Medtronic 6061006 Technical Manual

™

ACCELERATE
GRAFT DELIVERY
SYSTEM WITH
GRAFTON™ DBF

USER GUIDE

Graft material inside of Cannula shown for visual ization

TABLE OF

CONTENTS

3 Introduction

4 Instrument and Implant Information

4 Instruments and Implants

4 Technical Specifications

5 Procedure

5 Tips

6 Graft Preparation

™

7 Filling the Accelerate

8 Loading the Accelerate

9 Attaching the Accelerate

10 Delivery of the Bone Graft Mixture

11 Reloading and Disassembly

Cannula with the Bone Graft Mixture

™

Cannula into the Accelerate™ Funnel

™

Funnel to the Accelerate™ Body

12 Graft Recovery

13 Product Ordering Information

14 Instructions for Use (IFU)

2

INTRODUCTION

The Accelerate™ Graft Delivery System was developed and designed to empower the healthcare professional to leverage
the delivery of autograft combined with Grafton™ DBF. The seamless, simplified, and integrated delivery of bone graft with
the Accelerate™ Graft Delivery System enables controlled delivery in an efficient workflow. This User Guide is designed to
familiarize healthcare professionals with the use of Accelerate™ Instrument Set. Please carefully read this User Guide and
its appendix prior to use of the instruments and implants.

The development and design of the Accelerate™ Graft Delivery System revolved around a comprehensive solution to bone
grafting that focused on – the instrument, the implant, and the workflow.

Accelerate™ Design Pillars

LEVERAGE
AUTOGRAFT

EFFICIENT
WORKFLOW

Risks

See IFU for a full list of risks, warnings, and contraindications.

CONTROLLED
DELIVERY

3

INSTRUMENT AND IMPLANT

INFORMATION

Instruments and Implants

Distal end Proximal end

Accelerate

Cannula

Accelerate

™

Funnel

™

Graft Delivery Loading Platform

Pin

open

closed

Socket

Standard Bone Funnel

Accelerate

Accelerate

™

Graft Recovery Tool

™

Graft Recovery Platform

Clasp

Plunger

Release mechanism

Trigger Back handle

Accelerate

™

Funnel Pin

Technical Specications

Cannula

Cannula Bone Graft Capacity 6.0cc

Accelerate

Accelerate™ Funnel Outer Diameter 7.9mm
Accelerate

™

Funnel

™

Funnel Shaft Length 7.1"

Accelerate

4

™

Body

Standard Bone Funnel

Standard Bone Funnel Inner Diameter 6.85mm
Standard Bone Funnel Outer Diameter 8.5mm
Standard Bone Funnel Shaft Length 7.3"

PROCEDURE

Tips

1 The Accelerate™ Instrument will clog if the bone chip

size exceeds 3.2mm in diameter.

2 Use Accelerate™ Graft Delivery Instrument as intended

only with Grafton™ DBF. Use with other products

(mineralized allograft, synthetics, dierent bone

graft formulations, etc.) will likely result in decreased
performance, clogging, and possible permanent
malfunction.

™

3 Only use Accelerate

BG Set T502XX Grafton™
DBF. The original T501XX Grafton™ DBF will not be
compatible as it does not contain the Cannula.

™

4 The Accelerate

Graft Delivery Instrument will not

work eciently and clog if used without the Cannula.

™

5 The Accelerate

Graft Delivery Instrument may

not function as intended (and is likely to clog) if the

autograft content of the nal bone grafting mixture

exceeds 50% of the total volume.

6 Close and open the Cannula once or twice to make

the closing of the Cannula easier once it has been
loaded with bone graft mixture.

7 If the Cannula won’t completely close, redistribute or

remove small amounts of bone grafting mixture until

the Cannula completely closes. Overlling of Cannula

increases the likelihood of clogging.

™

8 Do not force the Cannula into the Accelerate

Funnel.
If you experience resistance loading the Cannula into
the Accelerate™ Funnel, redistribute or remove small
amounts of bone grafting mixture.

™

9 The Accelerate

Instrument Set contains two
Accelerate™ Funnels for simultaneous preloading
of Cannulas with bone graft mixture.

™

10 If the Cannula (inside of the Accelerate

Funnel) is
hitting the Body and preventing the Accelerate™
Funnel from properly engaging, ensure the Cannula
is fully seated.

11 The proximal tip of the Cannula should be aligned

with the Plunger.

12 It may take several Trigger squeezes prior to

delivery of the bone graft mixture. Typically, the

bone graft mixture in the Cannula rst compresses,
and then begins to ow through distal end of the

™

Accelerate

Funnel.

13 If there is increasing resistance/diculty in squeezing

™

the Trigger, remove the Accelerate

Graft Delivery
Instrument from the surgical site and disassemble in
accordance with the instructions in the Reloading and
Disassembly section of this User Guide.

14 If the Plunger is hard to pull back, conrm that the

Trigger has been fully reset, and sits ush with the

™

Accelerate

Body.

15 The Cannula is intended for SINGLE USE ONLY. If

additional bone graft is needed, repeat the loading
process with a new Cannula until the desired amount
of bone graft mixture is delivered.

16 If the Cannula is dicult to remove, simultaneously

™

twist the Accelerate

Funnel while pulling out the

Cannula.

17 For rapid bone graft delivery, it is recommended that

™

the spare Accelerate

Funnel is prepped and loaded
with a Cannula to allow for rapid Accelerate™ Funnel
exchange.

18 Be sure to remove the Cannula after use (and prior

to sterilization).

ACCELERATE

PROCEDURE

™

BONE GRAFT DELIVERY SYSTEM

Graft Preparation

Autograft Preparation

Mill (or mince) the autologous bone until the graft pieces

are less than 3.2mm in diameter. The specied sizes can

be obtained using Medtronic Bone Mill (Midas Rex™ Bone
Mill, Figure 1). If using a Stryker Bone Mill, only the Fine
Blade can mill to the required bone chip sizes.

Note

The instrument will clog if the bone chip size exceeds

3.2mm in diameter.

Note

Use Accelerate™ Graft Delivery Instrument as intended
only with Grafton™ DBF. Use with other products

(mineralized allograft, synthetics, dierent bone

graft formulations, etc.) will likely result in decreased
performance, clogging, and possible permanent
malfunction.

Grafton™ DBF Preparation

Hydrate the Grafton™ DBF with blood, bone marrow
aspirate, sterile saline, or sterile water in accordance
with the Instructions For Use (IFU).

Note

Only use Accelerate™ BG Set T502XX Grafton™ DBF. The
original T501XX Grafton™ DBF will not be compatible as it
does not contain the Cannula.

Note

The Accelerate™ Graft Delivery Instrument will not work

eciently and clog if used without the Cannula.

“Bone Graft Mixture” Preparation

Combine the hydrated Grafton™ DBF with up to an equal
volume of autograft (milled to less than 3.2mm in diameter)

(Figure 2). Add additional uid to the bone graft mixture to

obtain the desired consistency.

Note

The Accelerate™ Graft Delivery Device may not function as
intended (and is likely to clog) if the autograft content of the

nal bone grafting mixture exceeds 50% of the total volume.

Figure 2Figure 1

6

ACCELERATE™ BONE GRAFT DELIVERY SYSTEM

PROCEDURE

Filling the Accelerate™ Cannula
with the Bone Graft Mixture

Remove the Cannula from Accelerate™ BG Set T502XX
Grafton™ DBF box using standard aseptic techniques.

Note

Close and open the Cannula once or twice to make the
closing of the Cannula easier once it has been loaded with
bone graft mixture.

Place the Cannula(s) into the grooves on the Accelerate

™

Graft Delivery Loading Platform concave up (Figure 3).
Up to two Cannulas may be placed simultaneously on

Figure 3

the Loading Platform. Spread the bone grafting mixture
uniformly in the Cannula ensuring the bone graft mixture
stays within the top of the Cannula curvature (Figure 4). After

the Cannula is lled, close the Cannula (Figure 5).

Note

If the Cannula won’t completely close, redistribute or
remove small amounts of bone grafting mixture until the

Cannula completely closes. Overlling of Cannula increases

the likelihood of clogging.

Figure 4

Figure 5

7

ACCELERATE™ BONE GRAFT DELIVERY SYSTEM

PROCEDURE

Loading the Accelerate™ Cannula

™

into the Accelerate

Funnel

Insert the lled Cannula into the proximal end of
Accelerate™ Funnel (Figure 6).

Note

Do not force the Cannula into the Accelerate™ Funnel. If
you experience resistance loading the Cannula into the
Accelerate™ Funnel, redistribute or remove small amounts
of bone grafting mixture.

When properly inserted, the Cannula will protrude
approximately 5mm from the proximal end of the
Accelerate™ Funnel (Figure 7). An internal ledge prevents
the Cannula from sliding out of the distal end of the
Accelerate™ Funnel.

Note

The Accelerate™ Instrument Set contains two
Accelerate™ Funnels for simultaneous preloading
of bone graft mixture.

Figure 6

Cannula protrudes 5mmFigure 7

8

ACCELERATE™ BONE GRAFT DELIVERY SYSTEM

PROCEDURE

Attaching the Accelerate™ Funnel

™

to the Accelerate

Body

Slide the Accelerate™ Funnel Pin into the Body Socket at a
perpendicular angle (Figure 8). While depressing the Clasp
on the Body (Figure 9), rotate the Accelerate™ Funnel into
alignment with the Accelerate™ Body (Figure 10). Once the
Accelerate™ Funnel and Body are aligned, release the Clasp
and ensure the Accelerate™ Funnel is securely attached to
the Body.

Note

If the Cannula (inside of the Accelerate™ Funnel) is hitting the
Body and preventing the Accelerate™ Funnel from properly
engaging, ensure the Cannula is fully seated (Figure 11).

Note

The proximal tip of the Cannula should be aligned with
the Plunger.

Advance the Plunger into the Accelerate™ Funnel by
squeezing the Trigger (approximately 2-3 times). The
positive engagement of the Plunger into the Cannula will
improve the overall stability of the Instrument.

Figure 8

Figure 10

Funnel Pin

9

Figure 11

Figure 9

Cannula protrudes 5mm

ACCELERATE

PROCEDURE

™

BONE GRAFT DELIVERY SYSTEM

Delivery of the Bone Graft Mixture

Squeeze the Trigger to begin delivery of the bone graft
mixture to the surgical site. The Plunger will advance the
bone graft mixture with each Trigger squeeze until the
Cannula is empty (Figure 12).

Note

It may take several Trigger squeezes prior to delivery of
the bone graft mixture. Typically, the bone graft mixture

in the Cannula rst compresses, and then begins to ow

through distal end of the Accelerate™ Funnel.

The bone graft mixture should ow easily with each
Trigger squeeze.

Note

If there is increasing resistance/diculty in squeezing the

Trigger, remove the Accelerate™ Graft Delivery Instrument
from the surgical site and disassemble it in accordance with
the instructions in the Reloading and Disassembly section of
this User Guide.

Figure 12

10

ACCELERATE™ BONE GRAFT DELIVERY SYSTEM

PROCEDURE

Reloading and Disassembly

To remove the Plunger from the Accelerate™ Funnel,
simultaneously grasp the Back Handle (do not squeeze
the Trigger) and depress the grey Plunger Release
Tab with one hand. While depressing the Release Tab,
completely pull the Plunger out of the Accelerate™ Funnel
with the other hand (Figure 13).

Next, remove the Accelerate™ Funnel by depressing
the Clasp with one hand, and rotating it perpendicular
to the Body with the other hand (Figure 14). Disengage
the Accelerate™ Funnel from the Body, then remove the
Cannula from the Accelerate™ Funnel and discard the
Cannula (Figure 15).

Note

If the Plunger is hard to pull back, conrm that the
Trigger has been fully reset, and sits ush with the

Accelerate™ Body.

Note

The Cannula is intended for SINGLE USE ONLY. If additional
bone graft is needed, repeat the loading process with a new
Cannula until the desired amount of bone graft mixture is
delivered.

Note

If the Cannula is dicult to remove, simultaneously twist
the Accelerate™ Funnel while pulling out the Cannula.

Note

For rapid bone graft delivery, it is recommended that the
spare Accelerate™ Funnel is prepped and loaded with a
Cannula to allow for rapid Accelerate™ Funnel exchange.

Note

Be sure to remove the Cannula after use (and prior
to sterilization).

Figure 13 Figure 14

Figure 15

11

ACCELERATE™ BONE GRAFT DELIVERY SYSTEM

PROCEDURE

Graft Recovery

If a jam occurs, there are provisions to recover the clogged
bone graft. First, remove the Accelerate™ Graft Delivery
Instrument from the surgical site. Follow the disassembly
instructions as outlined in the previous Reloading and
Disassembly section to remove the Accelerate™ Funnel
from the Body.

Attach the proximal end of the Accelerate™ Funnel to
the top of the Graft Recovery Platform (Figure 16). Then,
insert the Graft Recovery Tool into the distal tip of the
Accelerate™ Funnel (Figure 17). To push the Cannula out of
the Accelerate™ Funnel, gently mallet the Graft Recovery
Tool into the Accelerate™ Funnel (Figure 18). The Cannula

may bend and or collapse as it is malleted from the
Accelerate™ Funnel (Figure 19). Recover bone graft mixture
by gently opening the Cannula.

The recovered bone graft mixture may be delivered with the
Standard Bone Funnel included in the set. The Graft Recovery
Tool will act as the bone tamp for this backup graft delivery
method (Figure 20).

Figure 16

Figure 18 Figure 19 Figure 20

12

Figure 17

PRODUCT ORDERING

INFORMATION

Instrument Ordering Information

Accelerate™ Graft Delivery Instrument Set

SPS02688

Part Number Description User Guide Description

6061006 Graft Delivery Funnel Accelerate™ Funnel (Qty 2)

6061007 Graft Gun Accelerate™ Body

6061020 Graft Loading Platform Accelerate™ Graft Delivery Loading Platform

6061023 Graft Recovery Tool Accelerate™ Graft Recovery Tool

6061024 Recovery Platform Accelerate™ Recovery Platform

2940171 Bone Funnel Standard Bone Funnel



Implant (Bone Graft) Ordering Information

Accelerate™ Grafton™ DBF with Cannulas

Part Number Description

T50203 Accelerate

™

BG Set T50203 Grafton™ DBF 3cc 2

Number of Cannulas

T50206 Accelerate™ BG Set T50206 Grafton™ DBF 6cc 2

T50209 Accelerate™ BG Set T50209 Grafton™ DBF 9cc 4

T50212 Accelerate™ BG Set T50212 Grafton™ DBF 12cc 4

Accessory Ordering Information

Midas Rex™ Bone Mill

Part Number SAP Description

BM110 Midas Rex™ Bone Mill Base

BM120 Midas Rex™ Bone Mill Console

BM130 Midas Rex™ Bone Mill Instrument

BM210 Midas Rex™ Dual Blade Disposable

EA600 Power Cord, US



13

IMPORTANT PRODUCT

INFORMATION

Accelerate™ Bone Graft
Delivery System

Intended Use

These orthopedic manual surgical instruments are
intended for use in surgical procedures to manipulate
tissue, bone, or for use with other devices in orthopedic
surgery. An instrument may incorporate a measuring
function which has uses as described on the label and the
instrument.

DO NOT IMPLANT THE INSTRUMENTS.

MEDTRONIC does not and cannot warrant the use
of this instrument nor any of the 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 tness for a particular purpose or use
are specically excluded.

Risks

Breakage, slippage, misuse, or mishandling of
instruments, such as on sharp edges, may cause injury
to the patient or operative personnel. It is important that
the surgeon exercise extreme caution when working in
close proximity to vital organs, nerves or vessels, and that
the forces applied while correcting the position of the
instrumentation is not excessive, such that it might cause
injury to the patient.

For a complete list of indications, safety, and warnings for
Accelerate™ Graft Delivery Instrument Set, please visit

https://manuals.medtronic.com/content/dam/emanuals/
spinal/0380035E_MDT_Reusable_Instruments_and_
Accessories_eManual_revG.pdf

For more information visit Medtronic.com or
call [phone].

Grafton™ DBF

Indications

Grafton™ DBF can be used in orthopedic or reconstructive
bone grafting procedures. The product can also be used
in bone grafting procedures in combination with
autologous bone or other forms of allograft bone, or
alone as a bone graft.

Contraindications

The presence of infection at the transplantation site is a
contraindication for the use of this allograft.

Caution

This allograft may contain trace amounts of antibiotics
(gentamicin), antiseptic (povidone-iodine) and alcohol
solutions. Caution should be exercised if the patient is
allergic to these antibiotics or chemicals.

Precautions

Extensive donor blood serum testing, medical and social
history screening procedures, and tissue microbiological

testing were used in the qualication of tissue donors.

Despite the viral inactivation and extensive tissue donor

selection and qualication processes used in providing

this tissue graft (see DONOR SCREENING AND TESTING),
transmission of a communicable disease is still possible.
Bacterial infection at the graft site may also occur. Adverse
outcomes potentially attributable to

Grafton™ DBF must be reported promptly to Medtronic.
If injecting Grafton™ DBF into the defect site, precaution
should be taken not to:

 over-pressurize the delivery device, as this may lead to

extrusion of the device beyond the site of its intended
application and damage to the surrounding tissues.

 over-pressurize the defect site, as this may lead to fat

embolization or embolization of the device material into
the bloodstream.

For a complete list of indications, safety, and warnings
for Grafton™ DBF, please visit https://manuals.

medtronic.com/content/dam/emanuals/spinal/
M708348B464EGraftonDBFDemineralizedBoneMatrix
DBMFibersRevD.pdf

For more information visit Medtronic.com or
call [phone].

14

ACCELERATE™ BONE GRAFT DELIVERY SYSTEM

IMPORTANT PRODUCT INFORMATION

Midas Rex™ Bone Mill

Indications

The Midas Rex™ Electric Bone Mill is intended to mill bone, producing bone particles 1 to 5 mm in size.

The bone mill is not restricted to a specic patient population.

Intended Use

The intended target populations include adult and pediatric patients.

Contraindications

There are no known contraindications.

For a complete list of indications, safety, and warnings for Midas Rex™ Bone Mill, please visit https://

manuals.medtronic.com/content/dam/emanuals/st/M333083W001DOC1REVAFINAL.pdf

For more information visit Medtronic.com or call [phone].

15

Medtronic
Spinal and Biologics Business
Worldwide Headquarters

2600 Sofamor Danek Drive
Memphis, TN 38132

The Use r Guide shown i s for illustr ative
purposes only. The technique(s) actually
empl oyed in each case w ill always
depend upon the medical judgment
of the su rgeon exercised b efore and
duri ng surgery as to t he best mod e of

treatm ent for eachpat ient.

Consul t instruc tions for use at t his
website www.medtronic.com/
manuals.

Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132

[phone]
[phone]
Customer Service: [phone]

medtronic.com

Please s ee the packag e insert for t he
compl ete list of indi cations, wa rnings,
precautions, and other impor tant
medical information.

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