jri Orthopeadics

JRI Instrumentation Sterile and Non-Sterile Instructions for Use

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JRI ORTHOPAEDICS LTD 18 Churchill Way, 31A Business Park, Chapeltown, Sheffield, S35 2PY, UK Instructions for Use JRI Instrumentation – Sterile & Non-Sterile IFU 155-024 Iss.11 April 2020 Page 1 of 74

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JRI ORTHOPAEDICS LTD 18 Churchill Way, 31A Business Park, Chapeltown, Sheffield, S35 2PY, UK

Instructions for Use

JRI Instrumentation – Sterile & Non-Sterile

IFU 155-024 Iss.11 April 2020

Page 1 of 74

JRI Instrumentation – Sterile and Non-Sterile English

Important Information Further reprocessing information for JRI reusable instrumentation is available in document F403O, External Instrument Sterilisation Instruction. Please read instructions for use and corresponding operative technique, prior to use in a clinical setting. The Surgeon should be familiar with the appropriate operative technique. Material(s)

Standards

Titanium Alloy

Ti6Al4V

ISO 5832-3

Stainless Steel

ISO 5832-9

Cobalt Chrome Alloy

CoCr

ISO 5832-4

Ultra-High Molecular Weight Polyethylene

UHMWPE

ISO 5834-2

Cross-linked Ultra-High Molecular Weight Polyethylene

XL-UHMWPE

ISO 5834

Radel, Acetal, Tufnol, Silicone, Nylon 66, PEEK, TPE, PTFE

ISO 16061

Aluminium Nickel/Diamond

ISO 5892:1 -

Caution: Contains Cobalt Abbreviations and Definitions 12/14 = 12mm Small taper diameter, 14mm Large taper diameter LS = Long Spigot. < = Angle AF = Across Flats For Trial Stems: XXS = Extra Extra Small. XS = Extra Small. S = Small. M = Medium. L = Large. XL = Extra Large For Trial Heads Neck lengths: S = Short. M = Medium. L = Long. XL = Extra Long XL+4 = Extra Long plus 4mm. XL+8 = Extra Long plus 8mm Intended Use JRI Sterile and Non-Sterile Instrumentation is intended for use during joint replacement surgery to facilitate both the insertion, fixation and removal of implantable devices. Information regarding suitability for re-use and sterility is provided on the device label. Treatment Population JRI Sterile and Non-Sterile Instrumentation is designed for use in skeletally mature individuals undergoing hemior total, primary or revision joint replacement surgery. JRI Sterile and Non-Sterile Instrumentation consists of non-active devices and their accessories for transient use in orthopaedic surgical procedures implanting JRI products only. Description Non-Sterile, Reusable Instrumentation The range includes Class I manual surgical instruments, and Class IIa (93/42/EEC) surgical instruments that can be used either under power, or as trial components. These are reusable and are supplied non-sterile, for sterilisation prior to use by the end user.

IFU 155-024 Iss.11 April 2020

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JRI Instrumentation – Sterile and Non-Sterile English

Sterile, Single-Use, Instruments Single-use instruments are supplied sterile, as indicated by means of approved symbols on the outer labels of the packaging, and have been sterilised by exposure to a minimum 25 kGy of gamma-radiation. Single Use instruments may be used multiple times within a single procedure, if required, on a single patient, but must NOT be resterilised, or reused, as reprocessing may not provide adequate sterilisation, and/or initial use, or reuse, may compromise the functionality and efficacy of the instrument (e.g. blunting of cutting edges, or distortion or misalignment of component parts). If the sterile barrier of the packaging is broken, and a single use instrument is not used, then it cannot be resterilised or used for a subsequent operative procedure. Note JRI Instrumentation has been designed and manufactured for use with specific JRI Orthopaedic implant systems. The instrumentation should only be used with other JRI compatible components. Instrument assemblies should only contain compatible components with corresponding connections. Instrumentation components from one manufacturer should not be used together with those of another manufacturer, since compatibility of mating parts cannot be assured. Indications This instrumentation is to be used only under the control and supervision of an accredited Orthopaedic Surgeon or Physician whose responsibility it is to ensure that any user is qualified and trained in the use of these surgical instruments and the relevant surgical procedures. The medical team have a duty of care towards their patient which includes the correct use of this instrumentation. As a manufacturer of the product, JRI take no responsibility for any damage, breakage or adverse affects caused as a result of any failure in the medical team to discharge such duty. Contra-indications This instrumentation should not be used: • • • •

where there is active infection by untrained, or inexperienced persons, or persons who are not clinically qualified to carry out the procedure for which the instruments are intended For clinical procedures for which they are not intended. if they are visibly broken, or damaged intra-operatively, or fail to function as intended due to incorrect assembly

Pre-operative Clinicians should familiarise themselves with the instrumentation, prior to clinical use, particularly where that instrumentation requires intra-operatively assembly. The surgeon should discuss all aspects of the surgery with the patient. Allergies and other reactions to instrument materials although rare should be considered and ruled out pre-operatively. X-ray templates should be used to estimate implant sizes, placement and joint alignment. Pre-operative preparation of Instruments Single-use instruments are supplied sterile, and do not require cleaning, or sterilisation, prior to use. For non-sterile, reusable instrumentation, all packaging should be removed prior to decontamination and sterilisation, in accordance with JRI document F403O. These instruments are to be decontaminated by soaking/scrubbing/ultrasonic clean and auto-wash/disinfect before being sterilised to an approved, validated, method for medical devices; (BS EN ISO 17665-1 - by moist heat (1340C - 1370C for a minimum of 3 minutes) is recommended) and shall be maintained in a sterile state until used. IFU 155-024 Iss.11 April 2020

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JRI Instrumentation – Sterile and Non-Sterile English

Prolonged immersion in a disinfecting solution can damage surgical instruments and should NOT be soaked for a long period of time. Immediately after cleaning/rinsing, the instruments should be dried. After autoclaving, all instruments must be allowed to cool and dry thoroughly. The amount of dry-time required is dependant upon the load size and its mass. The instruments should be placed on a shelf with a linen cover until cooling is complete. The potential for condensation may increase if the case is not allowed to cool properly. Sterilisation by chemical means or higher temperatures should not be used as these could adversely affect the materials used. The adequacy of any sterilisation procedure should be developed and tested only by trained personnel. All instrumentation should be thoroughly inspected for possible damage prior to surgery. The surgical staff should ensure that all reusable instrumentation has been adequately sterilised, using an approved, and validated, cleaning and decontamination process, and has been correctly reassembled prior to use, and is fit for purpose. For more complicated instrumentation, specific assembly Instructions are provided, and should be consulted. Intra-operative Care should be taken not to cut through surgical gloves when handling any sharp-edged instruments and to take into account the risk of infection if a cut appears. The recommended operative technique for a specific procedure, and use of the corresponding instrumentation is provided by JRI Orthopaedics, and is available on request. The operative technique describes the correct use of the instrumentation and its use in combination with other instruments and implantable devices, and, if applicable, restrictions in the use of that instrumentation. Competitor instruments should not be used in direct combination with JRI instrumentation, where they might influence the positioning, alignment, or placement of the respective JRI implants. The surgeon is responsible for ensuring optimum implantation of the prosthetic device using this Instrumentation, and should also refer to the relevant implant Instruction for Use. Reasonable, but NOT excessive, force may be required in the use of this instrumentation. Where a specific force or torque is required, this is indicated in the operative technique. Extra care and cautions should be applied when using Class IIa instruments. As the manufacturer, JRI Orthopaedics Ltd can take no responsibility for damage, breakage or other adverse effects caused as a result of the failure of any person to follow these instructions or any other relevant applicable JRI instructions. Post-operative If the instrumentation is not fully intact or complete after the operation, then the surgeon should be adequately convinced that no parts are left in vivo. Fragments of instruments may be located by means of an image intensifier and/or X-ray radiography. It is the responsibility of the surgical staff to ensure that all instrumentation is thoroughly cleaned and decontaminated as soon as possible after use. Damaged instrumentation should be reported to your local JRI Sales Representative and return to JRI Orthopaedic Ltd. for investigation. Adverse effects Bone fractures may result from one-sided overloading or weakening of the bone substance. There may also be a risk of cardiovascular disorders, tissue reactions and haematoma. The surgeon is responsible for any

IFU 155-024 Iss.11 April 2020

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JRI Instrumentation – Sterile and Non-Sterile English

complications that may result from erroneous indication, incorrect operative technique or inadequate aseptic precautions. Cleaning / decontamination instructions apply. Patients identified as risk patients with regard to Creutzfeldt-Jakob disease (CJD), related infections or other unusual transmissible diseases should be treated with single use instruments, which are disposed after surgery. Because of insufficient scientific evidence available today, a general efficient cleaning and decontamination procedure cannot be recommended. Current national recommendations should be considered. Surgical instrumentation must be neither treated mechanically, nor modified, unless this is required by the design. Post-operative Decontamination Sterile, Single-Use instruments must not be resterilised, but be disposed of, in accordance with the corresponding hospital procedure for such components, following the completion of the surgical procedure. Non-sterile, reusable instruments should be decontaminated immediately after use in accordance with F403O. Foreign debris should be removed with a disposable cloth or paper wipe, at point of use. If instruments have been exposed to blood, tissue, saline or other foreign matter they must be rinsed in warm (not hot) water before these substances are allowed to dry. Both physical and chemical processes are necessary to minimize the bioburden on all soiled items. Chemical (detergent) alone cannot remove all debris and a careful manual cleaning of each item is essential for maximum decontamination. JRI recommend the use of a mild pH neutral detergent. Once items have been cleaned and decontaminated they should be thoroughly rinsed with distilled water to remove any detergent before sterilisation. Placing instruments on top of one another and the mixing of dissimilar metals should be avoided. Any instrument that can be dismantled should have the various components cleaned separately, in accordance will the specific cleaning instructions provided with theses instruments. Attention should be paid to any cannulated instrument and any screw holes where debris may enter before being re-assembled. Recesses and hidden areas within an instrument should be inspected regularly to ensure that entrapped or other residual materials are completely removed. If the instrument requires a complicated assembly technique then refer to the additional assembly/dis-assembly instructions. Lubrication oil is not required and should not be used on these instruments. Where cleaned and decontaminated reusable instruments are to be returned to JRI, the appropriate decontamination certificate, F403O, shall be completed by the Theatre Manager or their authorised Deputy Storage & Handling Instrumentation should be stored in their original protective packaging in a clean and dry atmosphere. This recommendation is equally valid for the transport and packaging of surgical instruments. Reusable Instruments may be loaded into instrument trays or general purpose sterilization trays and should be wrapped using a double wrap method. The acceptable storage period depends on the storage conditions, which must be determined by the Hospital. Surgical instruments are sensitive to damage. Even small scratches can increase wear and the risk of corrosion. Instruments should be handled with care at all times. Care should be taken when lifting complete instrument sets or transit cases. Instrument Shelf-life

IFU 155-024 Iss.11 April 2020

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JRI Instrumentation – Sterile and Non-Sterile English

Non-sterile, reusable, instruments do not have a shelf-life, as they are manufactured from materials that do not deteriorate over time, under ambient storage conditions. The shelf-life of sterile, single-use, instruments is indicated on the corresponding labelling for that instrument. Functional Device Lifespan The functional lifespan of reusable instrumentation is dependent on, amongst other things, the level and degree of use. The cutting edges of sharp instruments should be maintained and replaced at the surgeons’ discretion. Repeated processing has minimal effect on instruments. All instruments should be visually inspected for damage and wear prior to use, and, where appropriate, reported to JRI Orthopaedics Ltd, for reprocessing, or replacement. Products intended for single-use must not be re-used Re-use or reprocessing (e.g. cleaning and re-sterilisation) may compromise the structural integrity of the device and / or lead to device failure which may result in patient injury or death. Reuse or reprocessing of single-use devices may create a risk of contamination (e.g. transmission of infectious material) which may result in injury or death. Further information For product specific operative technique training or further information, please contact your JRI Orthopaedics Ltd. Sales Representative or JRI Orthopaedics Ltd. directly.

JRI ORTHOPAEDICS LTD 18 Churchill Way, 35A Business Park, Chapeltown, Sheffield, S35 2PY, UK Tel: +44(0)114 345 0000 Fax: +44(0)114 345 0004 www.jri-ltd.co.uk