KLSCMFTiMAND.X Fix External Fixator

7/25/2019 KLSCMFTiMAND.X Fix External Fixator

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Craniomaxillofacial Surgery

The modern version of a mandibular xation classic

A Rigid External Fixation System

Xternal Fixator


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Xternal Fixator

Indications

The KLS MartinTitanium Xternal Fixator is intended to stabilize and provide treatment

for fractures of the maxillofacial area, including:

mandible fractures

mandible fractures associated with infection

severely comminuted mandible fractures

non-unions

tumor resections

gunshot wounds

The KLS MartinXternal Fixator System

The KLS MartinXternal Fixator can be assembled in two unique configurations.

fractures with severe soft tissue compromise

fractures in irradiated patients

panfacial fractures

burn maintenance

Features

MRI safe construct

Adjustable throughout application


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51-672-05

51-672-04

51-672-03

51-672-01

51-672-02

Set Overview

- Configuration 1

The KLS Martin Titanium Xternal Fixator creates a rigidconstruct using three basic components: 4.0 mm rods, 4.0 mmfixation screws with 2.7 mm threads , and snap-on, adjustableclamps.

Implants

Adjustable Clamp

Accepts the 3.2 mm fixation pin and the 4.0 mm

rod on each end of the clamp.

Snap-on design allows additional clamps to be

placed.

Connects two rods in any orientation.

Maintains the rod position during frame assembly

and fracture reduction.

4.0 mm Titanium Fixation Pin with 2.7 mm thread

Strong, stable fixation.

Biocompatible titanium alloy.

Four thread lengths (7, 9, 13 and 17 mm)

accommodate various soft tissue and bone

thicknesses.

note: Included with the titanium fixation pins is a latex-free tipgua rd. Thi s ti p guard is autoclavab le and all ows the surgeo n to cover

the end of the pin providing a smooth surface.

4.0 mm Titanium Pre-Bent Rods

Rods pre-bent to shape of mandible.

Available in 6 sizes.

Can be contoured to match patient anatomy.

51-670-04for use with51-670-07-11

1:1

1:1

1:2

51-673-07

51-673-09

51-673-13

51-673-17

51-672-06

51-672-07

clamp

pins


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Xternal Fixator

Screwdriver BladX-Fix, 2.0 mm/BO

Instruments-not to scale-

Rod Template

Facilitates

contouring

the pre-bent

titanium rods.

51-671-28

Rod Bender

For contouring pre-bent

titanium rods.

50-125-16

Drill Guide/Cannula, long

To protect soft tissue during

insertion of pins or Kirschner

wires.

50-501-29 50-501-19

Depth Gauge

50-501-40

Trocar Handle

50-501-01

Cheek Retractor

50-501-10

51-600-70

Screw CapScrewdriverTwist Drill

50-022-15

25-410-00

Ratchet StyleScrewdriver Handle

51-600-86

Trocar/Cannula, short

50-501-09


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Surgical Technique

1 Place the patient in maxillomandibular fixation whenappropriate.

2 Identify the appropriate rod or combination of rods forfixation. In most cases, the pre-bent rods will not need

additional contouring. If contouring is needed, follow steps

34, otherwise skip to step 5.Note: If rod needs to be cut, use a large pin cutter. Ensure rod is removed

from patient prior to cutting.

Caution: Ensure that both pieces of the bar are held during bending process.

3 Contour the Rod Template (51-671-28) on thepatient to match the patients bony anatomy.

Note: Rod should be positioned at least one centimeter from soft tissues.

4 Using the bender, contour the selected pre-bent rod tomatch the rod template.

5 Verify the fit of the pre-bent rod on the patient. Identifythe desired pin locations for the first and last pin (furthestfrom the defect on the proximal and distal side) and mark

accordingly. A minimum of two pins per segment (two

pins in greatest segment and two in other segments) is

recommended to ensure adequate stability. Optimal location

of pins will place one pin a minimum of 10 mm proximal to

the defect.

6 To insert a pin, make a small incision and dissect thesoft tissue at the first marked pin location.

3

2

4


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Xternal Fixator

Surgical Technique (continued)

7 Insert the cannula (50-501-19) into the trocar handle(50-501-01). Insert the 4.0 mm trocar (50-501-09)into the

handle/cannula assembly. Pass the trocar through the stab

incision to the bone. Remove the trocar.

8 Use the 2.2 mm twist drill (50-022-15) through thecannula to drill into the bone. Remove drill guide. If using a

self-drilling pin, load approximately 5 mm of the pin

directly into a Jacobs chuck drill. Using the cannula as a

guide, drive the fixation pin into the mandible, stopping when

the collar on the pin is against the buccal cortex.

9 Insert the depth gauge (50-501-40) through thecannula and hook the lingual cortex of the mandible.

Removethe measuring device from the cannula. Insert the

X-Fix pin into the Ratchet Driver (25-410-00) with Triangle

Blade (51-600-86). Ensure ratchet handle is in the forwardposition.

10 Select the X-Fix pin with the appropriate length thread.

With clockwise rotation, insert the X-Fix pin through the

cannula until the stop is seated against the buccal cortex,

ensuring proper implant depth.

10A

10B

7

8

9


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Surgical Technique(continued)

11 Following steps 610, position and insert the secondpin on the opposite side and furthest from the defect.

12 Snap bar clamp (51-670-05) onto both X-Fix pinsand rod.

13 Reduce the fracture in standard fashion andtighten the clamp nuts.

14 Verify the correct alignment prior to proceeding.

7

12A

12B

13

14

11


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Xternal Fixator

Surgical Technique(continued)

15 Attach a third clamp to the rod approximately 10 mmproximal or distal to the defect in the stable bone segment.

16 Select the appropriate length cannula, based on softtissue thickness, and insert the cannula into the clamp as

shown. Angle the cannula and clamp for the desired pin

placement. Mark the incision site. Temporarily rotate the

cannula and clamp upwards to minimize obstruction while

making the incision. Make a small incision and bluntly dissect

the soft tissue. Rotate the clamp and cannula to the original

position. Insert the trocar and pass the cannula through the

incision to the bone. Remove the trocar. Tighten the clamp,

securing the cannula to the rod.

Note: Do not overtighten the clamp as this will result in damage to

the cannula.

17 Insert a pin as outlined in steps 816. Loosen theclamp slightly and slide the cannula off of the X-Fix pin. With

the clamp capturing the pin and the rod, tighten the clamp

nut.

18 Insert all remaining pins to complete the frame, asoutlined in previous steps.

Note: A minimum of two pins are required on each side of the

defect.

19 Verify reduction and alignment. If adjustment isneeded, loosen the clamp nuts, manipulate the mandible,

and retighten the clamps.

20 Place tip guards, if desired, to prevent pins fromcatching on skin and clothing.

16

17A

19

18

17B


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9

Alternative Frame Configuration

One-half frame

- as applied on an infected angle fracture

Modular frame

- as applied on a comminuted fracture. A modular

frame can be created depending on fracture location.


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Xternal Fixator

he KLS MartinXternal Fixator is an easy-to-use system for mandibularfractures and defects with minimal incisions.

- Configuration 2

System benefi ts:

Easy to apply

Self-drilling pins

Titanium pins and washers

3 different thread lengths of 7 mm,

11 mm, and 13 mm

he KLS MartinMandibular Xternal Fixator is intended to

stabilize fractures and defects including:

mandible fractures

mandible fractures associated with infection

severely comminuted mandible fractures

non-unions

tumor resections

gunshot wounds

fractures with severe soft tissue

compromise

fractures in irradiated patients

panfacial fractures

burn maintenance

bone grafting defects

Lower cost fixation option

Limited internal hardware

Extremely stable 3.2 mm pin


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Instruments- not to scale

1

X-Fix Screw Cap

51-670-01

X-Fix Carbon Fiber Rod

51-601-03 100 mm, 4 mm dia

X-Fix Carbon Fiber Rod

51-601-07 150 mm, 4 mm dia

Tray for X-Fix, w/Lid

55-969-45 30 cm X 45 cm

Twist Drill

50-022-15

115 mm, 2.2 mm dia,

w/notch, Level I System

51-670-07

X-Fix Connection Bar

51-670-02

Screwdriver,X-Fix Standard

51-600-65

Screwdriver,X-Fix Screw Cap

51-600-70

X-Fix Acrylic Mold

51-671-27

Twist Drill

50-126-06

105 mm, 2.5 mm dia,

w/notch

51-670-11

X-Fix Pins

51-670-13


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Xternal Fixator

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Surgical Technique

1 Depending on the size of the fracture or defect, theappropriate number of pins (51-670-07, 51-670-11, 51-670-

13) can be placed on either side of the unreduced fracture.

A minimum of 2 per side is required. Using the 2.5 mm twist

drill, create a pilot hole for the X-Fix pins. The trocar and drill

guide can be used to place the pins. Use the pin driver to

screw the pins into the bone.

2 Place one X-Fix Connection Bar (51-670-02) on eitherside of the fracture. Tighten with Hex Head Driver (51-600-

65).

WARNING: X-Fix Connection Bars are manufactured from stainless

steel. They must be removed prior to MR Imaging.

3 Place the carbon rod in X-Fix connection bar on oneside of fracture and tighten in place. Reduce fracture and

tighten carbon bar in place on opposite side of fracture. This

creates a stable reduction.

4 The correct size for the acrylic splint is determined byanatomy and fractures. Once determined, the X-Fix AcrylicMold (51-671-27) is adjusted to the appropriate size. Pour

the acrylic mixture in the mold.

-See additional instructions for acrylic mixing on page 14.

-If using plastic tube instead of molding tray see instructions

on page 14.


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5 Using the X-Fix Screw Cap Screwdriver, (51-600-70)place one Screw Cap (51-670-01) on the threaded portion of

each pin. The flat side should be showing.

6 The acrylic can be removed from the tray when it is aputty-like consistency. The acrylic is placed over the pin

threads against the screw washer. Do notplace the outer

screw cap immediately; this may weaken the acrylic bar.

Place the screwcaps only when acrylic has hardened.

7 Using the X-Fix Screw Cap Screwdriver (51-600-70)tighten an additional screw cap against the acrylic. Once the

acrylic has hardened, the carbon bar and connection bar can

be removed.

8 Place tip guard, if desired, to prevent pins from catchingon skin and clothing.

5

6

7


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Xternal Fixator

The Acrylic Splint:

There are two techniques to make acrylic splints; using either the molding tray or a plastic tube.

The tray creates a rectangular shaped acrylic bar with the acrylic exposed to the elements. The secondtechnique uses a plastic tube (endotracheal or chest) placed over the pins and then filled with acrylic.

This technique provides a smoother exterior surface.

Acrylic: An autopolymerizing denture acrylic or orthodontic acrylic can be used to form the bar. The liquid

and powder are mixed according to the manufacturer's specifications. Many of these acrylics are mixed in

a ratio of one cc of liquid to three ccs of powder. It is convenient to have powder and liquid pre-measured

and kept in small individual containers. A bottle holding approximately 8 ccs of liquid and another bottle

holding approximately 24 ccs of powder will create a bar long enough for any single application. Doubling

this amount will make a bar of ample length for any bilateral application.

Acrylic Mixing:

The powder is poured into the liquid in a container of ample size. The creamy mass is stirred

for a minute to insure even mixing. This is allowed to stand for two to three minutes depending on the

temperature of the room. The ideal consistency of the powder/liquid acrylic mixture will depend on the

technique used for bar formation.

Molding Tray Technique: When using the molding tray, the acrylic consistency should be pliable. To prevent sticking,

petroleum jelly can be smeared into the bar-forming tray. The putty-like acrylic mass is placed into a tube

and pressed into the take-apart mold. The acrylic bar is formed into the mold and the excess removed by

hand pressure. Four to five minutes may elapse from the time of mixing until the period of bench curing

has been accomplished.

After approximately 5 minutes, the still pliable plastic bar is carefully removed from the take-apart

mold without deforming its shape.

While still semi-soft, the acrylic bar is pressed onto the machine threads of the bone screws. Care

should be taken to avoid over-thinning the bar. Ensure adequate protrusion of the threaded screw through

the acrylic for placement of the screw caps.

The acrylic bar should be kept away from contact with the skin, as the heat from polymerization

can cause tissue damage. Wet sponges can be placed under the bar to protect the skin.


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STERILIZATION INFORMATION

The KLS MartinXternal Fixator is a non-sterile, single use device.

All titanium, carbon fiber and stainless steel components are steam sterilizable.

STERILIZATION BY USER

The following parameters are recommended:

For pre-vacuum cycles, a 4-minute exposure time at 270F.

Caution: Time required for sterilizer to reach temperature is not included in the times given.

This is based on instructions in Steam Sterilization and Sterility Assurance in Health Care

Facilities (ANSI/AAMI ST46-2002-5.8.1 and 5.8.2.)

Plastic Tube Technique:

When using the plastic tube, the acrylic should be more liquid. The chest tube is cut to length and

fit over the screws. Cut an x through both sides of the tube where the pins will be placed. Cut one holeand place the tube over the pin before the next hole is marked and cut. This process is continued until

all necessary holes are cut. Once all the holes are cut, the tube is placed over the pins to confirm proper

placement.

The acrylic can be placed in the tube in 2 different ways. If the tube is placed over the pins, the

tube can be filled in place using a syringe. Depending on the length of tube, a plastic syringe can be

selected that will hold an adequate amount of acrylic to fill the tube. The tip of the syringe may be trimmed

to facilitate tight placement into the end of the tube. The acrylic is mixed and loaded into the syringe. The

acrylic is then injected into the plastic tube from one end all the way to the other. If the acrylic stiffens or

begins to set, or if the distance is too great to push the acrylic through the entire tube from one end, a

second acrylic mix may be required from the opposite side. Filling the tube from both ends may make

filling the tube easier and faster. If the acrylic is inserted from both ends of the tube, place a small bore

needle into the center of the tube near the mid line to allow any air bubbles to escape. If it is desired to

fill the tube off of the pins, simply remove the tube from the pins and insert the syringe into the tube fillingwith acrylic. Tape can be placed over the pin holes to keep acrylic from seeping out.

The screw caps are placed on the machine-threaded end of the bone screw and initially twisted just

slightly. Final tightening is accomplished when the heat of polymerization has dissipated (approximately

five minutes later). Avoid over tightening the screw caps while the acrylic is soft, as this may thin and

weaken the acrylic bar at these locations.

Once the acrylic is set, the acrylic will return to room temperature. All heat will have dissipated. The

screw caps are securely tightened and the primary or mechanical splint is removed. This is accomplished

by removing it in the reverse order that it was applied.

The rigid, light acrylic bar provides rigid fixation until the fracture site, bone graft, or soft

tissue envelope is healed. When properly placed and maintained, the external fixator can maintain its

biomechanical stability for periods exceeding nine months.


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Xternal Fixator

98-Xterna

v3 1 09 21

P.O. Box 16369 Jacksonville, FL 32245 Tel. 904.641.7746 800.625.1557 Fax 904.641.7378www.klsmartin.com

a member of

Additional Literature

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These extremely accurate stereolithography models

allow for intra-operative use because they are

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Contact us for more information about using

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Selective coloration to aid in

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KLSCMFTiMAND.X Fix External Fixator