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Instructions for Use for Medartis MODUS 2 Systems I.
General Instructions
These instructions for use do not include all of the information necessary for use of the products. Additional information on the products (e.g. surgical techniques, instructions for handling of sterile products, instructions for reprocessing and maintenance, assembly/disassembly instructions) can be found on the internet at www.medartis.com/documentation/instructions-for-use. They can also be requested from your local Medartis territory consultant or distribution partner. All instructions provided in this document and in the corresponding user information must be followed. 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.
II.
Scope
Implants and instruments for the following MODUS 2 systems are covered by these instructions for use: • • • • •
MODUS 2 Midface MODUS 2 Mandible MODUS 2 Orthognathics MODUS 2 Intermaxillary Fixation MODUS 2 Transbuccal Set
The complete list of items can be found in the corresponding surgical technique(s) under www.medartis.com/documentation/instructions-for-use.
III.
Product Description
system and on patient-related factors (e.g. activity, occupation, mental health, age, bone quality).
Intended Performance The available clinical data confirms good clinical performance and safety outcomes in a wide range of indications of the MODUS 2 systems, when they are used according to the user information. This is in line with or superior to the state of the art.
IV.
The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, or incorrectly combined implant components.
V. • • • •
Product Materials Medartis implants and instruments are manufactured from biocompatible materials. All materials are standard implant and instrument materials for use in medical devices for orthopedics, traumatology, and general surgery.
•
Product
Material
Plates
Pure titanium, titanium alloy
Screws
Titanium alloy
Instruments
Stainless steel, PEEK, aluminum, Nitinol, silicone or titanium
•
Containers
Stainless steel, aluminum, PEEK, polyphenylsulfone, polyurethane, silicone
• •
Color Coding Concept MODUS 2 instruments are color coded according to the diameter of the screws being used: Screw Diameter
Color Code
1.2
Red
1.5
Green
1.8
Yellow
2.0
Blue
2.3
Brown
2.5
Purple
Fixation plates (rigid)
Implant plates blue
Fixation plates (semi-rigid)
Implant plates silver
TriLock plates (locking)
Implant screws gold
Cortical screws (fixation)
Implant screws silver
TriLock screws (locking)
Implant screws green
SpeedTip screws (self-drilling) SpeedTip TriLock screws (self-drilling and locking) IMF SpeedTip screws (self-drilling)
Intended Purpose The MODUS 2 osteosynthesis systems are intended for oral and craniomaxillofacial surgery.
Indications and Contraindications Indications and contraindications for each MODUS 2 System can be found in the corresponding surgical technique under www.medartis.com/documentation/instructions-foruse.
Intended User / Patient Target Group The products may only be used by health care professionals, e.g. surgeons, radiologists, operating room staff, and individuals involved in preparation of the device, who hold the relevant qualifications. Medartis, as the manufacturer, recommends that the user reads all available documents (e.g. surgical techniques, instructions for handling of sterile products, instructions for reprocessing and maintenance, assembly/disassembly instructions) before first use and contacts other users who have practical experience with this type of treatment. The user must be familiar with the state of the art and the instrument and implant function. For specific patient target groups related to each system refer to the corresponding surgical technique of the system being used. Responsibility for proper selection of patients rests with the surgeon, based on the specific indications and contraindications of each
Instructions for Use for Medartis MODUS 2 Systems − R_MODUS2-00000101, Version B, 2022-04-11
Warnings
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. All of the implant components are intended for single use and may not be reused under any circumstances. Unless otherwise expressly stated on the label, the instruments can be reused. Necessary care must be observed for storage and use of the products: o 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. o Repeatedly bending the plate in opposite directions may cause the plate to break during postoperative treatment. Twist drills: It is recommended not to exceed a maximum drilling speed of 1’000 revolutions per minute to avoid overheating the bone. The drill guide and bone should be cooled while drilling. Reusable, non-sterile packaged twist drills may only be used for a maximum of ten times. Sterile packaged twist drills are for single use only and may not be reused under any circumstances. Never use products that have been damaged by transport, improper handling in the hospital, or in any other way! The sterilizing cases, instrument trays and implant containers shall not be vigorously shaken or tipped over since the individual components and content may become damaged or fall out. Compatibility information: MODUS 2 implants and instruments are not compatible with other MODUS systems in terms of color concept.
For application-specific warnings related to MODUS 2 systems, it is mandatory to consult the surgical technique (www.medartis.com/documentation/instructions-for-use) of the corresponding product system being used.
VI. •
MODUS 2 plates and screws have their own color, corresponding to a specific implant technology: Implant plates gold
Side Effects / Possible Complications
In most cases, potential complications have a clinical or patient-related 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 or implant breakage • 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 (e.g. due to bony ingrowth)
•
Cautions
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. Use the indicated screwdriver for the respective screw diameter. 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.
For application-specific cautions related to MODUS 2 systems, it is mandatory to consult the surgical technique (www.medartis.com/documentation/instructions-for-use) of the corresponding product system being used.
VII.
General Important Information
Clinical Benefits In consideration of patient’s clinical condition and medical history, the treating physician shall ensure that the use of MODUS 2 systems can be justified based on a patient-specific benefit/risk assessment. Based on the clinical evaluation and risk analysis, all residual risks are deemed acceptable when weighed against the benefits to the patient based on current knowledge/the state of the art.
Selecting the Appropriate Implants Medartis, as the 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 must 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. 1 of 3
Removal of 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.
Consult instructions for use
Postoperative Care
Article number / Reference number
Taking into account the individual fracture conditions and patient compliance, it is important 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
Lot number / Batch code
Information on MR-Marking
Serial number
Non-sterile Conditionally MR safe Non-clinical tests under worst case conditions show that all Medartis implants are MR conditional.
Single-use product. Do not reuse
Magnetically Induced Torque and Displacement According to ASTM F2213-06 and ASTM F2052-06e1 Non-clinical tests in a 3T MRI system under worst conditions have shown that no relevant torque and displacement of Medartis products were observed at a maximum spatial gradient of 12 T/m.
The product is intended for one single application in a single patient. Application of an already used product may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury.
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.
Do not resterilize Resterilization can result in implants not being sterile, and/or not meeting performance specifications and/or altered material properties. Resterilization may also compromise their structural integrity and/or lead to failure.
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 (1.5 T) and 4.2°C (3 T) after 15 minutes of continuous scanning (Normal Operating Mode, whole body specific absorption rate (SAR) of 2.1 W/kg).
Sterile product. Sterilized using irradiation
Since the above test results were obtained through non-clinical tests, the actual in vivo temperature increase will depend on a variety of factors beyond the SAR and 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.
VIII.
The product has been subjected to a validated irradiation sterilization process and is supplied in sterile packaging. Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use any product where the sterile packaging has been opened or damaged and do not remove them from the packaging until immediately before use. Once the sterile packaging has been opened, the product cannot be resterilized. Sterility of the device must be ensured at all times. The device is for single-use only and may not be reused under any circumstances. Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury.
Cleaning, Disinfection and Sterilization of Non-Sterile Products
All implants and instruments in the MODUS 2 systems that are delivered NON-STERILE must be cleaned, disinfected and sterilized before each use. This also applies to the first use after delivery. All packaging must be removed before preparation. 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 container/tray. It is your responsibility to ensure that the implants 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. Detailed instructions for processing/reprocessing of medical devices are described in the brochure “Instructions for Cleaning, Disinfection, Sterilization, Inspection and Maintenance of Medartis Products” and can be downloaded from www.medartis.com/documentation/instructions-for-use.
IX.
Do not use if packaging is damaged
Medical device
Use-by date
YYYY-MM-DD Manufacturer Date of manufacture
Complaints and Adverse Events YYYY-MM-DD
Any complaint or adverse event that has occurred in relation to the device should be reported to the manufacturer and the respective national competent authority of the state in which the user and/or patient is established.
X.
References
The following user documentation on the products is additionally available online and can be found under the following link www.medartis.com/documentation/instructions-for-use: - Surgical techniques - Instructions for handling of sterile plates, screws, staples and instruments - Instructions for cleaning, disinfection, sterilization, inspection and maintenance - Assembly/disassembly instructions For additional information contact your local Medartis territory consultant, distribution partner or the manufacturer directly under the given address.
XI.
YYYY-MM-DD
Date of manufacture
Conditionally MR safe
Authorized representative in the European Community / European Union
Symbols Importer
Instructions for Use for Medartis MODUS 2 Systems − R_MODUS2-00000101, Version B, 2022-04-11
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TriLock plates (locking)
HexaDrive
Self-drilling screws
Applies only to EC risk class I devices in sterile condition, I devices with a measuring function, I reusable surgical instruments, IIa and IIb devices.
Applies only to EC risk class I devices.
This document is subject to continuous revision. The most current version is always available online at www.medartis.com/documentation/instructions-for-use.
Medartis AG Hochbergerstrasse 60E 4057 Basel/Switzerland Phone +41 61 633 34 34 Fax +41 61 633 34 00 [email protected] www.medartis.com
Importer EU Medartis GmbH Am Gansacker 10 79224 Umkirch/Germany
Medartis GmbH Am Gansacker 10 79224 Umkirch/Germany Sponsor Details Australia & New Zealand Medartis Australia & New Zealand Pty Ltd. 64 Brooks Street Fortitude Valley QLD, 4006 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 physician.
Instructions for Use for Medartis MODUS 2 Systems − R_MODUS2-00000101, Version B, 2022-04-11
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