DePuy Synthes
AGILITY LP +1 POLY TRIAL SIZE 1
Non-sterile Reusable Instruments, Instruments Trays and Cases Instructions for Use
117 Pages
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IFU-0902-60-002 Rev. B
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en
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*Refer to label for CE mark and identification number of the notified body responsible for conformity assessment (if applicable).
Non-sterile Reusable Instruments, Instruments Trays and Cases IMPORTANT INFORMATION – Please read before use Some products may not be licensed in all jurisdictions.
For access to the e-IFU and any additional languages visit www.e-IFU.com. These instructions apply to the instruments in the following brands: ACTIS™, AML™ EXCEL™, ARTICUL/EZE™, ATTUNE®, ATTUNE® KNEE SYSTEM, CORAIL®, CORAIL® AMT, CORAIL® Revison, C-STEM®, C-STEM® AMT, DEPUY ORTHOPAEDIC INSTRUMENTS, DURALOC®, DURALOC® Bantam, DURALOC® OPTION, LCS™ Completion, LPS™, M.B.T., M.B.T. PATHWAY, M.B.T. REVISION, M.B.T./LCS® COMPLETION, M.B.T./P.F.C.™ SIGMA® RP, MARATHON®, MARATHON® XLPE, MITKR CAS, MULLER, P.F.C.® SIGMA® LCS COMPLETE™, P.F.C.™, P.F.C.™ Σ, P.F.C.™ SIGMA®, P.F.C.™ SIGMA® High Performance, P.F.C.™ SIGMA® RPF® High Performance, P.F.C.™ SIGMA® SPECIALIST™ 2, P.F.C.™/ULTIMA™, PINNACLE®, PINNACLE® Bantam, PINNACLE® ES3®, PINNACLE® GRIPTION® TF, PROFILE, QUICKSET™, RECLAIM™, SELF CENTERING, SIGMA®, SIGMA® HIGH PERFORMANCE, SIGMA® HP, SIGMA® LCS™ HIGH PERFORMANCE, SIGMA® RP, SMARTSET™, SOLUTION SYSTEM™, SP2, SPECIALIST™, SPECIALIST™ 2, SPECIALIST™ P.F.C.™, S-ROM®, S-ROM® NOILES™, SUMMIT®, TISSUE SPARING SOLUTIONS, TRI-LOCK® BPS W/GRIPTION™, TRUMATCH®, UNI-ROM.
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INTENDED USE / INDICATIONS / CONTRAINDICATIONS / PATIENT POPULATION / INTENDED USER
Instruments are supplied NON-STERILE
These instructions apply to the non-sterile reusable instruments associated with the systems listed above. The devices are intended to enable implantation of DePuy Synthes prostheses. These are intended for reprocessing in a health care facility setting. No direct clinical benefit is expected from these devices as this benefit is expected to be derived from the associated implant. For information relating to indications, contraindications, clinical benefits, and intended patient populations refer to the joint prosthesis instructions for use. Additional information that is specific to these instruments is listed below. • These devices are not to be used by unqualified personnel. • It is essential that the surgeon and operating theatre staff are fully conversant with the appropriate surgical technique for the instruments and associated implant, if any.
MATERIALS & RESTRICTED SUBSTANCES
• For indication that the device contains a restricted substance or material of animal origin see product label.
WARNINGS AND CAUTIONS
• These instruments must be cleaned, inspected and sterilized prior to use. • Do not modify or alter the device unless instructed to do so in the surgical technique guide, the assembly/disassembly instructions, label or processing IFU. • See device reprocessing section for instruments that require specific cleaning instructions
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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• These instruments are not intended for use in a MR environment. They have not been tested for safety and compatibility in the MR environment. The instruments have not been tested for heating or migration in the MR environment. • Ensure that no instruments or parts of instruments are left in the surgical site prior to closure, as patient injury may result. Instruments may not be detectable using imaging techniques e.g. radiograph, CT scan, fluoroscopy.
ADVERSE EVENTS & COMPLICATIONS
SERIOUS INCIDENT REPORTING (EU)
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
DEVICE PROCESSING
• Detailed instructions for processing of reusable devices, instrument trays and cases are described in the DePuy Synthes ‘Instructions for Processing Medical Devices. Reusable Instruments, Instrument Trays and Cases’ IFU. • Part Number 254401005 (Attune Femoral Introducer) must follow Manual Cleaning instructions ONLY. • At the end of the device’s life safely dispose of the device in accordance with local procedures and guidelines. Where further information is desired, please contact your local DePuy sales representative. For instruments produced by another legal manufacturer, reference the manufacturer’s instructions for use.
Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, (c) a serious public health threat; Adverse events to patient (for more information see implant IFU): • Delay to surgery caused by missing, damaged or worn instruments. • Tissue injury and additional bone removal due to blunt, damaged or incorrectly positioned instruments. • Tissue reactions, osteolysis and/or implant loosening caused by metallic corrosion, allergic reactions, wear or particulate debris. • Infection and toxicity due to improper processing. • Damage to vital organs due to sharp instruments. • Neurological damage due to sharp instruments or surgical trauma. • Vascular damage due to sharp instruments or damage. • Cardiovascular disorders i.e. venous thrombosis, pulmonary embolism. Adverse events to user: • Cuts, abrasions, contusions or other tissue injury caused by burs, sharp edges, impaction, vibration or jamming of instruments.
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This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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INTERPRETATION OF SYMBOLS DePUY
Serial Number
Catalogue Number
Caution
Batch code
Remove after reaming
Lift
Right/left
Sharps
Distributed by
Size/ size/ diameter/ inches/ feet/ degrees/ group/ pounds/ outer diameter/ inner diameter
Lubricate Device
MUST USE WITH TIBIAL PROTECTION PLATE
Consult Instructions for Use NON STERILE
e-IFU website
Manufacturer
Non-sterile
Do not use if package is damaged
Separate collection
Packaging unit
EC
MD
Contains EU regulated chemical substance
Contains animal origin Substance
Medical Device
Do not disassemble
Lock
Unlock
LOCK
Cleaning position Identifier on Instrument
Dismantle for cleaning
FORWARD
Rasps for use with T handle only
APEX
NOT FOR USE WITH IMPLANT
Recyclable
REVERSE
Small/large
PRELIMINARY ASSEMBLY INSTRUMENT
RESET TO GREEN
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MUST USE WITH GUIDE SHAFT
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Ireland Tel: +353 214914000 Fax: +353 214914199
Revised 2021/10 © DePuy Synthes 2019-2021. All rights reserved. 2021-10-21 14:46:56
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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