Universal System Instruments, Implants and System Containers Instructions for Use

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.

Table of contents

1

Introduction...1 1.1 1.2 1.3 1.4

About this document... 1 Other applicable documents... 1 Disclaimer of liability... 1 Definitions of terms, abbreviations and symbols... 2

2

Safety information...4

3

Product information...7 3.1 3.2 3.3 3.4 3.5 3.6 3.7

4

Intended use/indications for use... 7 Contraindications... 7 Patient target group... 7 Clinical benefit... 7 User group... 7 Adverse effects... 8 For use with... 8

Usage instructions...9 4.1 4.2

Plate/screw forceps... 9 Bender/cutter... 9 4.2.1 Bender/cutter... 10 4.2.2 3-prong bender... 12 4.2.3 In-situ plate cutter... 12 4.3 Depth measuring gauge... 13 4.4 Right angle depth gauge... 14 4.5 Trocar system... 14 4.6 Trocar system with removable cannula... 15 4.7 Universal drill guide system... 16 4.8 Drill guides... 16 4.9 Screwdriver handles and blades... 17 4.10 Plate holding clamp for trocar system... 18 4.11 Variable cheek retractor... 18 4.12 Repositioning pin... 19 4.13 Implant module... 19 4.14 Screw disc... 20

5

Reprocessing...21 5.1 5.2

Decontamination and cleaning process... 21 Sterilization... 28

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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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

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

GTIN

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.

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.

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.

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.

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. 7/29

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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