Instruments and Instrument Cases Care and Handling Recommendation

INSTRUCTIONS FOR USE POINT OF USE PREPARATION

Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. The decontamination process should begin immediately after the completion of the surgical procedure. If cleaning must be delayed, place instruments in a covered container with pH Neutral enzymatic detergent to delay drying. Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning. Wash all instruments whether or not they were used or were inadvertently contacted with blood. Disassemble instruments with removable parts; loosen instruments with movable parts, as applicable.

DECONTAMINATION

Decontamination is for the purpose of microbial inactivation. Saturate the surface completely with full strength intermediate disinfectant/cleaner* (e.g. CaviCide) and allow to remain in contact with devices for 5 minutes.

A. MANUAL CLEANING: ALL INSTRUMENTS

1.

2.

3.

Pre-Cleaning: Remove all visible soil by immersing the devices in room temperature neutral pH enzymatic cleaner* (e.g. MetriZyme) and disassemble/loosen instruments, if suitable. The majority of the surgical instruments and trial devices are simply constructed and will not require disassembly. However, some of the more complex instruments are made of several components and these should be disassembled into their individual parts prior to decontamination. Scrub with the appropriate soft bristle brush until visibly clean; actuate through the full range of motion. Washing: Immerse devices in the ultrasonic washer/cleaner with room temperature neutral pH enzymatic cleaner* (e.g. MetriZyme) and sonicate for 10 minutes. Ultrasonic cleaners can be used with hot water per the manufacturers’ recommended temperature; however, room temperature was qualified. Be aware that loading patterns, water temperature, and other external factors may change the effectiveness of the equipment. Rinsing: Thoroughly rinse the devices with deionized or distilled water. For example, a minimum of 2 minutes three (3) times. * Do not use high acidic (pH <4) or high alkaline (pH >10) products for disinfection or cleaning, since these can corrode metal, cause discoloration or stress fractures. DJO Surgical® has qualified the above cleaning method with the provided solution examples, for a 3 Spore Log Reduc tion (SLR). Other cleaning/disinfection methods may also be suitable, however individuals or hospitals not using the recommended method are adv ised to validate any alternate method using appropriate laboratory techniques.

B. MANUAL CLEANING: INSTRUMENTS WITH CANNULAS, LUMENS, OR HOLES

1. 2. 3.

C. MANUAL CLEANING: ARTICULATING INSTRUMENTS

1. 2.

3.

Pre-Cleaning: Follow the “Pre-Cleaning” and “Washing” steps in Section A. Manual Cleaning – ALL INSTRUMENTS. Washing: After ultrasonic cleaning, in a fresh enzymatic cleaning bath use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub any cannula, lumen, or hole(s). Push in and out, using a twisting motion to remove debris. Use a syringe filled with enzymatic neutral pH cleaning solution to flush hard to reach internal areas. Rinsing: Flush the instrument paying special attention to the cannulations, lumens, and/or holes with deionized or distilled water. For example, a minimum of 2 minutes three (3) times. Pre-Cleaning: Follow the “Pre-Cleaning” and “Washing” steps in Section A. Manual Cleaning – ALL INSTRUMENTS. Washing: After ultrasonic cleaning, immerse the instrument in fresh neutral pH enzymatic cleaning solution to avoid aerosol generation. Actuate moveable mechanisms through full range of motion, such as knobs, hinges, box locks, or spring-loaded/retractable features. For instruments with flexible shafts, bend or flex the instrument under the neutral pH cleaning solution while brushing the flexible areas. For instruments with internal cavities, after actuating components in the neutral PH cleaning solution, fully open components and use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub the internal cavities. Use a syringe filled with enzymatic neutral pH cleaning solution to flush hard to reach internal areas Rinsing: Actuate and/or retract moveable parts while rinsing with deionized or distilled water. For example, a minimum of 2 minutes three (3) times. For instruments with flexible shafts, flex the instrument while rinsing.

AUTOMATED CLEANING

DJO Surgical® instruments may be washed and/or disinfected by using an automated washer-disinfection unit utilizing thermal disinfection after completing the manual cleaning methods. Temperatures, cycles, and disinfectant type used should be as instructed by manufacturer of the washer- disinfection unit. For ultrasonic cleaning follow the manufacturer’s specifications for suggested water level and concentration. When using mechanical washers, make sur e the instruments are secured in place within the instrument case with the lid removed, and do not touch or overlap. Automated washer/disinfector systems are not re commended as the sole cleaning method for surgical instruments.

DRYING

Ensure device is dry prior to inspection and sterilization preparation. Instruments must be thoroughly dried to remove residual moisture before they are stored. Filtered compressed air may be used prior to air drying if available.

MAINTENANCE INSPECTION AND TESTING

After cleaning, the instruments (disassembled, if applicable) should be visually inspected. Check for misalignment, burrs, bent, or fractured tips. Mechanically test the working parts (e.g. hinges) to verify that each instrument functions throughout its intended range of motion. Place instruments into appropriate configuration within instrument case and wrap with protective FDA cleared sterilization wrap according to AAMI / AORN guidelines. Surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling. Care must be taken to avoid compromising their performance. To minimize damage, conduct the following: 1. Inspect instrument cases and instruments for damage when received and after each use and cleaning. Incompletely cleaned instruments should be re-cleaned, and those that need repair returned for servicing. 2. Only use an instrument for its intended purpose. 3. When handling sharp instruments use extreme caution to avoid injury. Consult with an infection control practitioner to develop safety procedures appropriate for all levels of direct instrument contact. 4. If instruments appear to be damaged in such a way that may compromise the performance of the instrument, contact your DJO Sur gical® representative for a replacement. 5. Visually inspect the instrument and check for damage and wear, moveable parts should have smooth movement, locking mechanisms should fasten securely

TRANSPORT

Compliance with the general precautionary measures for handling contaminated/biologically hazardous materials is required.

STERILIZATION

Instruments supplied by DJO Surgical® have been thoroughly cleaned, inspected and tested for proper function prior to shipmen t. Unless otherwise indicated, these instruments are NOT STERILE and must be sterilized prior to use. Instruments provided outside of instrument sets should be fu lly loosened/disassembled and wrapped in FDA cleared sterilization wrap per AAMI ST:79/AORN Guidelines. Flash (immediate-use) steam sterilization by exposure at 132°C / 270°F should only be used as an emergency procedure. Instruments must be cleaned and disassembled prior to processing. The following are minimum cycles required for steam sterilization that has been validated by DJO Surgical® under laboratory conditions to achieve a SAL of 10-6 with components loosened or disassembled. DJO Surgical® has data on file. Sterilization with a Pre-Vacuum Sterilizer (HI-VAC): 270° F (132° C), 5-minute exposure time, and a 30-minute dry time. Sterilization with a Gravity Displacement Sterilizer: 270° F (132° C), 30-minute exposure time, with a 30-minute dry time.

STORAGE/INSTRUMENT CARE

PAGE 2 OF 32

Instruments must be thoroughly dried to remove residual moisture before they are stored. Instruments or instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture. Care must be taken in handling wrapped instruments or instrument cases to prevent damage to the barrier. The user must be aware that maintenance of sterility is event-related and that the probability of occurrence of a contaminating event increases over time and with handling

FORM 1000.3004.02 Rev. A

CONTACT INFORMATION

DJO Surgical® ATTN: Customer Service 9800 Metric Boulevard Austin TX, 78758 USA + 1-800-456-8696

2. Product Description The devices covered by this IFU are the instruments used to implant DJO Surgical implantable devices, as well as the instrument cases used to store said instruments for cleaning and transportation. The following devices are covered by IFU 0400-0221 and not this IFU. FA XALT TRIAL (803-99-039) FA FMP INSTRUMENT (803-99-018) FA RSP GLENOID (804-99-11) 3D KNEE GAP BALANCER (S-200775) RSP HALF MOON REAMERS (804-06-012, 804-06-013, 804-06-014) FA K EXPRT REV 1 (800-99-092) FA K EXPRT REV 2 (800-99-093) FA DAA GENERAL (803-99-102) FA DAA RETRACTOR (803-99-103) FA TURON RETRACT (804-99-020) FA TURON HUMERAL STEM 2010 (804-99-117) FA TURON GLENOID 2010 (804-99-118) FA TURON HUMERAL HEAD 2010 (804-99-119) FA RSP HUMERAL (804-99-010) FA RSP GLENOID (804-99-011) FA RSP MONOBLOCK LTD RELEASE (804-99-025) FA RSP SIZE 44 INST (804-99-024) FA K EMP DRF FEM PREP (800-99-094) FA K EMP TIB PREP (800-99-095) FA K EMP PAT TOOL KIT (800-99-096) FA K EMP BONUS KIT (800-99-097) FA K EMP 3D TRL CORE LT (800-99-098) FA K EMP 3D TRL CORE RT (800-99-099) FA S ALTIVATE RSP HUM PREP (804-99-120) FA S ALTIVATE RSP HUM TRLS (804-99-121) FA K EMP 3D TRL PREP OUT SML (800-99-101) FA K EMP 3D TRL PREP OUT LG (800-99-102) FA K EMP INS TRL SPCRS (800-99-103) FA LR FMP CUP INSERTER (803-99-098) FA FMP ACET REAMER (803-99-003) FA XALT INST (803-99-040) FA MIS HIP (803-99-028) FA TAPERFILL INSTRUMENTS (803-99-170) FA TAPERFILL INSTRUMENTS – 7MM (803-99-170 FA TAPERFILL BROACHES (803-99-171) FA H TAPERFILL BROACH 7MM POST (803-99-172) FA TAPERFILL BIG LUG FT BROACH (803-99-172) FA K EMP 3D CR TRL PREP OUT LG FA K EMP 3DCR TRL PREP OUT SML FA K EMP CR TRL CORE LT FA K EMP CR TRL CORE RT FA K EMP PS FEM TRL CAP CORE (800-99-117) FA K EMP PS FEM TRL CORE (800-99-117) FA K EMP PS INS TRL CORE (800-99-118) FA K EMP PS TRL PREP OUT L CAP (800-99-108) FA K EMP PS TRL PREP OUT LG (800-99-108) FA K EMP PS TRL PREP OUT S CAP (800-99-107) FA K EMP PS TRL PREP OUT SML (800-99-107) FA K EMP 3D + CR COMP OUT LG FA K EMP 3D + CR COMP OUT SML FA K EMP 3D COMP OUT LG FA K EMP 3D COMP OUT SML FA K EMP COMP PAT TOOL KIT FA K EMP CR COMP OUT LG FA K EMP CR COMP OUT SML FA K EMP TIB PREP 2 FA S ALTIVATE RSP 44 FA S ALTIVATE RSP HUM TRLS SML FA K EMP CEM STEM AUG PREP FA K EMP TIB PREP COMPLETE FA K EMP PS TRL PREP OUT SML 2 FA K EMP PS TRL PREP OUT LG 2 FA K EMP VVC INS TRL CORE FA S ALTIVATE RSP REVISION FA H EMPOWR ACET GENERAL INST FA H EMPOWR ACET MIS HANDLES FA H EMPOWR ACET TRL NEU 10DH FA H EMPWR ACET OFFSET TR LNRS FA H EMPOWR ACET ANCILLARY FA H EMPOWR ACET GEN INST V2 FA H EMPOWR ACET ANCILLARY V2 FA S ALTIVATE RSP SHORT FA K EMP PARTIAL FA K EMP PARTIAL PREP 1 OF 2 PAGE 3 OF 32

FORM 1000.3004.02 Rev. A

FA K EMP PARTIAL TRIAL 2 OF 2 FA S ALT ANATOMIC CS EDGE FA K EMP FEM PREP - ADJ SZR The following devices are covered by IFU 0400-0248 and not this IFU. FA K EMP PS FEM TRL CAP CORE (800-99-117) FA K EMP PS FEM TRL CORE (800-99-117) FA K EMP PS INS TRL CORE (800-99-118) FA K EMP PS TRL PREP OUT L CAP (800-99-108) FA K EMP PS TRL PREP OUT LG (800-99-108) FA K EMP PS TRL PREP OUT S CAP (800-99-107) FA K EMP PS TRL PREP OUT SML (800-99-107) FA S ALT ANATOMIC HUM STEM (804-99-125) FA S ALT ANATOMIC HUM HEAD (804-99-126) FA S ALT ANATOMIC GLENOID (804-99-127) FA S TURON KEELED GLENOID (804-99-128) FA H EXPRT REV HIP REAMERS (803-99-095) FA H EXPRT REV HIP GENERAL (803-99-096) FA H FMP STR CUP INSERTER (803-99-101) DOUBLE OFFSET BROACH HANDLE, LEFT (803-03-084) DOUBLE OFFSET BROACH HANDLE, RIGHT (803-03-085) FA H HXE NEU-10DH EXTD (803-99-111) 3. Indications Reference the applicable implant IFU for Indications. 4. Intended Use Reference the applicable implant IFU for device Intended Use. 5. Contraindications Reference the applicable implant IFU for Contraindications. 6. Precautions and Warnings Reference the applicable implant IFU for Precautions and Warnings. 7. Preoperative Planning and Postoperative Care Reference the applicable implant IFU for Preoperative Planning and Postoperative Care. 8. MRI Safety N/A 9. Adverse Effects Reference the applicable implant IFU for Adverse Effects. Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the relevant Competent Authority as defined in EU 2017/745. 10. Lifetime of Device DJO Surgical does not define the maximum number of uses appropriate for re-usable instruments. While the expected lifetime of surgical instruments may be subject to a multitude of factors such as patient characteristics, surgeon experience, amount of use, and surgical technique, evaluating the time between the release of an ins trument from production and the return of that instrument to the manufacturer from the user can give an indication of its expected lifetime. Based on this information, Powered Instruments have shown to last as short as 5 days in the field or as long as 9.5 years in the field, with an average lifetime of 2.3 years. Non-Powered Impaction or Extraction Instruments have shown to last as short as 3.5 months in the field or as long as 18 years in the field, with an average lifetime of 2.8 years. Non-Powered Guide Instruments have shown to last as short as 35 days in the field or as long as 9.1 years in the field, with an average lifetime of 2.9 years. Non-Powered, Non-Impaction/Extraction, & Non-Guide Instruments have shown to last as short as 56 days in the field or as long as 9.3 years in the field, with an average lifetime of 3.5 years. As product data continues to be collected, these lifetime estimates may be re-evaluated and adjusted if required. Users should note that careful inspection of the instrument before use is the best metho d of determining the end of serviceable life. 11. Trademarks and Patents Reference the applicable implant IFU for Trademarks and Patents.

PAGE 4 OF 32

FORM 1000.3004.02 Rev. A

FA K EMP 3D TRL PREP OUT LG (800-99-102) FA K EMP INS TRL SPCRS (800-99-103) FA LR FMP CUP INSERTER (803-99-098) FA FMP ACET REAMER (803-99-003) FA XALT INST (803-99-040) FA MIS HIP (803-99-028) FA TAPERFILL INSTRUMENTS (803-99-170) FA TAPERFILL INSTRUMENTS – 7MM (803-99-170 FA TAPERFILL BROACHES (803-99-171) FA H TAPERFILL BROACH 7MM POST (803-99-172) FA TAPERFILL BIG LUG FT BROACH (803-99-172) FA K EMP 3D CR TRL PREP OUT LG FA K EMP 3DCR TRL PREP OUT SML FA K EMP CR TRL CORE LT FA K EMP CR TRL CORE RT FA K EMP PS FEM TRL CAP CORE (800-99-117) FA K EMP PS FEM TRL CORE (800-99-117) FA K EMP PS INS TRL CORE (800-99-118) FA K EMP PS TRL PREP OUT L CAP (800-99-108) FA K EMP PS TRL PREP OUT LG (800-99-108) FA K EMP PS TRL PREP OUT S CAP (800-99-107) FA K EMP PS TRL PREP OUT SML (800-99-107) FA K EMP 3D + CR COMP OUT LG FA K EMP 3D + CR COMP OUT SML FA K EMP 3D COMP OUT LG FA K EMP 3D COMP OUT SML FA K EMP COMP PAT TOOL KIT FA K EMP CR COMP OUT LG FA K EMP CR COMP OUT SML FA K EMP TIB PREP 2 FA S ALTIVATE RSP 44 FA S ALTIVATE RSP HUM TRLS SML FA K EMP CEM STEM AUG PREP FA K EMP TIB PREP COMPLETE FA K EMP PS TRL PREP OUT SML 2 FA K EMP PS TRL PREP OUT LG 2 FA K EMP VVC INS TRL CORE FA S ALTIVATE RSP REVISION FA H EMPOWR ACET GENERAL INST FA H EMPOWR ACET MIS HANDLES FA H EMPOWR ACET TRL NEU 10DH FA H EMPWR ACET OFFSET TR LNRS FA H EMPOWR ACET ANCILLARY FA H EMPOWR ACET GEN INST V2 FA H EMPOWR ACET ANCILLARY V2 FA S ALTIVATE RSP SHORT FA K EMP PARTIAL FA K EMP PARTIAL PREP 1 OF 2 FA K EMP PARTIAL TRIAL 2 OF 2 FA S ALT ANATOMIC CS EDGE FA K EMP FEM PREP - ADJ SZR Οι παρακάτω συσκευές καλύπτονται από τις οδηγίες χρήσης 0400-0248 και όχι από αυτές τις οδηγίες χρήσης. FA K EMP PS FEM TRL CAP CORE (800-99-117) FA K EMP PS FEM TRL CORE (800-99-117) FA K EMP PS INS TRL CORE (800-99-118) FA K EMP PS TRL PREP OUT L CAP (800-99-108) FA K EMP PS TRL PREP OUT LG (800-99-108) FA K EMP PS TRL PREP OUT S CAP (800-99-107) FA K EMP PS TRL PREP OUT SML (800-99-107) FA S ALT ANATOMIC HUM STEM (804-99-125) FA S ALT ANATOMIC HUM HEAD (804-99-126) FA S ALT ANATOMIC GLENOID (804-99-127) FA S TURON KEELED GLENOID (804-99-128) FA H EXPRT REV HIP REAMERS (803-99-095) FA H EXPRT REV HIP GENERAL (803-99-096) FA H FMP STR CUP INSERTER (803-99-101) DOUBLE OFFSET BROACH HANDLE, LEFT (803-03-084) DOUBLE OFFSET BROACH HANDLE, RIGHT (803-03-085) FA H HXE NEU-10DH EXTD (803-99-111) 3. Ενδείξεις Ανατρέξτε στις οδηγίες χρήσης του αντίστοιχου εμφυτεύματος για τις ενδείξεις. 4. Χρήση για την οποία προορίζονται Ανατρέξτε στις οδηγίες χρήσης του αντίστοιχου εμφυτεύματος για τη χρήση για την οποία προορίζεται η συσκευή. 5. Αντενδείξεις Ανατρέξτε στις οδηγίες χρήσης του αντίστοιχου εμφυτεύματος για τις αντενδείξεις. 6. Προειδοποιήσεις και προφυλάξεις Ανατρέξτε στις οδηγίες χρήσης του αντίστοιχου εμφυτεύματος για τις συστάσεις και τις προειδοποιήσεις. 7. Προεγχειρητικός σχεδιασμός και μετεγχειρητική φροντίδα Ανατρέξτε στις οδηγίες χρήσης του αντίστοιχου εμφυτεύματος για τον προεγχειρητικό σχεδιασμό και τη μετεγχειρητική φροντίδα. PAGE 23 OF 32

FORM 1000.3004.02 Rev. A

MRI Unsafe MR-unsicher Incompatible avec l’IRM «MRI Unsafe» (esto es, no seguro con la resonancia magnética según la ASTM) Non sicuro in ambienti RM Μη ασφαλές για μαγνητική τομογραφία MRG Güvensiz

ASTM F2503:2013

Rx 21 CFR 801.109

Federal Law (USA) restricts this device to sale by or on the order of a physician. Laut US-Gesetzgebung darf dieses Produkt nur von einem Arzt oder im Auftrag eines Arztes gekauft werden. Selon la loi fédérale (États-Unis), ce dispositif ne peut être vendu que par un médecin ou sur sa prescription. Las leyes federales estadounidenses restringen la venta de este dispositivo a médicos o por prescripción facultativa. Le leggi federali degli Stati Uniti d’America vietano la vendita del presente dispositivo a personale non autorizzato e/o senza prescrizione. Η ομοσπονδιακή νομοθεσία (των Η.Π.Α.) περιορίζει την πώληση της διάταξης αυτής σε ιατρούς ή κατόπιν εντολής ιατρού. ABD yasalarına göre bu cihaz sadece bir doktor tarafından veya emriyle satılabilir. Importer Importeur Importateur Importador Importatore Εισαγωγέας İthalatçı

Article 13.3

Medical Device Medizinprodukt Dispositif médical Dispositivo médico Dispositivo medico Ιατροτεχνολογικό προϊόν Tıbbi Cihaz

MD ISO 15223-1 5.2.8

Country Code of Manufacturer – US Ländercode des Herstellers – US Code pays du fabricant - États-Unis Código de país del fabricante: EE. UU. Codice Paese del fabbricante – US Κωδικός χώρας κατασκευαστή – US Üreticinin Ülke Kodu - ABD

ISO 3166-1

Bone Cement Usage – The following legends are displayed on the product labeling to indicate bone cement usage: Usage

Legend

Implants intended to be used with bone cement

CEMENTED

Implants intended to be used without bone cement

CEMENTLESS

Implants intended to be used optionally

NO LEGEND

Gebrauch von Knochenzement – Die folgenden Legenden erscheinen auf der Produktetikettierung, um auf den Gebrauch von Knochenzement hinzuweisen: Gebrauch Die Implantate sind zum Gebrauch mit Knochenzement bestimmt

Legende ZEMENTIERT

Die Implantate sind zum Gebrauch ohne Knochenzement bestimmt

ZEMENTFREI

Implantate sind zum optionalen Gebrauch bestimmt

KEINE LEGENDE

Utilisation de ciment osseux – Les légendes suivantes sont affichées sur les étiquettes des produits pour indiquer l’utilisation de ciment osseux : Utilisation Implants destinés à être utilisés avec du ciment osseux Implants destinés à être utilisés sans ciment osseux Implants destinés à être utilisés avec ou sans ciment, au choix

PAGE 31 OF 32

Légende AVEC CIMENT SANS CIMENT PAS DE LÉGENDE

FORM 1000.3004.02 Rev. A