aspiration Needle Kit provides a safe and simple technique for aspirating marrow and/or
autologous blood.

The product label for the MARROMAX Bone Marrow Aspiration Needle Kit configuration uses symbols to
convey essential product information. Each symbol is defined in Table 1.

SYMBOL MEANING

Rx Only





Table 1: Definition of Symbols

Caution, Federal (US) Law restricts this device to sale by or on the order of a licensed
physician

Do not reuse
Use by












NEEDLETECH PRODUCTS, INC. Page 1 of 3

Batch code
Manufacturing date

Catalog number
Sterilized using ethylene oxide

Do not use if package is damaged

Consult instruction for use

Manufactured by

DESCRIPTION

The MARROWMAX Bone Marrow Aspiration Needle Kit consists of 1 FDA cleared and 1 legally marketed
device; the Becton Dickinson Single Use Hypodermic Syringes (K980987) and the NeedleTech Products,
Inc. Bone Marrow Biopsy Needle (510K Exempt).

The NeedleTech Products, Inc. Bone Marrow Biopsy Needle consists of a needle and a trocar tip stylet of
corresponding size. The needle will be manufactured with a length of 6 inches. The needle contains a
female Luer-lok™ connection to allow aspiration of bone marrow and/or blood by use of a standard Luer­lok™ surgical syringe. The needle will be provided with three fenestrated holes located on the distal end
of the cannula. There will be another needle available with one fenestrated hole on the distal end of the
cannula.

NeedleTech Products, Inc. Bone Marrow Biopsy Needle will be packaged in a kit that will include a 10mL
or 20mL BD Luer-Lok™ syringe.

Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

INDICATIONS

The MARROWMAX Bone Marrow Aspiration Needle Kit is a stylet/cannula system to be used to obtain
bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

CONTRAINDICATIONS

The MARROWMAX Bone Marrow Aspiration Needle Kit should not be used in the presence of active or
suspected infection.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to wound complications including hematoma, site
damage, infection, bone fracture, and other complications common to any surgical procedure.

WARNING(S) and PRECAUTIONS

Use aseptic technique in all phases of handling.

PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the
patient, the important medical information given in this document should be conveyed to the patient.

USA

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.

NEEDLETECH PRODUCTS, INC. Page 2 of 3

FOR US AUDIENCES ONLY

PACKAGING

This product is provided sterile. Packages for each of the components should be intact upon receipt.
Once the seal on the package has been broken, the product should not be re-sterilized. All kits should be
carefully checked for completeness and all components should be carefully checked to ensure that there
is no damage prior to use. Damaged packages or products should not be used, and should be returned to
NeedleTech Products, Inc.

STERILIZATION

Devices are supplied in a sterile form and are for single use only. Once the seal on the package has been
broken, the product should not be re-sterilized.

SINGLE USE ONLY, DO NOT RESTERILIZE, DO NOT REUSE.

HOW TO USE THE DEVICE

1. Begin by determining the bone site.

2. Using sterile technique, prepare surgical site similar to that of iliac crest harvesting.

3. Make a small stab incision, to be used for needle insertion.

4. Remove the plastic guard from the aspiration needle. Unlock and remove the trocar stylet to
ensure proper function. Reinsert the stylet and lock it into place.

5. Percutaneously introduce the aspiration needle into the iliac crest. To stabilize the needle and
enhance user control, hold the proximal end of the T-Handle in palm and place the index finger
against the shaft of the trocar cannula near the crown.

6. Use gentle but firm pressure to advance the trocar cannula. Rotate trocar cannula 45° in
alternating clockwise–counterclockwise motion.

7. Decreased resistance is experienced upon entrance into the marrow cavity. If the trocar cannula
is advanced beyond the marrow cavity, aspiration of marrow will be prevented.

8. Should this occur, slowly withdraw the trocar cannula from the opposing iliac crest wall while
rotating the trocar cannula 45° in alternating clockwise–counterclockwise motion until marrow can
be aspirated.

9. Remove the trocar stylet from the hollow cannula.

10. Attach the syringe included in the kit to the hub of the aspiration cannula.

11. Aspirate the desired amount of marrow by retracting the syringe plunger.

12. To maintain the highest quality marrow, a maximum of 3mL of marrow should be withdrawn from
any one aspiration site.

13. If more marrow is needed, move the cannula 1cm along the iliac crest and repeat steps 2 through
6 as needed.

14. Once the desired volume of marrow has been collected, remove the syringe from the cannula.

15. Remove cannula from wound and close wound using standard surgical technique.

PRODUCT COMPLAINTS

Any Health Care Professional (e.g., customer or user of this system of products), who has any complaints
or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety,
effectiveness and/or performance, should notify the distributor or NeedleTech Products, Inc. If any
product ever “malfunctions” and may have caused or contributed to the death or serious injury of a
patient, the distributor should be notified immediately by telephone, fax or written correspondence. When
filing a complaint, please provide the component(s) name and number, lot number(s), your name and
address, the nature of the complaint and notification of whether a written report from the distributor is
requested. For more information please contact NeedleTech Products, Inc. at:

NeedleTech Products, Inc.
452 John L. Dietsch Blvd.
No. Attleboro MA, 02763, USA
Phone: [phone]
Fax: [phone]

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