FREEDOM Nail Instructions for Use

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Soft tissue contractures, loss of joint motion, subluxation and/or dislocation could result in pain or surgical intervention to resolve. Preventative measures should be considered such as but not limited to proactive examinations, change of prescription, bracing, physical therapy, and tissues releases Local tissue discoloration (i.e., metallosis), osteolysis, local acute inflammatory response, pain or other harms associated with exposure to wear debris, metal nanoparticles, and elevated titanium serum ion levels (including neurological issues and the risks associated with reproductive and developmental toxicity). Exposure to biohazards or non-biocompatible materials potentially leading to immunological response, pain, skin irritation/rash/sensitization, developmental toxicity related harms and/or infection and which may require medical intervention such as revision surgery. Loss of distraction or uncontrolled lengthening which may lead to pain, loss of correction, extension of treatment, progression of deformity, increased limb length discrepancy, overlengthening, poor regenerate and/or necessitate revision surgery. Implant bending, fracture, loosening, disassociation and/or loss of fixation resulting in medical intervention such as revision surgery. Failure to lengthen which may lead to delays in surgery (leading to additional blood loss and extended exposure to anesthesia), extension of treatment, suboptimal correction, and/or necessitate revision or reoperation. Treatment complications from anatomical compatibility issues due to implant configuration selection, implant removals and/or implant sterility which may lead to delays in surgery (leading to additional blood loss and extended exposure to anesthesia), inability to complete the procedure and/or cancellation of the procedure, or may result in pain, abnormal sensations and/or suboptimal correction.

Warnings: • The FREEDOM is a non-weight bearing device and cannot withstand the stresses of full weight bearing on a prosthetic. Patients should utilize external support or wheelchair until consolidation occurs. • Metallic implants can loosen, fracture, corrode, migrate, or cause pain. • Due to the presence of a magnet, use of the FREEDOM System is not recommended in patients with pacemakers. • The FREEDOM System may not be appropriate for patients with poly-trauma. • Use of the FREEDOM System in patients with an active infection of the limb is not recommended. • Smoking, chronic steroid use and the use of other anti-inflammatory drugs have been determined to affect bone healing and could potentially have an adverse effect of the bone regenerate during the lengthening process. Additionally, patients should be evaluated for narcotic dependencies associated with pain management. • The FREEDOM nail is supplied sterile and is for single use only. The nail has not been tested to be cleaned or sterilized for multiple uses. If the nail is used more than once, the device may not be sterile and could cause a serious infection. • The locking screws may be provided sterile or non-sterile, take careful note to read packaging if screw is provided sterile or non-sterile. • Before removing the implants from the package, make sure that the protective packaging is unopened and undamaged. If the packaging is damaged, the implants have to be considered as NON-STERILE and may not be used. • Note the STERILE expiry date. Implants with elapsed STERILE expiry dates have to be considered as non-sterile. • Patients of the FREEDOM System should not be implanted with more than two devices at a time and the patient’s weight should be a minimum of 50 lbs. Failure to follow this criteria may result in the potential adverse events and complications described above. • MRI Information: The FREEDOM System is MR Unsafe. A patient with the implanted FREEDOM nail must not come near an MRI scanner and must not undergo an MRI scan.

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Precautions: • Do not use this device without proper training in both device implantation and adjustment. Refer to External Remote Controller (ERC 1, ERC 2P, ERC 3P, or ERC 4P) Operator’s Manual (OM0005, OM0009, OM0016, OM0017) for operation of the ERC. • Examine all FREEDOM System components carefully prior to use to assure proper working condition. If you suspect a component to be faulty or damaged, do not use. Cautions: • The FREEDOM System is for prescription use only by the order of a physician. • Residual limb lengthening has a risk of skin thinning and bony penetration through unstable skin. Prior to implantation, careful physician assessment of the soft tissue envelope needs to be completed. The patient’s skin should be in optimal condition prior to lengthening. Plastic surgery techniques of muscle advancement or free tissue flap coverage can be considered prior to residual limb lengthening. • Device should be removed after implantation time of no more than one year. Prior to explant, ensure full consolidation of 3 or more cortices is radiographically visible for both AP and lateral views. • The diameter of the FREEDOM Nail is 14 mm and requires reaming of the canal up to 16 mm. This may result in an increased risk of fracture for patients with a narrower canal. Ensure the patient has a large enough diameter of the intramedullary canal to accommodate the FREEDOM Nail prior to implantation. • To help prevent osteopenia and bone fracture, patients should maintain a healthy diet with adequate Vitamin D and Calcium. Consider measuring these levels and using supplements as needed. • Utilize extreme caution when handling instruments made from magnetic materials such as stainless steel in proximity of the magnet of the FREEDOM nail, as materials will be attracted to each other. • Do not bend the FREEDOM nail or otherwise modify or damage the implant. • After the surgical procedure is complete, if retraction is needed, retract device no more than the amount lengthened the preceding day. Failure to follow this caution may result in pulling biologic material that may have adhered to the rod into internal space of the Nail. • Follow the ERC Operators Manual to assure proper alignment between the ERC and magnet of the FREEDOM nail.

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Figure 1: Detail of the FREEDOM Nail with Locking Screws

Figure 2: Drill guide set up. Verify drill bit alignment to implant prior to use.

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Figure 3: Removal Tool Assembly

Procedures Careful pre-operative diagnosis and planning, meticulous surgical technique, and extended postoperative care by experienced surgeons are essential to procedure success. Prior to use, the surgeon should be specifically trained in the use of the FREEDOM System along with the associated instruments to facilitate correct selection, placement and security of the implant. Implantation Procedure: 1. Thoroughly clean the instruments according to the parameters in Table 1 or 2 prior to sterilization. 2. Inspect the instruments after cleaning to check for damage prior to sterilization. Functional check should include ensuring mating instruments can be properly assembled and instruments with moving parts are operated to ensure correct operation. 3. Sterilize screws, instrument tray and accessory tray prior to the procedure. The FREEDOM nail is provided separately in sterile packaging. 4. Use standard surgical techniques to provide for adequate venting of the intramedullary canal during surgery. 5. After accessing the insertion site, use an awl or sterile entry drill to open the intramedullary canal. Use care to keep the straight part of the shaft of the opening instrument parallel to the long axis of the bone shaft. 6. If using flexible reamers, insert a guide wire into the medullary canal and advance until the tip of the wire reaches the intended location. Imaging in two planes is required while advancing the guide wire. 7. Ream the intramedullary canal 2 mm greater than the diameter of the FREEDOM nail. The cortices must be at least 3mm thick at any location once reamed. 8. Create an osteotomy at the appropriate location in the bone. It is recommended that the osteotomy is created below the lesser trochanter in the metaphyseal bone. 9. After attaching the Drill Guide Assembly to the FREEDOM nail, insert the device into the intramedullary canal under image intensification. Advance the device until it is properly positioned. 10. Use the Drill Guide to control alignment and then secure the proximal portion of FREEDOM nail using one proximal locking screw of appropriate length. The head of the screw should be flush with the bone surface. 11. Using a free hand technique and fluoroscopic imaging, secure the distal portion of the FREEDOM nail using one locking screw of appropriate length. The head of the screw should be flush with the bone surface. 12. Remove the FREEDOM Drill Guide Assembly. Carefully irrigate the surgical site to remove any remaining bone fragments. Optional: Place the end cap on the FREEDOM Nail.

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13. Disassemble the Drill Guide in reverse order from Step 9 prior to cleaning. Clean instruments after use, without allowing instruments to completely dry prior. 14. Locate the center of the implanted magnet and mark the patient’s skin with indelible marker at this location. 15. Close and dress the site using standard techniques. 16. Instruct the patient to maintain the indelible marker mark at the same location on their limb.

Post-Operative Procedures: 1. Read the External Remote Controller (ERC) Operator’s Manual prior to performing an adjustment of the FREEDOM nail. 2. Identify the mark on the limb where the magnet in the FREEDOM nail is located. Carefully place the ERC firmly but comfortably over this area in the correct orientation. 3. Distract the implant to the prescribed amount, as viewed on ERC display screen. 4. Carefully place the ERC back in its storage container and close. 5. The progress and efficacy of lengthening should be checked regularly against follow-up radiographic evidence of the rate of lengthening and the quality of the regenerate. While 1 mm per day is generally recommended, clinical and radiographic examination may show that lengthening should progress at a faster or slower pace. Weekly X-ray imaging to assess actual distraction length is recommended. Implant Removal Procedures: 1. At the time deemed appropriate by the physician, remove the FREEDOM nail using standard intramedullary nail surgical technique. 2. Follow all cleaning and sterilization procedures to prepare the instruments prior to removal. 3. Remove the End Cap if necessary, access the proximal end of the FREEDOM nail, remove the proximal locking screws and attach the Tapered Extractor or Locking Rod. 4. Once the locking screws have been removed, the FREEDOM nail can be removed by using the removal tool assembly which consists of the removal rod, tapered extractor or locking rod and the slap hammer. 5. Close and dress the wound using standard surgical techniques. 6. Return the explanted product to NuVasive Specialized Orthopedics, Inc. following instructions provided. Please call 1-855-435-5477 to obtain instructions or if you have any questions. Cleaning and Sterilization Instructions The Instrument Tray, Locking Screw Tray (if screws are provided non-sterile), and instruments are provided non-sterile and must be cleaned and sterilized prior to use. The Precice Screws are provided non-sterile or sterile, check labeling before proceeding. Sterilization instructions only pertain to nonsterile locking screws. These instructions are provided in accordance with AAMI TIR12 and ISO 17664 and are intended to supplement a hospital’s existing cleaning and disinfecting protocols. Cleaning Instructions: Thoroughly clean and inspect the trays and instruments for damage prior to loading, wrapping, and sterilization. Disassemble the Instrument Tray and Locking Screw Tray by removing the lid from the tray base. Remove the instruments from the instrument holders. Note: Do not allow instruments to completely dry prior to cleaning. The recommended cleaning instructions for the Instrument Tray, Locking Screw Tray, and instruments are as follows:

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Table 1: Manual Cleaning Recommendations: Step

Solution

Time (Minutes)

Temperature

Instruction

1

pH Neutral Hospital Grade Enzymatic Detergent

14-15 Minutes

Room Temperature

Disassemble instrument trays, remove the instruments from the instrument holders, and disassemble instruments before immersing, soaking, and performing the cleaning. Immerse and soak for required time.

Room Temperature

Clean thoroughly. Scrub all external surfaces with a soft bristle brush until all visible soil has been removed. It is important to make sure all areas of the tray and instruments are cleaned. Ensure that the holes and lumens are effectively cleaned by using a small diameter brush (tight-fitting, soft and non-metallic) or pipe cleaner to clean holes and lumens. Inspect for visible soil on exposed surfaces. Pay attention to threads, hinges and occluded areas of the instrument trays and instruments, and any hard-to-reach areas. Inspect for visible soil on exposed surfaces and make sure there is no visible soil on the exposed surfaces.

2

pH Neutral Hospital Grade Enzymatic Detergent

As required per detergent instruction

3

Distilled or Reverse Osmosis (RO) Water

2-3

Warm, as delivered from hot water tap

4

pH neutral hospital- grade enzymatic detergent

15 Minutes

40-60oC

5

Distilled or RO water

2-3

Warm, as delivered from hot water tap

6

Air

As required

Ambient

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Rinse thoroughly for required time immediately after Step 2. Ensure water flows through all surfaces, perforations, holes and lumens. Inspect for visible soil on exposed surfaces and make sure there is no visible soil. Particular attention should be given to surfaces, perforations, lumens, hinges, and holes. Immerse and sonicate the instruments for the required time. The instrument trays do not require sonication. Rinse thoroughly for required time immediately after Step 4. Ensure water flows through all surfaces, perforations, holes, and lumens. Visually inspect the trays and instruments for visible soil or detergent. Particular attention should be given to surfaces, perforations, lumens, hinges, and holes. Tools such as lighting, magnifying glass, or boroscope may be used to inspect lumens or holes for visible soil. Perform an additional rinse if soil or detergent is still present and visually inspect. Repeat cleaning process if soil or detergent is still present. Allow to air dry in clean area. Blow perforations, holes, and lumens or any internal areas with clean air using filtered air source or syringe.

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Table 2: Automatic Cleaning Recommendations: Step

Solution

Time (Minutes)

Temperature

Instruction Disassemble instrument trays, remove the instruments from the instrument holders, and disassemble instruments before immersing, soaking, and performing the cleaning. For instruments or trays with complex design features such as perforations, lumens, holes, threads or a hard to reach area, it is necessary to soak the instruments and manually scrub all external and internal surfaces with a soft bristle brush, a small diameter brush (tight-fitting, soft and non-metallic) or pipe cleaner until all visible soil has been removed prior to automatic reprocessing to improve the removal of adherent soil. Immerse and sonicate the instruments for the required time by the manufacturer.

1

pH Neutral Hospital Grade Enzymatic Detergent

As required

Room Temperature

2

pH neutral hospital- grade enzymatic detergent

15 Minutes

40-60oC

3

Distilled or reverse osmosis (RO) water

2-3

Warm, as delivered from hot water tap

4

N/A

N/A

N/A

6

Cold

Pre-wash

10

55° C

Wash

30

N/A

Rinse

5

93° C

Final Rinse

Vary

Room Temperature

5

6

7 8 9

10

Distilled or RO Water pH Neutral Hospital Grade Enzymatic Detergent Distilled or RO Water Distilled or RO Water N/A

N/A

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N/A

N/A

The instrument trays do not require sonication. Rinse thoroughly for required time immediately after Step 2. Ensure water flows through all surfaces, perforations, holes and lumens. Load the lid, tray base, and insert tray such that all surfaces of the trays are exposed to the cleaning solutions. Load the instruments so that cannulations, lumens or holes can drain. Do not place heavier instruments on top of delicate instruments.

Dry Visually inspect the trays and instruments for dryness and visible soil or detergent. Particular attention should be given to surfaces, cannulas, hinges, lumens or holes. Tools such as lighting, magnifying glass, or boroscope may be used to inspect long cannulas, lumens or holes for visible soil. If soil or detergent is visible, repeat cleaning.

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Sterilization Instructions: After cleaning the instrument tray and instruments, prior to sterilization, inspect all parts of the tray and instruments for damage. A functional inspection should also be performed where possible. Mating devices should be checked for proper assembly and devices with moving parts should be operated to check for correct operation. Load the base tray with the specified instruments or locking screws and secure the tray lid. Ensure that the tray base and lid can be secured using the latches and handles. If you suspect the tray or an instrument to be damaged, do not use the tray and/or instrument and contact NuVasive Specialized Orthopedics, Inc. for a replacement and/or repair. The Instrument and Locking Screw Trays have been qualified to be sterilized in a double wrapped configuration with a legally marketed, FDA cleared sterilization wrap (Such as CSR Wrap), using the following steam sterilization cycle:

Table 3: Double Wrapped Sterilization Recommendations: Sterilization Cycle

Sterilization Temperature

Sterilization Time (Minutes)

Drying Time (Minutes)

Pre-vacuum steam sterilization cycle

132° C

4

Minimum 40

Maximum Tray Weight 25 lbs

The Instrument Tray has also been qualified to be sterilized using Aesculap Rigid Containers, US only, using the following configurations and steam sterilization cycle:

Table 4: Aesculap Container Configurations Base Options Description Solid Bottom 4.75"

Aesculap NUVA PN JK442B (screen printed) JK442 (laser marked) Lid Options

Nuva PN DM-JK442B DM-JK442B

Description Aluminum Lid (Purple) Aluminum Lid (Silver)

Aesculap NUVA PN XG349 JK489B

Nuva PN 8803001 8803002

Table 5: Aesculap Rigid Container Sterilization Recommendations:

Pre-vacuum steam sterilization cycle

Sterilization Temperature

Sterilization Time (Minutes)

Drying Time (Minutes)

Maximum Tray Weight

132° C

4

Minimum 40

25 lbs

Precaution: When sterilizing instruments and locking screws, do not load the tray more than the weight specified in Table 3 or 5 above.

Limits of Reuse: The instrument trays are reusable and actual limits of reuse for the instrument trays are based upon the proper handling, use, care and cleaning of the trays. The end of tray life is to be determined by wear and damage due to use and through the inspection of the trays after the cleaning and sterilization cycles. Discontinue use of the device if visible signs of wear are present. This includes cracking, peeling, flaking, rusting, and/or discoloration. Always inspect the instrument trays and its components between uses. For trays and instruments that are no longer functional, or exhibit excessive wear and tear, please return them to NuVasive Specialized Orthopedics for replacement.

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Storage: Recommended storage of the Instrument Tray is at controlled ambient temperature 20° - 24° C (68° - 75° F). Ensure that the sterilized tray is stored in areas that provide protection from dust, moisture, insects, and extremes of temperature and humidity.

Other Information: • •

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Upon removal from the package, compare the descriptions on the label with the package contents (product number and size) Packages for each of the components should be intact upon receipt. All implants should be carefully examined for completeness, and for lack of damage, prior to use. Damaged packages or products should not be used, and should be returned to NuVasive Specialized Orthopedics. The FREEDOM nail is provided sterilized by Gamma Irradiation Sterilization. Please refer to the package label for the expiration date of the FREEDOM nail. The FREEDOM nail is for Single Use Only Do not sterilize the ERC. Do not attempt to re-sterilize the FREEDOM nail. Steam or Ethylene Oxide gas will not reach the internal components of the FREEDOM nail. Do not use if package is damaged or sterile barrier is broken

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Table 6: Symbols Definition: Symbol

Definition Unsafe in Magnetic Resonance Imaging (MRI) Environments For Single Use Only, Do not re-use Do not use if package is damaged Do not Resterilize Non-Sterile, Sterilize by Steam before Use

Rx Only/

Federal (US) law restricts the sale of this device for use by or on the order of a physician. Manufacturer Date of Manufacture

REF

Model Number

LOT

Lot Number

www.nuvasive.com/eIFU

See Instructions For Use www.nuvasive.com/eIFU

Expiration Date Sterilized by Gamma Irradiation Authorized European Representative Authorized Swiss Representative This product has met European Union health, safety, and environmental requirements, which ensure consumer and workplace safety.

Authorized Representative:

Manufacturer: Nuvasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA, 92656 USA Tel. 1-855-435-5477 Email: [email protected]

NuVasive Netherlands B.V. Jachthavenweg 109A 1081 KM Amsterdam The Netherlands +31 20 72 33 000

Australian Sponsor: Life Healthcare Pty Ltd. Level 8, 15 Talavera Road North Ryde NSW 2113 Australia

UK Responsible Person: NuVasive UK Limited Suite B, Ground Floor, Caspian House The Waterfront, Elstree Herts United Kingdom

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NuVasive Switzerland GmbH c/o Domenghini & Partners AG Falkengasse 3 6004 Luzern, Switzerland

This product, and the use thereof, may be covered by one or more of the following U.S. and/or international patents: US 7,981,025, US 8,057,472, US 8,197,490, US 8,343,192, US 8,382,756, US 8,419,734, US 8,449,543, US 8,734,488, US 8,808,163, CN 101917918, EP 2,114,258. Other US and international patents pending. This product is licensed to the customer for single use only. Any resterilization or subsequent re-use is an unlicensed use and therefore constitutes patent infringement. only

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