MODUS CFS 1.8 GRID Plates, Screws and Instruments Instructions for Use

Instructions for Use for Medartis MODUS CFS 1.8 Grid Plate, Screws and Instruments 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.

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 branch 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

Color Coding Concept Color Code red green

Intended Use The MODUS CFS 1.8 Condylar Head Fracture System permits a functionally stable, low risk and atraumatic osteosynthesis procedure for the reconstruction of displaced or dislocated fractures of the condylar head using a retro- or preauricular approach.

Indications The MODUS CFS 1.8 Condylar Head Fracture System is used for the stabilization of diacapitular/intracapsular condylar neck fractures with both intra-articular and extra-articular fracture line [according to Neff et al.1]: Type : – Diacapitular/intracapsular fracture with sagittal fracture line (medial pole), with no loss in vertical height Type B – Diacapitular/intracapsular fracture, oblique in the lateral pole area, frequently associated with laceration of the lateral capsule ligament and loss of vertical height Type C – Very high condylar neck fracture near the lateral capsular insertion, resulting in a displacement of the condylar head as a whole 1

Neff, A. Funktionsstabile Osteosynthese bei Frakturen der Kiefergelenkwalze: Ergebnisse experimenteller und klinischer Untersuchungen, Cuvillier Verlag, Göttingen, 2003, ISBN 3-89873-936-8

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:  Loosening of the implant from 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  Complications in implant removal from improper explantation of the implant

Warnings and Precautionary Measures     

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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 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

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 Implants are generally designed to remain in the body temporarily and be removed after sufficient (osseous) healing has taken place.

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.

Components 0.9 mm 1.8 mm

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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! All of the implant components are intended for single use and may not be reused under any circumstances 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 an imprecise fit between implants and instruments, or similar, can represent a risk to the user, patient or third parties The sterilizing and implant containers as well as the instrument trays 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

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

Instructions for clinical use Preparing the screw bed with the twist drill: When using the twist drill to prepare the screw bed, make sure that the implant bed has been properly prepared:  When working monocortically, the drilling depth must be at least equivalent to the screw length. Otherwise, the screw may be overtightened, causing the screw head to shear off or become damaged. An exception to this is the mandibular condyle, where a 6 mm screw can easily be positioned in the spongiosa through a 5 mm drill hole  Use correctly sized twist drills! Select the twist drill according to the color coding system  The direction of screw insertion must follow the direction of drilling (coaxiality; otherwise, the screw/blade connection may be damaged due to a disproportionate increase of the tightening torque

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 the responsibility of hospital practice 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 cleansers, disinfectants and equipment Observe the following when choosing cleansers, disinfectants and equipment at all steps:  They must be suitable for their intended use (e.g. cleaning, disinfection or ultrasonic cleaning)  The cleansers and disinfectants must be aldehyde-free (other means of fixation of blood contamination)  The disinfectant used must have a proven effectiveness (such as approval by VAH/DGHM or the FDA, or a CE mark)  The cleansers and disinfectants must be suitable and compatible for use with the items  The manufacturer's instructions, such as those regarding concentration, standing 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 or soft brushes (never use metal brushes or steel wool)  When necessary, use materials and accessories such as cleaning rods, syringes, cannulas and bottle brushes for cannulated items or items with a lumen For drying items, Medartis recommends lint-free disposable paper wipes or medical grade compressed air. For water quality, Medartis recommends that demineralized and purified water (e.g. purified water) be used for cleaning, disinfection and subsequent rinsing steps. Medartis instrument trays (steel or plastic) and implant trays made from aluminum or plastic are intended for the sterilization, transportation and storage of items. They are not intended for cleaning and disinfection when loaded. The items must be removed from the trays and then cleaned and disinfected separately. Remove major contaminants in the operating room before returning the instruments to the tray. It is preferable to remove contaminants using a dry method. If contaminants are removed using a wet method, place the instruments in a prepared solution directly after they have been used.

MANDIBLE-00000301_Rev. F 2015/10/02 Instructions for use for Medartis MODUS CFS 1.8 grid plate, screws and instruments Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG, 4057 Basel/Switzerland

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