I.T.S PELVIC RECONSTRUCTION SYSTEMS 9 PRS , RX & PRS PHOENIX) Instructions for Use

INSTRUCTION FOR USE FOR NON-STERILE I.T.S. PELVIC RECONSTRUCTION SYSTEMS (PRS RX & PRS PHOENIX)

0297 ENGLISH CAUTION: USA LAW RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. THE INFORMATION BELOW SHOULD HELP WITH USING, CLEANSING, DISINFECTION, STERILIZATION AS WELL AS WITH INSPECTION OF WEAR AND TEAR OF MEDICAL DEVICES. Scope This instruction leaflet refers to all supplied non-sterile implants, all reusable instruments and trays from I.T.S. GmbH. All products, including those following direct delivery, must be cleaned, disinfected and sterilized before usage. The term medical device is summarized below for the following products: • Implant • Instrument The products are only mentioned by name, when the procedure differs. IMPORTANT INDICATIONS FOR SURGEONS AND SURGICAL STAFF Detailed information for the identification of the medical device (such as system classification, art. no., material) can be found in the product identification code and/ or on the packaging label. As a general rule, the user must be informed in detail about the intended applications, combination possibilities and correct handling before using the medical devices and must be qualified by appropriate training. Changes to product systems can also affect the compatibility of certain medical devices with each other. Before the user uses the I.T.S. GmbH medical device, all available documents must be read carefully. Detailed user information can be found in the respective surgical instructions. Intended purpose The implant and the needed instruments temporarily stabilises bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed. The surgeon in charge decides when to explant the implant. I.T.S. GmbH recommends the explantation of the implant after full bone recovery – as far as it is possible and applicable for the individual patient. Detailed user information can be found in the respective surgical instructions. Indications The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include: • Fractures of the acetabulum • Fractures of the pelvic ring • Fractures of the quadrilateral surface • Fractures of the symphysis • Fractures of the ilium • Fractures of the SIJ • Ilio-iliac distance osteosynthesis • Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations • Revision surgery of pseudoarthroses, non-unions and mal-unions Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include: • Fractures involving the Posterior Wall & Posterior Column • Fractures involving the Anterior Column of the Acetabulum • Fractures involving the Quadrilateral Surface • Symphyseal Disruptions & Para-symphyseal Fractures • Fractures of the ilium • Fractures of the SIJ • Dorsal neutralization plating for posterior pelvic ring fractures • Osteotomies, arthrodesis and sacroiliac joint dislocations • Revision surgery of pseudoarthroses, non-unions and mal-unions Indications for use of the I.T.S. Infra-acetabular screw placement include: • Fractures involving the anterior column, e.g. anterior column, anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include: • Pelvic fractures Contraindications • Existing infections in the fracture zone and operation area • Common situations that do not allow osteosynthesis with advanced osteoporosis • Obesity • Lack of patient compliance The I.T.S. Pelvic Reconstruction System (PRS RX, PRS Phoenix, Infra-acetabular screw placement and 8.5mm Cannulated Screws & Washer) is not intended for spinal use. Patient target group The target group comprises persons whose condition corresponds to the indications of one of the systems distributed by I.T.S. - taking into account the contraindications. Designated users The intended users are limited to medical personnel with appropriate product training by the medical product consultants or knowledge of the surgical procedure to be applied. The medical staff must ensure that the use of I.T.S. GmbH medical devices is appropriate, taking into account the medical condition and medical history of the patient. Used material Plates and Screws: commercially available, pure titanium (CP) or Ti6AI4V-alloy (according to ASTM F67/DIN ISO 58322, ASTM F136/DIN ISO 5832-3). Furthermore, all implants are non-corrosive, non-toxic in the biological environment, biocompatible and enable X-ray and CT imaging practically free of artifacts. Instruments: stainless steel, aluminum, plastics Side Effects of the Implant • Implant failure due to wrong implant selection and/or overloading of the implant • Allergic reactions due to material incompatibility • Delayed healing due to vascular defect • Pain caused by the implant Allergic reactions to steel implants cannot be ruled out. Warnings and Preventive Measures • Pay attention to the instructions on the packaging. • Implants are for single use. • Always treat medical devices carefully to avoid surface damage or geometric alterations. • Any alterations to the design of medical devices from I.T.S. GmbH are prohibited. • Regular postoperative follow-up examinations (e.g. X-ray check-ups) are to be carried out. • For metallurgical, mechanical and design reasons, never combine medical devices from different manufacturers. The materials used are stated in the product catalogue or on the label. I.T.S. GmbH assumes no liability for possible complications resulting from the combination of I.T.S. GmbH medical devices with implants/instruments from other manufacturers. • The length, angle and right or left version of a particular type of implant can differ. • The precise positioning and fastening of a properly made connection between the implant and instrument must be repeatedly checked during the course of an operation. • Medical devices marked with the Symbol on the label are for single use and thus, must not be reused. • Implants that have been inserted and removed from a patient must be disposed of according to local requirements. They must not be reprocessed, as the reuse of disposable products creates a risk of contamination, for example through the transmission of germs from patient to patient. This may result in injury and/or illness of the patient and/ or user. • Medical devices that have come into direct contact with a patient‘s blood or other bodily fluids or that have visual contamination must be cleaned and disinfected separately before they can be put back into the appropriate container. • Medical Devices that have not come into direct contact with a patient can be reprocessed.

I.T.S. GmbH Autal 28, 8301 Lassnitzhöhe, Austria Tel.: +43 (0) 316 / 211 21 0 Fax: +43 (0) 316 / 211 21 20 [email protected] www.its-implant.com

• Staff who come into contact with contaminated or potentially contaminated medical products should follow the generally recognised preventive measures. Due care is to be taken when handling medical products with sharp points or edges. • Appropriate protective measures must be taken to ensure safe handling when dealing with contaminated or potentially contaminated medical products (e.g. gloves, etc.) • In countries with stricter safety requirements regarding recycling medical products, these safety requirements apply and are to be adhered to. • Any supplied non-sterile medical products must be thoroughly prepared according to these instructions before use. • No metal brushes or abrasive cleaning materials are to be used for manual cleaning purposes. The use of these materials can lead to damage of surfaces and coatings. Instead, soft brushes made of nylon should be used. • Steam (damp heat) is the recommended sterilization method of medical products from I.T.S. GmbH. • All the following described steps for cleaning and sterilization are made easier when contaminants (e.g. blood) are not allowed to dry beforehand. • Medical devices supplied non-sterile must be thoroughly reprocessed in accordance with these instructions before use. The manufacturer excludes all liability in the event of non-compliance. • To avoid damage to the drive profile of the screwdriver, compatibility and a positive connection between the screwdriver and the screw head must be ensured. • Excessive shaping / deformation, notching or scratching of the implant should be avoided, as it can lead to damage to the surface or even failure of the medical device. • Placing excessive strain too early where the product was implanted can lead to symptoms of fatigue or even failure of the medical device. Therefore, the medical staff must inform the patient about postoperative behavior. MRI Safety Information • The Pelvic Reconstruction System PRS RX & PRS Phoenix has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of the Pelvic Reconstruction System PRS RX & PRS Phoenix in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction. Patient Information Implantation has consequences for the discomfort, mobility and general life circumstances of the patient. For this reason, the necessity and the importance of reporting negative changes in the area of the implant as well as any falls and accidents which may appear not to have damaged the implant or the site of the operation should be explained to the patient. Patients who are not able to follow the surgeons instructions due to a mental or neuromuscular disorder should note that the risk of postoperative complications (e. g. B. implant failure) is higher. Restrictions • Unless otherwise stated, repeated preparation of medical devices of I.T.S. GmbH has minimal effects when following the procedures mentioned below. • The end of the product service life is usually determined by wear and damage caused by use why functional tests and careful inspections both before cleaning and before use are essential for determining the product‘s life expectancy. • Instruments containing aluminium or anodised aluminium can be damaged by alkaline (pH value > 7) cleaning agents and solutions. Packaging The delivery packaging (plastic pouch/ cardbox board) of non-sterile medical devices is mere for transport purposes and is not suitable for sterilisation. The medical institution is responsible for in-house procedures regarding assembly, inspection and packaging of medical devices. Packaging is carried out in accordance with the general standard packaging guidelines of relevant standards and guidelines of specialist organisations using sterile barrier systems that conform with standards. Trays must not be stacked within the sterilization container or sterilization wrap and in the autoclave during sterilization as doing so may negatively impact ventilation and sterilization. INSTRUCTIONS FOR PROCESSING OF NON-STERILE MEDICAL DEVICES Preparation at the location of use • Remove surface dirt using a disposable cloth or paper towel. Rinse out the hollow parts with aqua destillata (distilled water). Saline solution (NaCl) may only be used if processing is carried out immediately afterwards - risk of corrosion! Transport • It is recommended that medical products are reconditioned as soon as possible after their previous use as dried dirt adhesion makes cleaning more difficult. • The trays used by I.T.S. GmbH are not intended to be subjected to the cleaning and disinfection process defined below when loaded. I.T.S. GmbH trays are suitable and recommended for sterilization, transport and storage. • To avoid risks of contamination, used medical devices must be transported to the reprocessing site in a closed or covered container. • Avoid damage to the medical devices by not placing heavy products on top of delicate products, by not allowing sharp cutting edges to damage other products or by not overfilling the transport container. Cleaning and disinfection Only effective cleaning of the medical devices guarantees effective disinfection/sterilization. In the following, the universal manual cleaning/disinfection is described in addition to the automated machine cleaning/disinfection. Due to the lower effectiveness of manual cleaning/disinfection, mechanical cleaning/disinfection should be the method of choice. It must be ensured that fresh solutions are always used. The following documented procedures are validated procedures of I.T.S. GmbH. Cleaning preparation Each instrument that can be dismantled should be dismantled for cleaning after being taken out of the tray. Pre-cleaning I.T.S. GmbH recommends a pre-cleaning for heavily soiled medical devices. The following points must be observed: • The disassembled instruments are cleaned under running water. • Visible soiling of the surface, lumens and cannulations can be removed with soft brushes. • Movable parts can be pre-rinsed under running water by back and forth movements. • Cannulas can be cleaned with cleaning wire, syringes and cannulas. Alternatively, the pre-cleaning of medical devices can be carried out in an ultrasonic bath. After cleaning, the medical devices must be visually checked for contamination and the steps repeated if necessary. If cleaning is not continued immediately, dry the products with a lint-free soft textile cloth to avoid oxidation. Automatic cleaning/disinfection (recommended) Only a washer-disinfector (WD) that conforms to standards (in accordance with EN ISO 15883) and that is regularly maintained and inspected should be used for automatic cleaning and disinfection in accordance with the manufacturer‘s information. Recommended equipment: Appropriate loading trolleys to accommodate all medical devices (e.g. instrument trolleys with MIC bar, MIC trolleys); commercially available cleaning agent authorised for use with medical devices (pH value 9-11) e.g. Neodisher® Mediclean forte by Dr. Weigert. I.T.S. GmbH recommends the following validated steps for automatic cleaning and thermal disinfection. The basic device should be a Miele PG 8536 machine. Validation is carried out in accordance with EN ISO 15883 and guideline no. 3 of the Austrian Association for Sterile Services (ÖGSV).