FIELDORTHOPAEDICS
Micro Screw System Instructions for Use
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patients with certain metabolic diseases. All applications that are not defined by the indications are contraindicated. In addition, surgical success can be adversely affected by:
FO MICRO SCREW SYSTEM
FO Micro Screw Kit
FO Pin and K-wire Kit
Instructions for Use Before Using Product This booklet has been made to assist in using the Field Orthopaedics Micro Screw System. It should not be used as a reference for surgical technique. Caution US Federal Law restricts this device to sale and use by, or on the order of, a physician. A. General Description The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO K-Wire Kit. The Field Orthopaedics Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 22 mm in 1 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw. The FO Pin and K-Wire Kit includes 0.6 and 0.8 mm double trocar K-wires of length 70 mm, 1.0 and 1.2 mm double trocar K-wires of length 150 mm, and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion. Accompanying the FO Micro Screw System is the FO 0.6 Pin Collet Insert (compatible with Stryker Pin Collet Adaptor 4100-126), which can be used to aid the insertion of 0.6 mm K-wires where no compatible power tool is available. Implant Materials All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136). All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138). The instrumentation is made from medical grade stainless steel, anodized aluminium and marked with epoxy resin. Refer to the package label for the materials. B. Indications For Use The Field Orthopaedics Micro Screw System consists of the following kits with the following indications: The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm. The FO Pin and Wire Kit is intended for fixation and stabilization of bone fractures or as guidance at insertion of implants into the skeletal system. CE Marked Regions Indications for Use* The Field Orthopaedics Micro Screw System consists of the following kits with the following indications in CE Marked Regions: The FO Micro Screw Kit is intended for fixation of fractures and osteotomies of small bones in the foot and hand. The FO Pin and Wire Kit is intended for fixation and stabilization of bone fractures or as guidance at insertion of implants into the skeletal system. *Note: The limited indications only should be considered for the use of the FO Micro Screw System in CE marked regions. C. Contraindications Use of the Field Orthopaedics Micro Screw System is contraindicated in; cases of inflammation, cases of active or suspected sepsis / infection and osteomyelitis; or in
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1. Acute or chronic infections, local or systemic 2. Vascular, muscular or neurological pathologies that compromise the concerned extremity 3. All concomitant pathologies that could affect the function of the implant 4. Osteopathies with reduced bone substance that could affect the function of the implant 5. Any mental or neuromuscular disorder that could result in an unacceptable risk of failure at the time of fixation or complications in post-operative treatment 6. Corpulence; an overweight or corpulent patient can strain the implant to such a degree that stabilization or implant failure can occur* 7. Known or suspected sensitivity to metal 8. Whenever the use of the implant comes into conflict with the anatomical structures of physiological status *Corpulence is not considered a contraindication in CE marked regions Other medical or surgical pre-conditions that could compromise the potentially beneficial procedure, such as: 1. The presence of tumors 2. Congenital abnormalities 3. Immunosuppressive pathologies 4. Increased sedimentation rates that cannot be explained by other pathologies 5. Increased leukocyte (WBC) count 6. Pronounced left shift in the differential leukocyte count D. Potential Complications and Adverse Reactions In any surgical procedure, the potential for complications and adverse reactions exist. The risks and complications with these implants include: 1. Loosening, deformation or fracture of the implant; 2. Acute post-operative wound infections and late infections with possible sepsis; 3. Thrombosis and embolism; 4. Wound hematoma and delayed wound healing; 5. Temporary and protracted functional neurological perturbation; 6. Tissue reactions as the result of allergy or foreign body reaction to dislodged particles; 7. Corrosion with localized tissue reaction and pain; All possible complications listed here are not typical of the Field Orthopaedics Micro Screw System but are in principle observed with any implant. Promptly inform Field Orthopaedics as soon as complications occur in connection with the implants or surgical instruments used. In the event of premature failure of an implant in which a causal relationship with its geometry, surface quality or mechanical stability is suspected, please provide Field Orthopaedics with the extracted implant(s) in a cleaned, disinfected and sterile condition. Field Orthopaedics cannot accept any other returns of used implants. It is the responsibility of the surgeon to ensure patients have adequate post-operative management. Surgeon’s postoperative care instructions must be strictly adhered to by the patient to avoid adverse loads on the implant/s that may lead to loosening, migration, or failure of the implant. In the case of complications, it might be necessary to remove the implants. For removal follow the surgical technique using the indicated screwdriver. Make sure that the screwdriver/screw head connection is precisely aligned in the axial direction. 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 E. Warnings and Precautions 1. Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure. If corrective action is not taken, complications may occur. 2. Use of an undersized screw in areas of high functional stresses may lead to
Instructions for Use
implant fracture and failure; 3. Plates and screws, wires, or other appliances of dissimilar metals should not be used together in or near the implant site; 4. The FO Micro Screws, FO Pins and K-Wires, and FO drill bits are intended for single use only; Re-use may cause product failure and could lead to disease transmission. 5. Instruments, guide wires and screws are to be treated as sharps; 6. Do not use other manufacturer’s instruments or implants in conjunction with the Field Orthopaedics Micro Screw System. F. MRI Safety Information These devices have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration or image artefact in the MR environment. The safety of the Field Orthopaedics Micro Screw System in the MR Environment is unknown. Scanning a patient who has these devices may result in patient injury. G. Maintaining Device Effectiveness 1. The surgeon should have specific training, experience, and thorough familiarity with the use of screws, fixation pins and wires. 2. The surgeon must exercise reasonable judgment when deciding which screw type to use for specific indications. 3. Field Orthopaedics Micro Screw System is not intended to endure excessive abnormal functional stresses. 4. Field Orthopaedics Micro Screw System is intended for temporary fixation only until osteogenesis occurs. 5. The FO Micro Hex Driver should be replaced after 10 insertions or sub-optimal engagement to the screw is observed. 6. Failure to use dedicated, unique Field Orthopaedics Micro Screw System instruments for every step of the implantation technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury. Failed devices may require re-operation and removal. 7. Carefully inspect the screws, fixation pins and wires prior to use, inspect the instruments before and after each procedure to assure they are in proper operational condition. Instruments which are faulty, damaged or suspect should not be used. 8. Field Orthopaedics recommends the use of Field Orthopaedics products in a sterile environment. H. Cleaning & Decontamination Before being used for the first time and each use thereafter (if reusable), all devices and instruments must be cleaned using established hospital methods before sterilization and introduction into a sterile surgical field. The instructions outlined below should be followed to ensure safe handling of biologically contaminated instruments. Compliance is required with the manufacturer’s user instructions and recommendations for chemical detergents. It is the user’s responsibility to ensure that: 1. The implants and instruments are completely sterile when used; 2. User sterilizers and sterilization processes are validated according to applicable Standards, regularly serviced and inspected, including all instruments and accessories used in combination, according to manufacturer’s specifications; 3. Manufacturer’s recommended parameters are maintained for each cycle. Refer to the Field Orthopaedics document RPIN00001 Reprocessing Instructions for validated, in-depth cleaning, disinfecting, and sterilization instructions. Download the most up-to-date version available at www.fieldorthopaedics.com/brochures. Point of Use The cleaning of instruments should begin at the point of use and continue during the surgical procedure to prevent drying of blood, soil, and debris on the surface and within lumens. 1. The instruments should be kept free of debris and blood during the surgical procedure. If possible, the instruments should be wiped clean using a sterile, water-moistened sponge. Care must be taken that the sponge is not used on the tissues of the patient. 2. Instruments with lumens should be cleared using the Field Orthopaedics cleaning stylet and flushed with a sterile, water-filled syringe to remove blood and debris
Issuance Date: 2021-05-20
and prevent drying of the gross soil. 3. Instruments that may not be used for the remainder of procedure must be immediately soaked in a basin containing sterile water. 4. Prolonged exposure to saline should be avoided to minimize the potential for corrosion. Pre-Soaking Pre-soak the instruments with an enzymatic solution, such as Enzol® by Advanced Sterilization Products®, for a minimum of 1 minute to moisten and loosen the soil, thus making the cleaning step more efficient. Rinse thoroughly to ensure the removal of any potentially harmful residue from the soaking solution. When pre-soaking the instruments, refer to the solution manufacturer’s written instructions for the correct dilution, temperature, and soak time. Sorting and Disassembling Upon arrival in the decontamination area, remove the contaminated items from their transport containers and prepare for cleaning. Check all instruments for damage and corrosion prior to cleaning. If a component is lost, damaged, or corroded, contact Field Orthopaedics directly or your local representative for a replacement. If the device consists of more than one component, and designed to be disassembled, this device must be disassembled prior to cleaning and disinfection. Keep non-interchangeable components of assemblies together to ensure correct reassembly. Cleaning For reusable medical devices, the most important step in decontamination is thorough cleaning and rinsing. Cleaning primarily removes rather than kills microorganisms. The factors that contribute to cleanliness are: 1. Quality of water; 2. The quality, concentration, and type of cleaner; 3. Washing method; 4. Rinsing and drying; 5. Preparation of the contaminated devices; 6. The time, temperature, load capacity of the equipment being used and; 7. Operator performance. Many types of soil could be present on a device, but dried blood is especially difficult to remove. As a liquid, blood tends to flow over and into joints, hinges, grooves, and other difficult-to-clean locations. It then coagulates and dries to create a significant challenge to clean. It must be rehydrated and then washed. When using ultrasonic cleaning, to prevent coagulation do not exceed temperatures of 140°F (60°C) and conduct for a period of 10 minutes. Instruments are optimally cleaned in water and detergent solutions at temperatures between 80°F and 110°F (27° to 44°C), but not to exceed 140°F (60°C). When cleaning instruments, use a brush, cloth, or sponge, and a low foaming, pH neutral detergent solution, such as Renu-Klenz™, or equivalent. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to textured areas, crevices, blind holes, hinges, joints, and cannulated parts. When cleaning an articulating instrument, fully immerse the instrument in the detergent and remove traces of blood and debris with a soft bristle brush. If the instrument can be articulated, retract and open the instrument in the detergent repeatedly. Heavy instruments should not be placed on top of delicate instruments and small components should be placed in baskets. Rinse components under warm or hot flowing water for at least one minute, with direct contact of each surface for a minimum of 10 seconds. Repeat this step using purified water. Dry the internal areas of instruments using compressed air. When drying instruments with concave features, place the concave surface down to facilitate draining. Cleaning Verification 1. Inspect all instruments before sterilizing to ensure the complete removal of all soil from surfaces, tubes, holes, and moveable parts. The ANSI/AAMI ST79 acceptance standard for cleanliness is visibly clean.
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2. Some surfaces of an instrument can be visually obstructed which prevents this verification. If a borescope is not available for inspection, checking for blood can be accomplished by immersing or flushing the instrument in a 3% hydrogen peroxide solution. If bubbling is observed then blood is present and cleaning must be repeated. 3. Rinse instruments thoroughly after using hydrogen peroxide solution. I. Sterilization and Handling All Field Orthopaedics Micro Screw System implants and instruments are supplied CLEAN and NONSTERILE and MUST be sterilized prior to use. Field Orthopaedics recommends the use of steam autoclave (moist heat) sterilization using a pre-vacuum (forced air removal) cycle after removal of all protective packaging and labelling. Instruments shall be sterilized in the mounting condition as stored on the tray (i.e. if the brackets or recessions in the tray are designed to accommodate multi-component instruments in their assembled state) there is no need to disassemble these instruments for sterilization. The use of an FDA cleared sterilization wrap, such as the KimGuard® Sterilization Wrap, is recommended. DO NOT stack the FO Micro Screw Kit and FO Pin and K-wire Kit carry trays. Instruments that do not have a designated place in FO supplied trays can be placed in a standard sterilisation tray as per local sterilisation procedure for loose tools and accessories. Autoclaves should comply with the requirements of, and be validated, maintained and checked in accordance with EN 285/EN 13060, EN ISO 17665, and ANSI AAMI ST79. Method*
Moist heat sterilization according to EN ISO 17665 and ANSI/AAMI ST79
Cycle Type
Pre-Vacuum (Pre-Vac)
Cycle Temp.**
132°C-138°C (270°F-280°F)
Exposure Time**
3-4 minutes Exposure time can be extended to 18 minutes to comply with the recommendation from World Health Organization (WHO), Robert Koch Institute (RKI) etc.
Dry Time*
40 minutes (minimum, in chamber)
Cool Time
60 minutes (minimum, at room temperature)
*Field Orthopaedics has validated the above sterilization cycle per ISO17665-1 and has the data on file.The validated sterilization parameters meet the minimum requirements per AAMI ST79. Other sterilization cycles may also be suitable; however individuals or hosptials not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. **The worst case autoclave cycle has been validated by FO as being capable of achieving sterile medical devices; however autoclave design and performance can affect the efficacy of the process. Healthcare facilities should validate the process that they use, employing the actual equipment and operators that routinely process the devices. ***The drying time varies due to load configuration, wrapping method and material. It is the hospital ́s responsibility to validate the appropriate drying time with the sterilization equipment used.
The following Field Orthopaedics Micro Screw System implants and instruments are for SINGLE USE ONLY, and not reusable: - ALL FO Micro Screws, FO Pins and Wires and FO Micro Drill bits. The following Field Orthopaedics Micro Screw System instruments are reusable: - FO Micro Driver bits, FO Micro Countersink bits, FO Guide Sleeves, FO Soft Tissue Protector FO Pin Collet Insert, FO Micro Depth Gauge, FO Micro Cleaning stylet, FO Surgical Handle and FO Micro Screw Kit Tray and Lid. The epoxy coated components of the Field Orthopaedics Micro Screw System have been validated to be safe for up to 10 sterilization cycles. Field Orthopaedics cannot guarantee the safety and efficacy of the components past this limit. J. Receival, Inspection & Functional Testing Upon receival, Field Orthopaedics recommends that the kits be inspected for damage and dislodgement of any individual parts fo the system. Any implants or instruments in the kit found to be damaged or displaced during transport should be discarded and replacements ordered. The rejected goods must be returned to Field Orthopaedics Pty Ltd. or their distribution partner within ten working days. Instruments should be inspected for damage and wear before use. Check for smooth movement of assemblies without excessive play. Locking mechanisms should attach and detach easily. Cutting edges should be free of nicks and have a continuous edge.
Instructions for Use
Long slender instruments should be straight and free of distortion. End of functional life is normally determined by wear and damage due to use. K. Packaging Field Orthopaedics devices should be accepted only if the factory packaging and labelling arrive intact. Contact Customer Service if the package has been opened or altered. L. Surgical Technique Field Orthopaedics Micro Screws, Pins and K-Wires should only be implanted by surgeons who are fully experienced in the use of such implants and the required specialized surgical techniques. Surgeons are advised to review the product specific surgical technique prior to performing any surgery. Field Orthopaedics provides detailed surgical techniques in print and electronic formats. Refer to the Field Orthopaedics document STC00001 Product Leaflet and Surgical Technique for the illustrated surgical technique. Download the most up-to-date version available at www.fieldorthopaedics.com/brochures. M. Storage Conditions. Store away from moisture and direct heat. N. Product Complaints The customer or health care provider should report any dissatisfaction with the product quality, labelling, or performance to Field Orthopaedics immediately. Field Orthopaedics should be notified immediately of any product malfunction by telephone or written correspondence. When filing a complaint, the name, part number and lot number of the part should be provided along with the name and address of the person filing the complaint. Please contact Field Orthopaedics for product enquiries, cleaning instructions and surgical techniques, or to report any adverse event. Symbols All symbols shown may not apply to this device. Please refer to the package labelling for utilized symbols. Not to be used if package is damaged
Non sterile
Catalogue number
Lot number
Manufacturer
Manufacture date
Authorised Representative in the European Community
Caution: Federal Law (USA and Canada) restricts this device to sale by or on the order of a physician
Consult eIFU
Do no reuse
The product meets essential requirements of Medical Device Directive 93/42/EEC for Risk Class I medical devices, non sterile, I with measuring function, IIa and IIb.
The product meets essential requirements fo Medical Device Directive 93/42/EEC for Risk Class I medical devices, non sterile, without measuring function.
www.fieldorthopaedics.com/brochures
Authorised Representative Advena Ltd. Tower Business Centre, 2nd Flr., Tower Street Swatar BKR 4013 Malta Manufacturer Field Orthopaedics Pty. Ltd. 30 Florence Street Teneriffe 4005 QLD Australia [email protected] www.fieldorthopaedics.com This document is subject to continuous revision. Please verify that the current printed version is identical to the one at www.fieldorthopaedics.com/brochures.
Issuance Date: 2021-05-20