Revision 90-01917

Page 1

Universal System

Instruments, Implant Modules and System Containers

Instructions for Use

Page 2

Legend

A

Used to refer to a graphic.

Used for an instructional step that must be performed.

1.

2.

3.

Used for instructional steps that must be performed in

a sequence.

•

Used for unordered list items.

Italic

Used for references and for table or figure titles.

Used to supplement or clarify information.

WARNING

Indicates a hazardous situation that, if not avoided, could result

in death or serious injury.

CAUTION

Indicates a hazardous situation that, if not avoided, could result

in minor or moderate injury.

NOTICE

Indicates information that is considered important, but not

hazard-related, for example messages relating to property

damage.

Page 4

Introduction

1

Introduction

1.1

About this document

This document is the most comprehensive source of information for the safe and effective

use of the product. Read this document carefully and pay special attention to safety

information. Keep this document accessible to users.

1.2

Other applicable documents

In addition to this document, the following documents are available:

●● Reprocessing Guide CMF medical products.

For further information on Stryker’s Electronic Instructions for Use (eIFU), go to

www.ifu.stryker.com. For additional information, contact your Stryker sales representative,

or contact Stryker customer service.

1.3

Disclaimer of liability

In no instance will Stryker be responsible for incidental or consequential damage related to

the product.

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Page 5

Introduction

1.4

Definitions of terms, abbreviations and symbols

The following table provides definitions of terms used in this document.

Definitions of terms

Term

Definition

Cleaning

Removal of contaminants to the extent necessary for further

processing or for the intended use

Disinfection

Process to reduce the number of viable microorganisms to a level

previously specified as being appropriate for a defined purpose.

Healthcare

professional

A healthcare professional is a surgeon, nurse, professional

caregiver, or operating medical staff.

Sterile barrier

system

Minimal packaging that minimizes the risk of ingress of microorganisms and allows the aseptic presentation of the sterile contents

at the point of use.

Sterilization

Process used to render products free from viable microorganisms.

The following table provides definitions of abbreviations used in this document.

Definitions of abbreviations

Abbreviation

Definition

AAMI

Association for the Advancement of Medical Instrumentation

CMF

Craniomaxillofacial

EAK

European waste catalog EAK 180103

EEC

European Economic Community

eIFU

Electronic Instructions for Use

EN

European Standard

EU

European Union

IFU

Instructions for Use

ISO

International Organization for Standardization

US

United States

vCJD

Variant Creutzfeldt-Jakob-Disease

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Introduction

The following table provides the symbols used in this document, on the product, and/or on

the product label.

Definitions of symbols

Symbol

Definition

General warning sign: to signify a general warning.

Manufacturer: indicates the medical device manufacturer.

Date of manufacture: indicates the date when the medical device was

manufactured.

LOT

Batch code: indicates the manufacturer’s batch code so that the batch

or lot can be identified.

REF

Catalog number: indicates the manufacturer’s catalog number so that

the medical device can be identified.

NON

STERILE

Non-Sterile: indicates a medical device that has not been subjected to a

sterilization process.

Do not use if package is damaged: indicates a medical device that

should not be used if the package has been damaged or opened.

Consult instructions for use: indicates the need for the user to consult

the instructions for use.

QTY

GTIN

Quantity: indicates the number of medical devices in the packaging.

Global Trade Item Number

Medical Device

Rx Only

Caution: federal law (USA) restricts this device to sale by or on the order

of a physician.

Conformity assessment according to Annex I of Medical Device

Regulation (EU) 2017/745 without involvement of the notified body.

0197

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Conformity assessment according to Annex I of Medical Device

Regulation (EU) 2017/745 or Medical Device Directive 93/42 EEC with

involvement of the notified body.

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Safety information

2

Safety information

This section presents general product-related safety information and recommendations for

the safe and effective use of the product. For specific safety information, instructions, and

recommendations, refer to each section.

The user and/or patient must report any serious product-related incident to both the manufacturer and the national competent authority where the user and/or patient is established.

Careless handling

WARNING

Careless handling or storage of products may result in loose parts,

lost products, or damage to products. This may significantly reduce

the strength and fatigue resistance of the products or may result in

non-functional products. This may lead to patient harm.

XX Transport products carefully.

XX Protect sensitive areas of the products during transport.

XX Transport contaminated and non-contaminated products separately to prevent cross-contamination.

XX Do not aggressively shake products and ensure that they remain

level during carriage and storage.

Product

modification

Implantation of

a non-implant

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WARNING

Modifying the product may result in product damage. This may lead

to patient harm.

XX Do not modify the product or any accessories except as directed or

intended by the instructions for use.

WARNING

Implantation of materials that are not intended as implants may lead

to patient harm.

XX Ensure all materials that are not specifically intended as implants

(such as parts of the product and accessories) are removed from

the patient prior to surgical completion.

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Safety information

Single-use

products

Damaged

packaging

Contamination

with prions

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WARNING

A single-use product must not be reused as the single-use product is

not designed to perform as intended after the first usage. Changes in

mechanical, physical, or chemical characteristics caused by repeated

use, cleaning, and re-sterilization may compromise the integrity of

the design or material leading to diminished safety, performance, or

compliance with relevant specifications.

XX Refer to the product label and/or the instructions for use to identify single or multiple use as well as reprocessing instructions.

XX Use a single-use product only once.

XX Dispose of a used single-use product properly.

WARNING

Damaged or open packaging, flaws in the sterile barrier system, or an

expired shelf life are indicators of possible product contamination.

XX If a reprocessable product has damaged or open packaging or

flaws in the sterile barrier system, inspect the product.

If the product is not damaged then reprocess the product.

If the product is damaged then dispose of the product.

XX If a non-reprocessable product has damaged or open packaging or

flaws in the sterile barrier system, dispose of the product.

XX If the shelf life of a product is expired, dispose of the product.

WARNING

A product potentially contaminated with prions or other temperature

resistant bloodborne pathogens may lead to cross-contamination by

users to patients.

XX Do not reprocess these products.

XX Dispose of these products by incineration.

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Safety information

Disposal

WARNING

Incorrect disposal of a product may lead to healthcare professional

harm or to environmental damage. A sharp product may cause injuries to the surgical team or to the cleaning team. This may result in

the spread of blood-borne pathogens.

XX Dispose of products in accordance with local regulations such as

the European waste catalog EAK 180103 (Cat. IB, [9, 10]).

XX Pay attention to the sharp edges of products to prevent injuries

and cross-contamination.

XX Dispose of sharp products and empty glass items in a sharps

container.

XX Use specially marked lockable containers and (if applicable)

protection caps.

End of product

life cycle

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WARNING

The end of product life cycle is reached if a product is non-functional,

damaged, corroded, or suspected to be contaminated with prions or

other temperature resistant bloodborne pathogens. The use of such

products may lead to patient harm.

XX Potential contaminated products with prions or other temperature

resistant bloodborne pathogens may not be recycled or reprocessed and must be disposed of.

XX Inspect each product for visible soil, corrosion or other damage as

well as for proper functionality.

XX When the end of the product life cycle has been reached, the

product is unusable. Dispose of the product and contact your

Stryker sales representative or Stryker customer service to ensure

a replacement product is available.

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Product information

3

Product information

This section presents product information of the Stryker Universal System Instruments,

Implant Modules and System Containers.

3.1

Intended use/indications for use

The Stryker Leibinger Universal system is a plate and screw system intended for osteotomy,

stabilization and rigid fixation of fractures and reconstruction.

3.2

Contraindications

The products covered in this document are not the subject to contraindications by themselves. For further details, refer to the instructions for use of the respective implant system.

3.3

Patient target group

The patient target group includes patients identified to undergo a surgical procedure

utilizing the implant system.

3.4

Clinical benefit

The products are used in conjunction with the implant system to support a surgical

procedure.

3.5

User group

These products are intended to be used only by specialized healthcare professionals. The

healthcare professionals must be licensed to perform surgery in the respective field of medicine and must be familiar with the principles of surgical procedure. The healthcare professionals must prepare the products depending on the surgery being performed and must

familiarize themselves with the instructions for use in order to ensure the proper operation

and reprocessing of this product.

The healthcare professional performing any procedure is responsible for determining the

appropriateness of using the product and the specific techniques to utilize for each patient.

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Product information

3.6

Adverse effects

The products covered by this document are not subject of adverse effects by themselves. For

further details, refer to the implant’s instructions for use.

3.7

For use with

Stryker Universal System products are designed to be used together.

WARNING

The use of products from other manufacturers along with a Stryker product may involve

incalculable risks and/or contamination of the product material and misalignments of products. This may lead to patient and healthcare professional harm.

XX Do not use products from other manufacturers along with a Stryker product.

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Usage instructions

4

Usage instructions

This section provides step by step instructions as well as safety information and

recommendations for the safe and effective use of the product during surgery.

Before use

All instruments should be verified for proper function before each clinical use. The user

must be familiar with the instrument function before clinical application. Stryker recommends the use of silicon free, non-mineral oil based lubricant for maintenance of articulated

instruments

4.1

Plate/screw forceps

These forceps function as self-retaining forceps when the prongs are placed in the holes of

the plate. They also allow holding of the plate in place while drilling to place the first screw.

4.2

Bender/cutter

WARNING

Excessively aggressive use of bending instruments may cause recognizable macroscopic

damage to the implant (indentations, elongated screw holes, etc). Deformed plate holes signify not only an increased risk of breakage in these areas but also impair the accurate fit of

the screw head to the plate.

Titanium hardness increases and ductility (bendability) decreases due to cold working during the bending process. This may lead to product failures such as postoperative plate fractures and therefore may lead to patient harm.

XX Ensure that the desired shape of the implant is reached in as few bends as possible.

XX Avoid excessive bending.

XX Avoid acute angles together with small bending radii.

XX Straight plates may not be used and contoured for use around the mandibular angle.

XX Plates that have been severely bent and re-bent must be discarded.

XX Plates with visible damages or deformed plate holes must be discarded.

XX Do not use the 3-prong bender with the locking plates.

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Usage instructions

WARNING

Cutting the implant may reduce the stability of the implant. This may lead to product

failure, injury and therefore to patient harm.

XX Only cut the implant if necessary and in a way that adequate strength and fixation for

the intended use is maintained.

XX If the product is damaged then dispose of the product.

A cut bone plate segment intended to be implanted may have sharp edges. Cutting may lead

to the creation of small particles. Both may cause soft tissue injuries or irritations.

XX Deburr the cut segments.

XX Upon cutting a template, wipe the abrasive surface of the template and the cutting instrument clean of potential particles prior to use on the patient or use with the implants.

XX Perform any required modification of the plate away from the surgical site.

XX Prevent generated particles from entering the patient.

Using the plate cutter may cause uncontrolled movement of the cut plate segment. This may

lead to patient harm.

XX Hold the unfixed portion of the plate with the forceps.

CAUTION

XX Hold the plate cutter at the base of the handle to prevent any inadvertent hand pinching

during operation.

4.2.1 Bender/cutter

The bender/cutters are intended to be used with plates from the upper-face, mid-face

and orthognathic modules. The left plate bender, marked with an L , can be used for 90°

bending procedures (refer to Graphic 1).

How to bend the product:

XX The 1.2/1.7 mm malleable, standard, and GSP plates can be bent with the tip of the left

and right plate bender and cutter.

XX For bending of the 1.7 mm locking plates, the plates must be held with the dedicated

pinpocket to prevent damage of the locking tip.

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Usage instructions

Graphic 1: Use for 90° bending function

The right plate bender and cutter can be used to cut all 1.2/1.7 mm plates. The right side

of the plate bender and cutter is equipped with a mechanism to hold the cut portion of the

plate. An arrow shows to the intersection (CUT).

How to cut the product:

XX Hold the plate bender and cutter with the bold-faced “R” (for right) and “L” (for left)

facing upward in the right and left hand respectively.

XX Cut the plate by inserting the plate into the right plate bender and cutter from the left.

Graphic 2: Plate insertion using the cutter

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Usage instructions

4.2.2 3-prong bender

The 3-prong bender is intended to produce an in-plane bend of the 1.2/1.7 mm malleable

and standard plates (refer to Graphic 3). It will produce slight hole deformation in the

plate where the prongs are inserted. Only straight plate segments can be bent with the

3-prong-bender.

Graphic 3: 3-prong bender

The 3-prong bender is not suitable for bending plates with condensed hole spacing

(refer to Graphic 5).

Graphic 4: Non-condensed hole spacing

Graphic 5: Condensed hole spacing

How to use the product:

XX Hold the 3-prong bender at the base of the handle.

WARNING

Incorrectly holding the 3-prong bender may result in inadvertent hand pinching during a

surgery. This may lead to harm to the healthcare professional.

4.2.3 In-situ plate cutter

WARNING

XX When using the in-situ plate cutter hold the unfixed portion of the plate with forceps to

prevent any uncontrolled movement of the cut plate segment.

The in-situ plate cutter can be used for cutting upper-face and mid-face bone plates in-situ.

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Usage instructions

4.3

Depth measuring gauge

The depth measuring gauge is color-coded red and blue for use with 2.0 mm and 2.3 mm

screw of the Stryker Universal Mandible System. The required screw length is indicated

by the position of the white ring with respect to the numbering scale or for the black depth

gauge by the position of the sliding cannula with respect to the numbering scale (refer to

Graphic 6).

Graphic 6: Black depth gauge

All bicortical screw lengths should be verified prior to insertion with the depth gauge.

How to use the product:

1. For choosing the required screw length for plate fixation, the sleeve A of the depth

measuring gauge must be fully inserted into the respective plate hole prior to measuring.

Otherwise, an incorrect screw length will be indicated for this application.

2. The tip B of the depth measuring gauge should be inserted through the pilot hole until it

locates the distal or lingual cortex.

A

B

Graphic 7: Tip and sleeve of the depth

measuring gauge

NOTICE

Using the depth measuring gauge as a lever may result in bending or damaging the sleeve.

XX Do not use the depth measuring gauge as a convenient tool, for example as a lever. Refer

to Graphic 8.

Graphic 8: Misuse of the depth measuring gauge

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Usage instructions

How to disassemble the product:

XX Disassemble the measuring gauge for cleaning and sterilization. Take out the slide C of

the depth measuring gauge by pulling the slide C backwards (refer to Graphic 9).

C

Graphic 9: Disassembly of the depth measuring gauge

C

Graphic 10: Parts of the depth measuring gauge

4.4

Right angle depth gauge

For use with right angle screw driver use the right angle depth gauge.

The tip of the depth gauge should be inserted through the pilot hole until it locates the distal

or lingual cortex. The required screw length can be measured in accordance with the scale

at the tip of the instrument.

4.5

Trocar system

A drill guide D must be used in combination with the trocar handle to prevent premature

drill failure. The only drill bits that do not require a drill guide when working with the trocar handle are the multi-color striped drill bits.

The drill guides and cheek retractor rotate independent of one another.

How to assemble the product:

XX For trocar handles with adjustable cannula, prior to drilling, the lever G of the handle

must be pushed down in the locked position to secure the drill guide. Failure to do so

may result in excessive heat generation and premature drill failure.

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Usage instructions

How to disassemble the product:

XX Open the lever G , rotate the drill guide D counter clockwise and remove. Then slide the

cheek retractor E attachment mechanism away from the trocar handle H and remove

the cheek retractor by pulling the retractor upwards G .

D

E

G

H

F

Graphic 11: Trocar system

4.6

Trocar system with removable cannula

WARNING

The use of the light source when operated at high levels of brightness may cause temperatures capable of causing patient harm.

XX Pay special attention to the temperature of the light source.

A drill guide D must be used in combination with the trocar handle to prevent premature

drill failure. The only drill bits that do not require a drill guide when working with the trocar handle are the multi-color striped drill bits.

The drill guides and cheek retractor rotate independent of one another.

If variable distances are necessary, the cheek retractor can be replaced by a variable

cheek retractor E or a cheek retracting forceps.

How to use the product:

XX Handle the trocar and cannula with care.

●● Trocar and cannula pointed tip might be sharp.

●● Do not use the cannula pointed tip for skin penetration.

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Usage instructions

How to assemble and disassemble the product:

XX For assembly, insert the cannula F into the trocar handle H , slide the locking mechanism back and insert the cannula. When fully inserted, the locking mechanism will

return to its original position and the cannula will be locked in place.

XX For disassembly, reverse the assembly steps.

D

F

E

H

Graphic 12: Disassembly of the trocar system

4.7

Universal drill guide system

The Universal drill guide is used with all locking plates when the transbuccal approach is

not applied.

How to assemble the product:

XX The drill guide I is inserted into the handle J .

I

J

Graphic 13: Universal drill guide system

4.8

Drill guides

Drill guides are usable for trocar system, trocar system with removable cannula and universal drill guide system.

Drill guide for Trocar system with Removable Cannulas has both a red and blue stripe,

allowing it to be used with both the 2.0 & 2.3 mm drill bits.

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Usage instructions

Color-code

Drill guides, drill bits and taps are color-coded according to the screw diameters.

●● Orange is used for 1.7 mm screws only.

●● Red is used for 2.0 mm screws only.

●● Blue is used for 2.3 mm screws only.

4.9

Screwdriver handles and blades

For disinfection, cleaning and sterilization the blade must be removed from the screwdriver

handle.

How to assemble the product:

XX Depress the collar K , put the screwdriver blade L into the handle and release the collar.

Make sure that the blade is properly inserted in by holding the handle and pulling the

screwdriver blade.

How to disassemble the product:

XX Depress the collar to release the screwdriver blade (refer to Graphic 14).

L

K

Graphic 14: Disassembly of the screwdriver handle and blade

Ratchet handle

The ratchet handle functions as a rigid handle and ratching handle depending upon the

switch position:

●● Rigid handle: Switch in middle position

●● Ratchet handle for insertion: Switch in front position (toward the screwdriver blade)

●● Ratchet handle for removal: Switch in rear position (away from the screwdriver blade)

This screwdriver handle must not be used for the fixation of 1.2 mm screws.

Revolving handle

The rigid revolving handle functions as a rigid and revolving handle depending upon the

switch position:

●● Revolving handle: Switch in front position

●● Rigid handle: Switch locked in rear position

This screwdriver handle must not be used for the fixation of 1.2 mm screws.

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Usage instructions

4.10 Plate holding clamp for trocar system

The clamp with color coding gold (for fracture plates) should only be used with unbent gold

fracture plates.

How to use the plate holding clamp for the trocar system:

1. Secure plate onto holding cap located on distal end of clamp. Ensure that plate is secure

by locking clamp tightly.

2. Position clamp in-situ to desired location.

3. Insert trocar cannula into the opening on the top of clamp M .

4. Drill pilot holes and insert screws in a normal fashion.

M

Graphic 15: Plate holding clamp for the trocar system

4.11 Variable cheek retractor

For cleaning and sterilization disassemble the product.

How to disassemble the product:

XX Disassemble the variable cheek retractor (VCR) with a screwdriver by turning the screw

counter clockwise until the cannular clamp loosens and can be pulled off.

Graphic 16: Disassembly of the VCR

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Graphic 17: Pulling off of the VCR

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Usage instructions

4.12 Repositioning pin

This instrument is designed for use to reposition a displaced/loose zygoma or other loose

bone fragments in the craniofacial area. To apply the instrument, a 2.0 mm pilot hole has

to be drilled with the dedicated drill (“repositioning pin twist drill”). The repositioning pin

must then be carefully inserted up to the shoulder ring before repositioning the loose fragments. The bone should then be fixated with implants at the appropriate anatomical locations. The instrument is not to be used as a lever. The instrument is not to be used in the

mandible. In case of misuse, the instrument could break.

4.13 Implant module

All implant modules contain a screw length and diameter measuring field.

How to use the product:

1. The screw should be inserted into the length measuring groove of the screw measuring

field with the screw head pushed flush against the outer surface of the module.

2. The thread length of the screw can be read at the tip of the screw.

How to change the screws length markers:

XX For individually equipped implant modules, the screw markers may be changed with a

round object (for example a screwdriver blade not thicker than 4 mm) by pushing from

below through the implant module N .

N

Graphic 18: Changing of screws markers

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Usage instructions

4.14 Screw disc

The screw discs can be ordered empty and unsterile. The description of the screws loaded

in the disc is printed under the clear lid. A screw measuring scale for confirmation of the

thread length of the screw and the diameter of the screw is located on the corner of the disc.

In case of a contamination of the screw field under the lid, the lid should be removed by

loosening the center screw O with a screwdriver and cleaning the screw field manually

with a brush. Please clean carefully to avoid screw spillage. The lid should be replaced and

retightened carefully to avoid stripping. Any contaminated screws should be disposed of.

Contaminated screws must not be used.

O

Graphic 19: Disassembly of the screw disc

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Reprocessing

5

Reprocessing

●● It is the responsibility of the user facility to make sure that appropriate cleaning and

disinfection methods are used where Stryker recommendations are not followed.

●● New products must be carefully cleaned before initial sterilization. Trained personnel

must perform cleaning (manual and/or machine cleaning, ultrasound treatment, etc.)

along with maintenance and mechanical inspection prior to initial sterilization.

●● Exact compliance with the equipment manufacturers’ user instructions and recommendations for chemical detergents is required. Stryker recommends only the use of neutral

pH cleaning and disinfecting agents.

●● Contamination by non-conventional transmissable agents, e.g. vCJD (variant

Creutzfeldt-Jakob-Disease), in accordance with the system indications for use, in particular through contact with lymphatic tissue, is possible. Stryker recommends to incinerate any product that is suspected to have been contaminated by non-conventional

transmissible agents.

5.1

Decontamination and cleaning process

A. Manual decontamination and cleaning:

1. Preparing the bath

●● Dilute the decontaminating – cleaning detergent in running water according to the

detergent manufacturer’s instructions, preferably at 40 °C (105 °F). Temperature

should not exceed 50 °C (122 °F). Stir the mixture to homogenize the solution.

2. Instruments

●● Handle instruments with care. Do not let them knock against each other.

3. Soaking

●● Soak instruments and containers immediately after use. If a sticky substance remains

on the instrument or container, wipe it with single-use paper soaked in 70 % alcohol.

Using a syringe, aspirate and squirt the soaking solution several times into grooves

and holes in order to push out any substances that might prevent liquid from penetrating through the entire instrument or container. After the preparation phase, immerse the instruments and containers in the decontamination solution. Make sure that

the instrument or container is completely submerged. Soak for 15 minutes.

WARNING

Soaking for more than 15 minutes could cause instruments and containers to corrode.

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Reprocessing

4. Manual cleaning

●● Brush the instrument or container vigorously using an appropriate polishing brush

(see Table 1) to remove any debris present on the device. Pay particular attention to

rough surfaces and features where soil may be shielded from the brushing as well as

cannulations, blind holes, hinges and joints between mating parts.

5. Rinsing instruments and containers

●● Rinse the instrument or container thoroughly in running water until it is no longer

slippery to the touch. Close attention should be paid to this process, since the quality

of the remaining steps depends upon it. Repeat steps III and IV if soil is still visible.

Drain the instrument or container on single-use blotting paper.

6. Moving the instruments to the cleaning area

●● If the ultrasound cleaning area is different from the decontamination area, rinsed instruments and containers must be transported in a closed system, either a covered pan

or a heat-sealed bag. This prevents contamination during transfer.

B. Ultrasound cleaning for instruments:

1. Preparing the ultrasound bath

●● Dilute the decontaminating-cleaning detergent in the ultrasound tank according to the

detergent manufacturer’s instructions at 40 °C (105 °F). Stir the mixture to homogenize

the solution.

2. Instrument handling

●● Handle instruments with care. Do not let them knock together. Avoid mixing instruments and containers in good condition with those whose surfaces are damaged.

3. Soaking and ultrasound action

●● After the decontamination phase, immerse the instruments in the decontaminatingcleaning solution in the ultrasound tank. Make sure that the instruments do not overlap and that the instruments are completely submerged. Cleaning lasts 15 minutes.

When the ultrasound bath solution is renewed, it must be ultrasonically degassed for

5 minutes. After the 15 minutes of ultrasound, brush the instrument vigorously using an appropriate polishing brush (see Table 1) to remove any debris present on the

device.

4. Rinsing the instruments

●● Rinse the instruments thoroughly in sterile purified (European Pharmacopoeia 6th

edition or USP 33) water at ambient temperature. Repeat step III if soil is still visible.

Drain the instruments on single-use blotting paper.

5. Drying

●● Dry the instruments and containers using single-use blotting paper or medical compressed air (European Pharmacopoeia 6th edition or USP 33).

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