MODUS OPS1.5 Implant Plates, Screws and Accessories Instructions for Use

Instructions for Use: Medartis MODUS OPS1.5 Implant Plates, Implant Screws, Bending Templates, Instruments and Accessories

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All of the implant components are intended for single use and may not be reused under any circumstances

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Necessary care must be observed for storage and use of the products:  Damages (e.g. from improper cutting or bending) to and/or scratches on the instruments/implants can substantially impair the strength of the product and lead to premature breakage  Repeatedly bending the plate in opposite directions may cause the plate to break during postoperative treatment All of the system components have been developed and manufactured for a specific purpose and are therefore precisely adapted to each other. The user may not alter any of the components or replace them with an instrument or product from another manufacturer even if the size or shape is similar or exactly corresponds to that of the original product. The use of materials from other manufacturers, structural changes resulting from the use of third-party products and/or material impurities, as well as minor deviations or imprecise fit between the implants and instruments, or similar, can represent a risk for the user, patient or third parties The sterilizing cases, instrument trays and implant containers shall not be vigorously shaken or tipped over since the individual components may become damaged or fall out Unless otherwise expressly stated on the label, the instruments can be reused Twist drills: It is recommended not to exceed a maximum drilling speed of 1’000 revolutions per minute to avoid overheating the bone. Twist drills may only be used for a maximum of ten times Use the indicated screwdriver for the respective system size. Make sure that the screwdriver/screw head connection is precisely vertically aligned. If not, there is a greater risk of damage to the implant and screwdriver blade. When inserting the screw, ensure that a sufficient axial force is used between blade and screw. At the same time, the axial force should be in certain limits in order not to damage the bone structure

Introduction These instructions for use are for a product line of Medartis AG, Hochbergerstrasse 60E, 4057 Basel/Switzerland Phone +41 61 633 34 34, Fax +41 61 633 34 00, www.medartis.com. All instructions provided in this document must be followed.

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Notes Regarding the Delivered Goods The individual parts of the system may only be accepted when the manufacturer’s label and packaging are undamaged and unopened at the time of delivery. If this is not the case, the rejected goods must be returned to Medartis AG, Basel/Switzerland or to the relevant Medartis Territory Consultant or distribution partner within ten working days. Implants are intended for single use only and are not designed to be reused. All components are delivered NON-STERILE and must be appropriately prepared before first use. All packaging must be removed before preparation.

Product Materials All MODUS implants are made of pure titanium (ASTM F67, ISO 5832-2) or titanium alloy (ASTM F136, ISO 5832-3). All of the titanium materials used are biocompatible, corrosionresistant, and non-toxic in a biological environment. The instruments are made of stainless steel, PEEK, aluminum or titanium.

Color Coding Concept The MODUS OPS 1.5 system is color coded according to system sizes (instruments) and function (plates): System MODUS OPS 1.5

Color Code green

The implant plates of the MODUS OPS 1.5 system are color coded in blue which stands for "malleable".

Intended Use MODUS OPS 1.5 screws and plates The MODUS system is intended for osteotomies and fractures in the craniofacial region which demand positional and functional stability.

Indications Reconstruction and fixation of orbital floor and orbital wall fractures (ideally for fracture sizes > 1.5 cm2) [according to C. Jaquiéry et al.1] MODUS implant plates M-4440 and M-4442: Category 1: Isolated defects of the orbital floor or the medial wall, 1 – 2 cm2 Category 2: Defects of the orbital floor and/or medial wall > 2 cm2 (bony ledge preserved at the medial margin of the infraorbital fissure) MODUS implant plates M-4444 and M-4446: Category 2: Defect of the orbital floor and/or medial wall > 2 cm2 (bony ledge preserved at the medial margin of the infraorbital fissure) Category 3: Defect of the orbital floor and/or medial wall > 2 cm2 (missing bony ledge medial to the infraorbital fissure) Category 4: Defect of the entire orbital floor and the medial wall, extending into the posterior third (missing bony ledge medial to the infraorbital fissure) 1

C. Jaquiéry Reconstruction of orbital wall defects: critical review of 72 patients Classification of orbital wall defects, Int J Oral Maxillofac Surg. 2007 Mar; 36(3):193-9

Contraindications     

Pre-existing or suspected infection at or near the implantation site Known allergies and/or hypersensitivity to foreign bodies Inferior or insufficient bone quality to securely anchor the implant Patients who are incapacitated and/or uncooperative during the treatment phase The treatment of at-risk groups is inadvisable

Possible Complications In most cases, potential complications have a clinical source as opposed to arising from the implants/instruments. These include among other things:  Screw loosening through insufficient fixation  Hypersensitivity to metal or allergic reactions  Bone necrosis, osteoporosis, insufficient revascularization, bone resorption and poor bone formation that can cause premature loss of fixation  Soft tissue irritation and/or nerve damage through surgical trauma  Early or late infection, both superficial and deep  Elevated fibrotic tissue reaction around the surgical area  Malpositioned plate, with the development of postoperative enophthalmos, hypoglobe and diplopia  Entrapment of tissue with limited ocular motility  Subsequent bleeding with retrobulbar hematoma and optic nerve compression

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Instructions for Selecting the Appropriate MODUS Products Medartis, as manufacturer, does not recommend a specific surgical procedure for a specific patient. The operating surgeon is solely responsible for choosing the appropriate implant for the specific case. The follow-up treatment as well as the decision of whether to retain or explant the implant is the responsibility of the user. The treating physician should beforehand become thoroughly familiarized with the procedure, for example by:  Carefully studying all the product documentation  Carefully reviewing the current professional literature  Consulting with colleagues experienced in this field and with the use of this system  Practice in handling the system and practice of the surgical procedure

Additional Information Additional information on the products (e.g. the surgical technique, care, cleaning, disinfection and sterilization) can be requested from your local Medartis Territory Consultant or distribution partner. In addition, all relevant information can be found on the internet at .www.medartis.com.

Instructions Regarding Cleaning, Disinfection and Sterilization All implants, instruments and containers in the MODUS systems are NON-STERILE when delivered and must be cleaned, disinfected and sterilized before each use. This also applies to the first use after delivery (after removal of the protective transport packaging). Thorough cleaning and disinfection are essential for effective sterilization. Implants that were used in a patient and removed, have to be discarded. They are not allowed to be reprocessed. Implants that have come in direct contact with blood or other bodily fluids or show visual contamination must be cleaned and disinfected separately before they can be placed back into the implant tray. It is your responsibility to ensure that the implants and instruments are completely sterile when used, to use device- and product-specific procedures for cleaning/disinfection and sterilization that are sufficiently validated, to regularly service and inspect the employed devices (disinfector, sterilizer), and to ensure that the validated and/or manufacturer's recommended parameters are maintained for each cycle. The statutory regulations applicable in your country and the hospital's hygiene requirements must also be observed. This applies in particular to the various instructions for effectively deactivating prions.

Basic Instructions If possible, use an automated procedure (disinfector) for cleaning and disinfecting. Do not use a manual procedure - even with an ultrasonic bath - due to the significantly reduced efficiency and potential damage. Pretreatment is required in both cases. Choosing Detergents, Disinfectants and Equipment Observe the following aspects when choosing detergents, disinfectants and equipment for all steps:  They must be suitable for their intended use (e.g. cleaning, disinfection or ultrasonic cleaning)  The detergents and disinfectants must be aldehyde-free (otherwise blood residues may dry and attach firmly to surfaces)  The disinfectant used must have a proven effectiveness (such as approval by VAH/DGHM or the FDA, or a CE mark)  The detergents and disinfectants must be suitable and compatible for use with the products  The manufacturers’ instructions, such as those regarding concentration, exposure time and temperature, must be followed For cleaning materials and accessories, both for precleaning and manual cleaning, observe the following  Use only clean, lint-free cloths and/or soft brushes (never use metal brushes or steel wool)  When necessary, use materials and accessories such as cleaning stylets, syringes, cannulas and bottle brushes for cannulated products or products with a lumen

Warnings and Precautionary Measures

For drying accessories, Medartis recommends lint-free disposable paper wipes or medical compressed air.

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For water quality, Medartis recommends that demineralized and purified water (e.g. Aqua purificata) is used for cleaning, disinfection and subsequent rinsing steps.

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The products may only be used by medical personnel who hold relevant qualifications Medartis, as manufacturer, recommends that the user reads all available documents before first use and contacts other users who have practical experience with this type of treatment Never use products that have been damaged by transport, improper handling in the hospital, or in any other way!

Medartis instrument trays (steel or plastic) and implant trays made from aluminum or plastic are intended for the sterilization, transportation and storage of products. They are not intended for

MIDFACE-00000101_Rev. F 2015/10/02 Instructions for Use: Medartis MODUS OPS1.5 implant plates, implant screws, plate formers, instruments, and accessories Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG, 4057 Basel/Switzerland

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