TrueLok System Implantable Devices for External Fixators Instructions for Use

c.

A wire that has been inserted once should always be discarded if it is removed before tensioning (the tip may have become blunt and is the only cutting surface, so undesirable heating of the bone may occur) d. In case a wire with olive is used, the tensioning must be performed from the side opposite to the olive. Tension applied must be inferior to that of the other wires, thus avoiding excessive pressure on the bone cortex. 13. Wherever an implant wire or a guide wire is used to guide a cannulated reamer, drill bit or screw into position: a. The wire or guide wire should always be new b. The wire should be checked before insertion to exclude any scratches or bends c. During the introduction of any instrument or implant over a wire, the surgeon should screen the wire tip as continuously as possible to exclude inadvertently driving the wire further than intended d. During each pass of the instrument or implant, the surgeon should check that there is no bony or other debris built up on the wire or inside the instrument or implant which might cause it to bind on the wire and push it forward 14. If a cannulated drill bit is to be used for a second time on the same patient, the surgeon must check that the drill bit is free from obstruction, by removing it from the power unit and passing a wire through it. 15. Even when a cannulated drill bit is new, we recommend that a wire is passed through it prior to use, to check that the lumen is free from obstruction. THREADED WIRES (93100 and 99-93100) 1. Use the drill at low speed when inserting the wires into the bone. Galaxy UNYCO SCREWS 1. Uni-cortical screws must be inserted perpendicular to the bone surface using low rotation speed and a steady thrust to ensure optimal bone purchase. 2. In presence of prosthetic implants or internal fixation, use caution when inserting screws All Orthofix devices should be used together with their corresponding Orthofix implants, components, accessories and instrumentation following the Operative Technique recommended by the manufacturer. Orthofix does not guarantee the safety and effectiveness of the implantable devices for external fixators when used in conjunction with devices of other manufacturers or with other Orthofix devices, if not specifically indicated in the Operative Technique. POSSIBLE ADVERSE EVENTS • Tissue damage following the insertion of the implantable devices • Superficial infection • Deep infection • Loosening, bending, breakage or migration of the implantable devices • Bony damage due to inappropriate selection of implantable devices • Foreign body reactions due to implantable devices • Tissue necrosis secondary to the insertion of implantable devices • Bone sequestration secondary to rapid drilling of bony cortex with heat build-up and bone necrosis • Pain, discomfort or abnormal sensation due to the presence of the implantable device • Damage to the growth plate due to the incorrect insertion of the implantable device • Fracture of regenerate bone or through bone screw holes after implantable device removal • Events caused by intrinsic risks associated with anesthesia and surgery A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the medical device. Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the successful utilization of the device by the HCP. IMPORTANT Proper patient selection and the patient’s ability to comply with physician instructions and follow prescribed treatment regimen will greatly affect the results. It is important to screen patients and select optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindications or is predisposed to any contraindications, DO NOT USE Orthofix implantable devices. MRI SAFETY INFORMATION The Orthofix implantable devices for external fixation have not been evaluated for safety and compatibility in the MR (Magnetic Resonance) environment. They have not been tested for heating, migration, or image artifact in the MR environment, unless specified otherwise on the instruction leaflet specific of the external fixator they are used with. SPECIFIC INFORMATION ON THE DEVICE • Appropriate Orthofix instrumentation should be used to insert bone screws and wires correctly. • Screw length and thread length should be selected in accordance with bone and soft tissue dimensions. Thread length should be such that at least one full thread, but not more than 10mm, will remain outside the entry cortex. The screw tip should project just beyond the second cortex. • Screw diameter should be selected in accordance with bone diameter. The maximum diameter of the screw thread should not be greater than one third of the bone diameter (e.g. 6-5 or 6-5.6mm bone screws for bone diameter greater than 20mm). • For pre-drilled and blunt bone screws, pre-drilling with appropriate drill bits and drill guides prior to screw insertion through the screw guide is imperative. Matching grooves on screws and drill bits help the surgeon to use the correct drill bit. • Self-drilling screws may be inserted with a power drill at low speed with the exception of self-drilling conical screws with a thread diameter of 5mm or above that must be always inserted by hand or with a hand drill. • The XCaliber bone screws are removed with the T Wrench 4mm (93175) when the screw shaft is 4mm in diameter or with the T Wrench 6mm (91150) in case of 6mm shaft screws. • The XCaliber bone screws are designed to be self-drilling, and direct insertion with a hand drill is advised in most cases. However, when insertion of self-drilling screws is performed in diaphyseal bone, pre-drilling is recommended; use a 4.8mm drill bit through a drill guide when the bone is hard; when the bone quality is poor, or in the metaphyseal region where the cortex is thin, a 3.2mm drill bit should be used. Screw insertion, whether or not pre-drilling has been performed, should always be with the hand drill or T-Wrench only and through a screw guide. It is important that moderate force is applied for the screw to gain entry into the first cortex. Insertion can be completed with the T-wrench. In all cases the surgeon should be mindful of the amount of torque required to insert the screw. If it seems tighter than usual, it is safer to remove the screw and clean it, and drill the hole again with a 4.8mm drill bit, even if it has already been used. 3

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•

•

•

In case of conical screws, the screw thread tapers, for example, from 6.0 to 5.0mm between the shaft and the tip of the standard Orthofix screws, or from 6.0 to 5.6mm in the XCaliber™ screws. Cylindrical screws have a thread with constant diameter which allows them to be backed out following insertion. XCaliber Cylindrical Screws with quick connect should be inserted into the bone using the Rachet T Handle and the Screw Shaft Connection (93150 and 93155) or the Screw T Wrench QC (93160). During insertion, the screw should be held steady so that the insertion direction is maintained throughout the procedure. Transfixing pins are self-drilling and may be inserted with a power drill. Transfixing pins of 4mm diameter may be used in association with the PREFIX™ Fixator (they are connected to the Prefix Rods with two Transfixing Pin Clamps) or with the GALAXY FIXATION™ System. Transfixing pins of 6mm diameter may be used in association with the GALAXY FIXATION™ System (they are connected to Galaxy Rods with two Large Clamps). It is very important that screws are inserted with the correct procedure, so that they are parallel when in position. This is achieved by using screw guides in the provided templates or fixator clamps, and by pre-drilling the screw hole, when required, through the correct size of drill guide. The clamps should be tightened so that the screw guides are gripped evenly, and held in correct relationship to each other. For more stable fixation of a fracture with a fixator, we recommend that the nearest bone screw is applied fairly close to the fracture margin (a minimum of 2cm is recommended) and that these distances are equal on both sides of the fracture. When using the Small Blue DAF (Dynamic Axial Fixator), the ProCallus Fixator, or the XCALIBER™, a supplementary screw holder (10037 or 90037) is supplied to achieve this. In case of poor bone quality, the use of Orthofix OSTEOTITE™ bone screws is suggested.

THREADED WIRES (93100 and 99-93100) • These wires are used in association with the GALAXY FIXATION™ System. They have a cylindrical thread and can be backed out if necessary. • To insert these wires into the bone, use the dedicated Orthofix instrumentation. TrueLok SCREWS • TrueLok screws are not tapered and have a thread that has the same diameter throughout. • TrueLok screws are available in 4, 5, and 6mm diameters, each having a total length of 180mm and a thread length of 55mm. If the screw has to be inserted in areas wider than 50mm, XCaliber bone screws should be used. • TrueLok screws are self-drilling, self-tapping, and have a standard quick connect end for ease of use in the operating room. • TrueLok screws which have been cut to length could be removed manually with the Universal Chuck with T-Handle (17955) or with a power drill. Galaxy UNYCO SCREWS • UNYCO Screws and UNYCO Cancellous Screws should be selected in accordance with bone type (cortical or cancellous). RISKS DUE TO THE RE-USE OF “SINGLE USE” IMPLANTABLE DEVICE* The “SINGLE USE” implantable device* of Orthofix is identified through symbol reported on the product label. After the removal from the patient, the implantable device* has to be dismantled. The re-use of implantable device* introduces contamination risks for users and patients. The re-use of implantable device* cannot guarantee the original mechanical and functional performances, compromising the effectiveness of the products and introducing health risks for the patients. (*): Implantable device: Any device intended to be totally / partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device. Product/s shall be stored in their original packages, in specific area protected against warmth source, humidity and dust, at Standard Conditioning Atmosphere. Product/s shall be protected from direct sunlight, ionizing radiation, extreme temperatures, particulate or microbial contamination. Product/s shall be protected during the transport to avoid potential damage. They do not require controlled temperature transport. STERILE & NON-STERILE PRODUCTS Orthofix devices are provided as STERILE or NON-STERILE and they are labeled as such. In the case of STERILE products, product integrity, sterility and performance are assured only if the packaging is undamaged: do not use if packaging is compromised or if a component is believed to be faulty, suspect or damaged. The products supplied NON-STERILE require cleaning, disinfection and sterilization prior to use according to procedures reported in the following instructions. INSTRUCTIONS FOR PROCESSING AND REPROCESSING These reprocessing instructions have been written in accordance with ISO17664 and have been validated by Orthofix in compliance with international standards. It is the responsibility of the health care facility to ensure that the reprocessing is performed in accordance with instructions provided. Warnings • Devices labeled “FOR SINGLE USE ONLY” can be reprocessed multiple times before their first clinical use but must not be reprocessed for re-use. • Single use devices MUST NOT BE REUSED, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release. • The personnel that works with contaminated medical devices must follow safety precautions as per the procedure of the healthcare facility. • Aluminum based devices are damaged by alkaline (pH>7) detergents and solutions. Refer to PQALU for the list of Orthofix aluminum based devices. • Cleaning and disinfection solutions with a pH 7-10.5 are recommended. Cleaning and disinfection solutions with a higher pH should be used according to the material compatibility requirements stated on the detergent technical data sheet. • Detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used. • The contact with saline solutions should be minimized. • Complex devices such as those with hinges, lumens or mated surfaces must be thoroughly manually pre-cleaned before automated washing in order to remove soiling that accumulates in recesses. • If a device needs particular care in pre-cleaning, a product specific IFU is available in Orthofix website, that is accessible using the data matrix reported on the product labelling. • DO NOT use metal brushes or steel wool. Limitations on reprocessing • Repeated reprocessing has minimal effect on reusable fixators and instruments. • End of life is normally determined by wear and damage due to use. • Products labeled for Single Use only MUST NOT be reused regardless of any reprocessing in a clinical setting. 4

POINT OF USE It is recommended to reprocess the reusable medical devices as soon as is reasonably practicable in order to minimize the drying of soil and residuals. For optimal results, instruments should be cleaned within 30 minutes of use. DO NOT use a fixating detergent or hot water because this can cause the fixation of residue. CONTAINMENT AND TRANSPORTATION It is recommended to cover contaminated instruments during transportation in order to minimize the risk of cross contamination. All used surgical instruments must be regarded as contaminated. Follow the hospital protocols for handling contaminated and bio-hazardous materials. Handling, collection and transportation of used instruments must be strictly controlled to minimize any possible risks to patient, personnel and any area of the healthcare facility. PREPARATION FOR CLEANING This procedure can be omitted in case of direct subsequent manual cleaning and disinfection. In case of highly contaminated reusable medical device before starting an automatic cleaning process, a precleaning and a manual cleaning (described in the following paragraph) are recommended. Manual Pre-cleaning 1. Wear protective equipment following safety precautions to comply with the procedure of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can be present. 3. Fill the receptacle with sufficient cleaning solution. Orthofix recommends the use of a slightly alkaline enzymatic detergent solution based on a detergent containing <5% anionic surfactants and enzymes prepared using deionized water. 4. Carefully immerse the component in the solution in order to displace trapped air. 5. Scrub the device in the cleaning solution with a soft brush until all visible soiling is removed. Use a soft brush to remove residuals from lumens, rough or complex surfaces using a twisting motion. 6. Rinse cannulations with cleaning solution using a syringe. Never use metal brushes or steel wool. 7. Remove the device from the cleaning solution. 8. Brush the single components in running tap water. 9. Clean the single components using an ultrasonic device in a degassed cleaning solution. 10. Rinse the components in purified sterile water until all traces of cleaning solution are removed. Use a syringe in case of lumens or cannulations. 11. Remove item from rinse water and drain. 12. Carefully hand-dry using a clean, lint free cloth. CLEANING General considerations In these instructions Orthofix provides two methods of cleaning: a manual method and an automated method. Wherever applicable, the cleaning phase should start immediately after the pre-cleaning phase to avoid soil drying. The automated cleaning process is more reproducible and therefore more reliable, and the staff is less exposed to the contaminated devices andto cleaning agents used. Staff shall follow the safety precautions to comply with the procedure of the healthcare facility using protective equipment. In particular, staff should take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product. Observe all instructions provided by the detergent’s manufacturer regarding the immersion time of the device in the cleaning agent/disinfectant and its concentration. The quality of the water used for diluting cleaning agents and for rinsing medical devices should be carefully considered. Manual cleaning 1. Wear protective equipment following safety precautions to comply with the procedure of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can be present. 3. Fill the receptacle with sufficient cleaning solution. Orthofix recommends the use of a slightly alkaline enzymatic cleaning solution. 4. Carefully immerse the component in the solution in order to displace trapped air; it is important to ensure that the cleaning solution reached all surfaces, including holes or cannulations. 5. Thoroughly scrub the device in the cleaning solution with a soft brush until all visible soiling is removed. Use a soft bristeled nylon brush to remove residuals from lumens, rough or complex surfaces using a twisting motion. 6. Rinse cannulations at least three times with cleaning solution using a syringe. Never use metal brushes or steel wool. 7. Remove the device from the cleaning solution. 8. Brush the single components in running tap water. 9. Put single components in ultrasonic device with degassed cleaning solution. Orthofix recommends the use of a detergent solution based on a detergent containing <5% anionic surfactants, non-ionic surfactants and enzymes, prepared using deionized water. Orthofix recommends on the basis of the validation performed to use an ultrasound frequency of 35kHz, power 300Weff, time 15 minutes. The use of other solutions and parameters shall be validated by the used and the concentration shall be in compliance with the detergent’s manufacturer technical datasheet. 10. Rinse the components in purified sterile water until all traces of cleaning solution are removed. 11. Rinse the cannulations, rough or complex surfaces at least three times with purified sterile water. When cannulations are present it is possible to use a syringe to facilitate this step. 12. Remove item from rinse water and drain. 13. If, after completion of the cleaning steps, some encrusted soil remained on the device and had to be removed with the brush, the cleaning step must be repeated as described above. 14. Carefully hand-dry using a clean, lint-free cloth. Manual disinfection 1. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can to be present. 2. Fill the receptacle with sufficient disinfectant solution. Orthofix recommends the use of a 6% hydrogen peroxide solution for 30 minutes prepared using water for injection. 3. Carefully immerse the component in the solution in order to displace trapped air; it is important to ensure that the disinfectant solution reached all surfaces, including holes or cannulations. 4. Rinse cannulations, rough or complex surfaces at least three time with disinfectant solution. Use a syringe filled with disinfectant solution to rinse cannulations. 5. Remove the items from the solution and drain. 6. Soak in water for injection (WFI) to remove traces of disinfectant solution. 7. Rinse the cannulations at least three times with a syringe (filled with WFI). 8. Remove item from rinse water and drain. 9. Repeat the rinsing procedure as described above. 10. Carefully hand-dry using a clean, lint-free cloth. 11. Visually inspect and repeat manual cleaning and disinfection if necessary. 5

Automatic cleaning and disinfection using washer-disinfector 1. Perform a pre-cleaning if necessary due to the contamination of the device. Take special care when the items to be cleaned contain or have: a. Cannulations b. Long blind holes c. Mating surfaces d. Threaded components e. Rough surfaces 2. Use a Washer-disinfector in compliance with EN ISO 15883 that is properly installed, qualified and regularly subjected to maintenance and testing. 3. Ensure that the cleaning receptacle is clean and dry, no visible foreign material can be present. 4. Ensure that the washer-disinfector and all services are operational. 5. Load the medical devices into the washer-disinfector. Place heavier devices in the bottom of the baskets. Products must be disassembled before placing them in the baskets according to the specific instructions provided by Orthofix. Wherever possible, all parts of disassembled devices should be kept together in one container. 6. Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer. 7. Avoid contact between devices because movement during washing could cause damage to devices and the washing action could be compromised. 8. Arrange medical devices in order to locate the cannulations in a vertical position and so blind holes incline downwards to promote the leakage of any material. 9. Use approved thermal disinfection program. When using alkaline solutions, a neutralizer must be added. Orthofix recommends that cycle steps are at least as follows: a. Pre-cleaning for 4 min b. Cleaning with the appropriate solution. Orthofix recommends the use of a detergent solution based on a detergent containing <5% anionic surfactants, non-ionic surfactants and enzymes, prepared using deionized water for 10 min at 55°C; c. Neutralization with basic neutralizing agent solution. Orthofix recommends the use of a detergent solution based on citric acid, concentration 0.1% for 6 min; d. Final rinsing with deionised water for 3 min; e. Thermal disinfection at least 90°C or 194°F (max 95°C or 203°F) for 5 minutes or until A0 = 30000 is reached. The water used for thermal disinfection must be purified. f. Drying at 110°C for 40 minutes. When the instrument has a cannulation, an injector should be used to dry the internal part. The suitability of other solutions, concentration, time and temperature shall be checked and validated by the user following the detergent manufacturer's technical datasheet. 10. Select and start a cycle according to the recommendations of the washer manufacturer. 11. On completion of the cycle, ensure that all stages and parameters have been achieved. 12. Wearing protective equipment, unload the washer disinfector when it completes the cycle. 13. If necessary, drain excessive water and dry by using clean, lint-free cloth. 14. Visually inspect each device for remaining soil and dryness. If soil remains, repeat the cleaning process as described above. MAINTENANCE, INSPECTION AND FUNCTION TESTING The following guidelines shall be applied to all Orthofix instruments that are labeled for multiple use. All functional checks and inspections described below also cover the interfaces with other instruments or components. The failure modes below may be caused by end of life of the product, improper use or improper maintenance. Orthofix does not typically specify the maximum number of uses for re-useable medical devices. The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the device before use is the best method of determining the end of the serviceable life for the medical device. For sterile devices the end of life has been defined, verified and specified with an expiration date. The following general instructions apply to all Orthofix products: • All instruments and product components must be visually inspected under good light for cleanliness. If some areas are not clearly visible, use a 3% hydrogen peroxide solution to detect the presence of organic residuals. If blood is present, bubbling will be observed. After the inspection, the device shall be rinsed and drained as the instruction given above. • If visual inspection evidences that the device was not properly cleaned, repeat the cleaning and disinfection steps or discard the device. • All instruments and product components must be visually inspected for any signs of deterioration that may cause failure during use (such as cracks or damage to surfaces) and functions tested before being sterilized. If a component or instrument is believed to be faulty, damaged or suspect, it must NOT BE USED. • Products that show excessive fadind of marked product code, UDI and lot, thus preventing clear identification and traceability, must NOT BE USED. • Cutting instruments must be checked for sharpness. • When instruments form part of an assembly, check assembly with matching components. • Lubricate hinges and moving parts with an oil that does not interfere with steam sterilization as per manufacturer’s instructions before sterilization. Do not use silicone based lubricant or mineral oil. Orthofix recommends the use of a highly purified white oil composed by paraffinum liquidum of food and pharmaceutical grade. As a general preventive action Orthofix recommends following the instructions in the operative technique to avoid damages related to incorrect use. Specific instructions may be available for some product codes. These instructions are linked to the product code and are available in a dedicated Orthofix website. Moreover, it is important to follow the cleaning procedure suggested by Orthofix to avoid damages related to incorrect handling. PACKAGING In order to prevent contamination after sterilization, Orthofix recommends using one of the following packaging systems: a. Wrap in compliance with EN ISO 11607, suitable for steam sterilization, and appropriate to protect the instruments or trays contained from mechanical damage. Orthofix recommends the use of a double wrap constituted of tri laminate non woven fabrics made of spunbond polypropylene and melt blown polypropylene (SMS). The wrap shall be resistant enough to contain devices up to 10kg. In the USA, a FDA cleared sterilization wrap must be used and compliance with ANSI/AAMI ST79 is mandatory. In Europe, a sterilization wrap in compliance with EN 868-2 may be used. b. Rigid sterilization containers (such as Aesculap JK series rigid sterilization containers). In Europe, a container in compliance with EN 868-8 may be used. Do not include additional systems or instruments in the same sterilization container. Every other sterile barrier packaging not validated by Orthofix must be validated by the individual healthcare facility according to instructions from the manufacturer. When equipment and processes differ from those validated by Orthofix, the healthcare facility should verify that sterility can be achieved using parameters validated by Orthofix. Do not include additional systems or instruments in the sterilization tray. Note that sterility cannot be guaranteed if the sterilization tray is overloaded. The total weight of a wrapped instrument tray should not exceed 10kg. STERILIZATION Steam sterilization according to EN ISO 17665 and ANSI/AMMI ST79 is recommended. Gas plasma, dry heat and EtO sterilization MUST BE avoided as they are not validated for Orthofix products. Use a validated, properly maintained and calibrated steam sterilizer. The steam quality must be appropriate for the process to be effective. Do not exceed 140°C (284°F). Do not stack trays during sterilization.

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Sterilize by steam autoclaving, utilizing a fractioned pre-vacuum cycle or gravity cycle according to the table below: Steam sterilizer type

Gravity

Pre-vacuum

Pre-vacuum

Pre-vacuum

Notes Minimum exposure Temperature Minimum exposure Time Drying Time Number of pulses

Not for use in EU 132°C (270° F) 15 minutes 30 minutes N/A

132°C (270°F) 4 minutes 30 minutes 4

Not for use in US 134°C (273°F) 3 minutes 30 minutes 4

WHO guidelines 134°C (273°F) 18 minutes 30 minutes 4

Orthofix recommends always using a pre-vacuum cycle for steam sterilization. The Gravity cycle was validated but it is suggested only when no other options are available. The Gravity cycle was not validated for sterilization in rigid containers but only in wraps. CLEANING AGENT INFORMATION Orthofix used the following cleaning agents during validation of these processing recommendations. These cleaning agents are not listed in preference to other available cleaning agents which may perform satisfactorily: • For manual precleaning: Neodisher Medizym concentration 2% • For manual cleaning: Neodisher Mediclean concentration 2% • For automated cleaning: Neodisher Mediclean concentration 0,5% STORAGE Store the sterilized instrument in the sterilization packaging in a dry and clean environment at room temperature. DISCLAIMER The instructions provided above have been validated by Orthofix srl as being a true description for (1) processing a single-use device and a multiple use device for its first clinical use and (2) processing a multiple use device for its re-use. It remains the responsibility of the reprocessing officer to ensure that the reprocessing, as actually performed using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process. The cleaning, disinfection and sterilization processes must be adequately recorded. Any deviation by the reprocessing officer from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences, and must also be appropriately recorded. ADDITIONAL INFORMATION INFORMATION FOR THE PATIENT The HCP shall inform the patient that the medical device does not replicate a normal healthy bone and counsel him/her about the correct behavior after implantation: the patient must pay attention to premature weight bearing, load carrying and excessive activity levels. The HCP shall inform the patient about should read of any known or possible restrictions regarding the exposure to reasonably foreseeable external influences or environmental condition and in undergoing specific diagnostic investigations, evaluation or therapeutic treatment after implantation. The HCP shall inform the patient about should read of the need of periodical medical follow-up and of the removal of the medical device in the future. The HCP shall warn the patient about the surgical and residual risks and make him/her aware of possible adverse events. A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the medical device. The HCP shall instruct the patient: - to report any unusual changes to the operative site or in device performances to his/her physician - to report any adverse or unanticipated events - regarding the use and maintenance of the fixator and care of the screw/wire sites. NOTICE ABOUT SERIOUS INCIDENTS Any serious incident occurred in relation to the device should be reported to Orthofix Srl and the competent authority of the Member State in which the user and/or patient is established. MANUFACTURER CONTACT Please contact your local Orthofix sales representative for further details and ordering. ORTHOFIX IS ONLY RESPONSIBLE FOR SAFETY AND EFFECTIVENESS FOR THE SINGLE USE OF THE IMPLANTABLE DEVICES. The institution or practitioner bears full responsibility for any subsequent use of these devices. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Symbols presented below may apply or not to a specific product: refer to its label for applicability.

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Description

Symbol

Medical Device Consult instructions for use or consult electronic instructions for use

Caution: Consult instructions for use for important cautionary information

Single Use. Do not re-use. Orthofix note: discard appropriately after use (treatment) on patient STERILE. Sterilized by irradiaton NON-STERILE Double sterile barrier system Catalogue number

Batch code Expiry date (year-month-day)

0123

CE marking in conformity to applicable European Medical Devices Directives/Regulations Date of manufacture

Manufacture

Do not use if package is damaged and consult instructions for use Caution: Federal law (USA) restricts this device to sale by or on the order of a physician Unique Device Identifier

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