MODUS Plates, Screws and Instruments Instructions for Use

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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 aligned in axial direction. 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. Implants can cause artifacts in various imaging procedures such as MR.

Information on MR-Marking

Taking into account the individual fracture conditions and patient compliance, it is important for the surgeon to ensure adequate postoperative relief of the osteosynthesis in terms of adaptation- or mobilization stability (e.g. splinting and/or immobilization). Postoperatively, the fixation achieved with the implants must be treated with care until the bone has fully healed. Patients must strictly observe follow-up instructions given by their physicians to avoid detrimental strain on the implants. Early load bearing can increase the risk of loosening, migration or breakage of the implants. In the case of complications, it might be necessary to remove the implants. For removal use the indicated screwdriver. Make sure that the screwdriver/screw head connection is precisely aligned in axial direction.

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.

Single-Use Device Conditionally MR safe Non-clinical tests under worst case conditions show that all Medartis implants are MR conditional. Magnetically Induced Torque and Displacement According to ASTM F2213-06 and ASTM F2052-06e1 Non-clinical tests in a 3T MRI system under worst case conditions have shown that no relevant torque and displacement of Medartis products were observed at a maximum spatial gradient of 12 T/m. Image Artifacts According to ASTM F2119-07 Non-clinical tests in a 1.5T MRI system showed image artifacts extending up to 29 mm away from the implant during a gradient echo pulse sequence. Radio-Frequency Induced Heating According to ASTM F2182-11a Electromagnetic and thermal simulations combined with non-clinical tests demonstrated maximum temperature rises of 13.1°C (1.5T) and 4.2°C (3T) after 15 minutes of continuous scanning (Normal Operating Mode, whole body absorption rate (SAR) of 2.1 W/kg). Since the above results were obtained through non-clinical tests, the actual in vivo temperature increase will depend on a variety of factors beyond the SAR and the scan duration. Therefore, note the following: • Do not scan patients with impaired thermo regulation, temperature or pain sensation. • Reduce the SAR as much as possible, as reducing the SAR strongly reduces the temperature increase caused by RF heating. • Use an external cooling/ventilation system to help reduce the body temperature .

Multidirectional, Angular Stable TriLock Locking System Correct locking (±15°) of the TriLock screws in the plate Visual inspection of the screw head projection provides an indicator of correct locking. Correct locking has occurred only when the screw head has locked flush with the plate surface (Fig. 1 and 3). However, if there is still a noticeable protrusion (Fig. 2 and 4), the screw head has not completely entered the plate and reached the locking position. In this case the screw has to be retightened to obtain full penetration and proper locking. In case of poor bone quality a slight axial pressure might be necessary to achieve proper locking. Due to the system characteristics, a screw head protrusion of around 0.2 mm exists when using plates with 1.0 mm thickness. Do not overtighten the screw, otherwise the locking function cannot be guaranteed anymore. Correct: LOCKED

Incorrect: UNLOCKED

The product is intended for one single application in a single patient. Application of an already used device may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury.

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. All implant components are intended for one single application in a single patient. Implants that were used in a patient and removed, have to be discarded following the local requirements. Application of an already used device may compromise the structural integrity of the implants and/or lead to device failure which may result in patient injury. Furthermore, application of an implant that has already been used may create a risk of contamination e.g. due to the transmission of infectious material from one patient to another. This could result in injury of the patient or user. Implants that have not come into direct contact with a patient may be reprocessed. Implants that have come into 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

Fig. 1

Fig. 2

Correct: LOCKED

Incorrect: UNLOCKED

Fig. 3

Fig. 4

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, practice of the surgical procedure and postoperative treatment

Generally, implants are designed to remain in the body temporarily and be removed after sufficient (osseous) healing has taken place. They are not designed for long term bone replacement. Where they are mechanically supporting the osteosynthesis, the regular operating period of the implants is expected to be between 30 days and 6 months.

MODUS-00000101_Rev. O 2021/04/22 Instructions for Use for Medartis MODUS Plates, Screws and Instruments

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 a CE marking) • 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 (e.g. Perform classic from Schülke & Mayr) and/or soft brushes (e.g. Justman Brush from VWR International). 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 For drying accessories, Medartis recommends lint-free disposable wipes (e.g. Perform classic from Schülke & Mayr) or medical compressed air. For water quality, Medartis recommends that demineralized and purified water (e.g. Aqua purificata) is 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 products. They are not intended for cleaning and disinfection when loaded. The products must be removed from the trays and then cleaned and disinfected separately. Implant trays from the MODUS Clip Case system can undergo automated cleaning and disinfection when loaded. For manual cleaning, the clips must be removed from the system and then cleaned and disinfected separately. However, the implants must always be left in the clip and can also be cleaned and disinfected manually in this state. Remove major contaminants in the operating room before segregating dirty instruments. Preferably use dry preparation for the transportation to the cleaning/sterilization department. If a wet preparation method is used, place the instruments in a prepared solution directly after usage. The instruments must be disassembled and opened as much as possible. All products

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(including grooves, holes, lumens, etc.) must be sufficiently covered with solution. To avoid damage to the materials, do not leave them in the solution for longer than directed. Pretreatment Prior to Cleaning, Disinfection and Sterilization Pretreatment process • Disassemble and open the instruments as far as possible. When doing so, follow the assembly and disassembly instructions, which can be found at www.medartis.com. • Empty the instrument trays completely and remove the lid, if necessary. • Empty the aluminum or plastic implant trays completely and remove the lid if necessary; for steel implant trays, the implants can be left in the tray but the lid must be removed during the rinsing process and rinsed separately. • Clip system: with implant trays from the Clip Case system, the implants must not be removed from the clips; keep the clips in the trays for pretreatment. • Clean products and individual parts under running water using soft brushes (shift moveable parts back and forth, use cleaning wire, syringes and cannulas for cannulated products; for larger lumina, use a bottle brush if necessary). • Visually inspect the products and repeat pretreatment as required until visible contamination is no longer evident. The disassembled instruments and trays should remain dismantled for the following cleaning and disinfection process. Manual Cleaning and Disinfection For manual cleaning and disinfection, the trays have to be empty. Instruments and trays must be opened and disassembled as far as possible. Implants must be removed from the system and must be cleaned and disinfected separately. Clip system: the clips must be removed from the trays for manual cleaning and disinfection; implants must be left in the clip. Manual Cleaning Process • Place the (disassembled) products in the cleaning bath with enzymatic cleaning solution (e.g. CIDEZYME® Enzymatic Detergent Solution, 1.6% v/v) for 5 minutes. The products must be adequately covered and the individual components should not be in a position to damage each other. Follow the enzymatic cleaner manufacturer’s instructions for use for correct exposure time, temperature and concentration. • Clean with a soft plastic brush (e.g. Justman Brush from VWR International). • Shift moveable parts back and forth several times. • Clean large lumina with a bottle brush. • Cannulated products (with cavities whose diameter is less than or equal to 1/6 of the device‘s length), e.g. cannulated drills, must be cleaned by inserting the dedicated cleaning stylet and rinsed using a suitable cannula and disposable syringe (rinsing volume: 30 ml). • Clean the products in the ultrasonic bath for 15 minutes using a suitable detergent (e.g. CIDEZYME® Enzymatic Detergent Solution, 1.6% v/v). Follow the enzymatic detergent manufacturer’s instructions for use for correct exposure time, temperature and concentration. • Rinse with cold (T < 40°C) or warm (T > 40°C) water for at least one minute (lumina and cannulated products must also be rinsed inside using syringes and suitable cannulas); hand-held water jets can also be used. • Visually inspect the products and repeat the cleaning process as required until visible contamination is no longer evident. • Inspect the products (see the section «Inspection»). Manual Disinfection Process • Place the (disassembled), cleaned and inspected products in the disinfection bath for 15 minutes (e.g. CIDEX® OPA Solution). The products must be adequately covered and the individual components should not be in a position to damage each other. Follow the enzymatic disinfection solution manufacturer’s instructions for use for correct exposure time, temperature and concentration. • Shift moveable parts back and forth several times. • Large lumina must also be filled on the inside. • Cannulated products (with cavities whose diameter is less than or equal to 1/6 of the device‘s length), e.g. cannulated drills, must be filled with disinfectant and rinsed using a syringe and suitable cannula (rinsing volume: 30 ml). • Rinse with cold (T < 40°C) or warm (T > 40°C) water for at least one minute (lumina and cannulated products must also be rinsed inside using syringes and suitable cannulas); hand-held water jets can also be used. • Visually inspect the products and repeat the cleaning and disinfection process as required until visible contamination is no longer evident. • The products must be completely dried directly afterwards (it is recommendable to dry them using medical compressed air). • Inspect the products (see the section, «Inspection») and service them (see the section, «Product Care»). • Pack the products preferably immediately or if necessary after giving them additional time to dry. Automated Cleaning and Disinfection For automated cleaning and disinfection instruments have to be removed from the trays. Instruments have to be opened and disassembled! Implant trays made of aluminum or plastic are not intended for cleaning and disinfection when loaded. Implants must be removed from the trays and must be cleaned/disinfected separately. With the clip system, ensure that the implant trays have been properly sealed with their lid before automated cleaning. The above recommendations must also be followed when choosing detergents and disinfectants for this process. For automated cleaning, ensure that the products have been rinsed thoroughly and that there is no remaining foam. When selecting the disinfector, make sure: • That the cleaning process includes the following phases in accordance with EN ISO 15883: Phase

Temperature

Duration

Action

Cleaning

55°C (±2°C) (131°F; ±3.6°F)*

10 min.*

Adding detergent*

Neutralization

Cold (T < 40°C/104°F)

2 min.

Neutralize with cold water

Rinsing

Cold (T < 40°C/104°F)

1 min.

Rinse with cold water

MODUS-00000101_Rev. O 2021/04/22 Instructions for Use for Medartis MODUS Plates, Screws and Instruments

Thermal disinfection (Ao value > 3’000)

≥ 90°C (194°F)

5 min.

With demineralized and purified water; do not add additional detergent

Dry

Device-specific (T < 141°C/286°F)

Device-specific

Drying process

* The information provided refers to the use of «Neodisher MediClean forte» by Dr. Weigert; the validation was performed with a concentration of 0.2 % at 50°C; if a different detergent is used, exposure times, concentrations and temperatures may vary; the relevant manufacturer's instructions must be observed. When loading the disinfector, use the loading layouts provided by the manufacturer; also follow the detailed information provided in «Instructions for Cleaning, Disinfection and Sterilization» at www.medartis.com. Inspection (Implants and Instruments) Before assigning the implants to the implant containers/trays, check them after cleaning and disinfection for damage and contaminants, and remove damaged and contaminated implants. Clip system: the implants must not be removed from the clips. Once removed from the clip, implants must not be re-inserted into the clip and must be discarded. After the instruments are cleaned and disinfected, check them all for damage (e.g. corrosion, damage to surfaces, chipping, etc.), contaminants and function. Remove damaged instruments. In addition, instruments with lumina (e.g. cannulated drills) have to be checked for free passage without obstructions, cutting instruments must be checked for sharpness and rotating instruments must be checked for bending. Instruments that are still soiled must be cleaned and disinfected again. You can find further details at www.medartis.com in «Instructions for Cleaning, Disinfection and Sterilization». Product Care Carefully apply maintenance products (paraffin-based/white oil-based, biocompatible, steamsterilizable and steam-permeable) to the articulations, closures or threads and sliding surfaces. Do not use maintenance products containing silicone. The disassembled instruments and trays should be reassembled for the following sterilization process. Clip system: the clips must be sorted into the implant trays for sterilization. Sterilization Medartis recommends sterilizing the products in the specially designed MODUS sterilization containers, implant containers and instrument trays. If the total weight of the loaded module is over 10 kg, the module must not be sterilized in a sterilization container; rather, wrap it in sterilization paper and sterilize it according to state of the art techniques and using approved methods. Steam Sterilization All NON-STERILE products can be sterilized in an autoclave (EN 13060 and EN 285). For both initial and subsequent sterilization, the following parameters were validated by Medartis in accordance with the requirements of the current sterilization standards, EN ISO 17665 and ANSI/AAMI ST79: Procedure

Fractionated and Dynamic Prevacuum Process

Flow and Gravitation Processes

Exposure time

≥ 4 min

≥ 15 min.

Temperature

132°C/134°C

132°C/134°C

Drying time

> 20 ─ 30 min.

> 20 ─ 30 min.

Medartis recommends that sterilization is performed in accordance with the above validated processes. If the user utilizes other processes (e.g. flash sterilization), these must be validated by the user. The ultimate responsibility for validation of sterilization techniques and equipment lies with the user. Outside the USA: the sterilization time can be extended to 18 minutes to meet the recommendations of the WHO and the Robert Koch Institut (RKI). Medartis products are designed for these sterilization cycles. Do not use hot-air sterilization, radiation sterilization, formaldehyde sterilization, ethylene oxide sterilization or substitute procedures for sterilizing thermolabile products such as plasma or peroxide sterilization for Medartis products. After sterilization, the products must be stored in a dry and dust-free environment. Reusability (Implants and Instruments) All implant components are intended for one single application in a single patient. Implants that were used in a patient and removed, have to be discarded following the local requirements. Application of an already used device may compromise the structural integrity of the implants and/or lead to device failure which may result in patient injury. Furthermore, application of an implant that has already been used may create a risk of contamination e.g. due to the transmission of infectious material from one patient to another. This could result in injury of the patient or user. Implants that have not come into direct contact with a patient may be reprocessed. Implants that have come into 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. The instruments can be reused if corresponding precautions are observed and if they are undamaged and uncontaminated. No liability is assumed by the manufacturer in case of non-observance. Medartis recommends: if products come in contact with pathogens that are difficult to identify such as variations of Creutzfeldt-Jakob’s disease (confirmed or suspected pathogen), they must be discarded. Manufacturer Medartis AG Hochbergerstrasse 60E 4057 Basel/Switzerland

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Consult instructions for use

Article number / Order number

Lot number

Non-sterile

Do not reuse

Do not use if package is damaged

Manufacturer

Medical device

Importer

Authorized representative

Applies only to EC risk class IIa and IIb medical devices

Applies only to EC risk class I medical devices

Conditionally MR safe

This document is subject to continuous revision. Please verify that the current printed version is identical to the one at www.medartis.com.

Importer EU Medartis GmbH Am Gansacker 10 79224 Umkirch/Germany

Medartis GmbH Am Gansacker 10 79224 Umkirch/Germany Disclaimer: This information is intended to demonstrate the Medartis portfolio of medical devices. A surgeon must always rely on her or his own professional clinical judgement when deciding whether to use a particular product when treating a particular patient. Medartis is not giving any medical advice. The devices may not be available in all countries due to registration and/or medical practices. For further questions, please contact your Medartis representative (www.medartis.com). This information contains CE-marked products. For US only: Federal law restricts this device to sale by or on the order of a physian.

MODUS-00000101_Rev. O 2021/04/22 Instructions for Use for Medartis MODUS Plates, Screws and Instruments

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