PRECICE STRYDE System Instructions for Use

Limb

Tibia

Femur

PRECICE STRYDE™ Model

C, SJ A,B,D,E V, X

Nail Diameter (mm)

10.0 11.5 13.0 10.0 11.5 13.0

Maximum Distance of Treated Limb Surface to IM Canal (ERC1, ERC2P, ERC3P) 13mm 13mm 13mm 50mm 65mm 80mm

Maximum Distance of Treated Limb Surface to IM Canal (ERC4P)

Max. Patient Weight

13mm 16mm 16mm 70mm 85mm 100mm

150lbs/69kg 200lbs/91kg 250lbs/114kg 150lbs/69kg 200lbs/91kg 250lbs/114kg

Warnings: •

The PRECICE STRYDE™ nail cannot withstand the stresses of full weight bearing. Patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs. • Patients with an open fracture resulting in limb length discrepancy may also have soft tissue damage as a result of severe trauma. It is important that soft tissue damage is addressed prior to lengthening to minimize the risk of infection. • Limb lengthening also involved soft tissues; it is important to allow the soft tissue to heal prior to the lengthening procedure. • Do not use if the sterile packaging has been damaged or appears to have been previously opened. • Metallic implants can loosen, fracture, corrode, migrate, or cause pain. • Due to the presence of a magnet, use of the PRECICE STRYDE™ System is not recommended in patients with pacemakers. • The PRECICE STRYDE™ System may not be appropriate for patients with poly-trauma. • Use of the PRECICE STRYDE™ System in patients with an active infection of the treated bone 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. • The PRECICE STRYDE™ 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 Precice 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 with implanted PRECICE STRYDE™ nail should not enter an MRI unit.

•

The PRECICE STRYDE™ System is unsafe in Magnetic Resonance Imaging environments.

•

The PRECICE STRYDE™ Nail should be retracted only by a physician. Retraction should be monitored and confirmed using radiography. There is a possibility of nerve or soft tissue damage and/or weakness related to either

•

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surgical trauma or the presence of the implant. Advise the patient to notify the surgeon of any experienced pain, numbness, or weakness while undergoing treatment. Precautions: •

•

•

Do not use this device without proper training in both device implantation and adjustment. Refer to External Remote Controller (ERC, ERC 2P, ERC 3P, or ERC 4P) Operator’s Manual (OM0005, OM0009, OM0016, or OM0017) for operation of the External Remote Controller. During the distraction phase, patient should not participate in contact sports or other highrisk activities that will cause a load to the treated limb in excess of the maximum patient weight, as identified in the contraindications. Examine all PRECICE STRYDE™ 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 PRECICE STRYDE™ System is for prescription use only by the order of a physician. Device should be removed after implantation time of no more than one year. Utilize extreme caution when handling instruments made from magnetic materials such as stainless steel in proximity of the magnet of the PRECICE STRYDE™ nail, as materials will be attracted to each other. After the surgical procedure is complete, if retraction is needed during the lengthening or consolidation phase, retract the 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 the internal space of the Nail. Do not bend the PRECICE STRYDE™ nail or otherwise modify or damage the implant. Follow the ERC Operators Manual (OM0005, OM0009, OM0016, or OM0017) to assure proper alignment between the ERC and magnet of the PRECICE STRYDE™ nail.

Stainless Steel Locking Screw Compatibility

Screw Diameter

Screw Type

Screw Lengths (mm)

Distraction Rod

4.0 mm

Partial Thread/Peg

20-75

10.0

Housing Tube

5.0 mm

Partial Thread/Peg

20-80

11.5

Distraction Rod

4.5 mm

Partial Thread/Peg

20-80

11.5

Housing Tube

5.0 mm

Partial Thread/Peg

20-80

13.0

Distraction Rod

Partial Thread/Peg

20-80

13.0

Housing Tube

Partial Thread/Peg

20-80

Nail Diameter (mm)

Screw Position

10.0

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5.0 mm

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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 PRECICE STRYDE™ System along with the associated instruments to facilitate correct selection, placement and security of the implant. Implantation Procedure For fracture reduction applications: 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 locking screws (if provided non-sterile) and instrument trays prior to the procedure. The PRECICE STRYDE™ Nail is provided separately in sterile packaging. The Precice Screws are provided non-sterile or sterile, check labeling before proceeding. 4. Position patient per standard technique. 5. Check for length and rotation by comparison to the unaffected limb. 6. Intra-articular fracture components should be addressed with inter-fragmentary screw fixation prior to nail insertion. Care should be taken to place the screws in the anterior and posterior aspect of the distal long bone and safely out of the nail’s intended path. 7. Identify and access the appropriate entry point for the delivery technique chosen (i.e., antegrade or retrograde). 8. Reduce the fracture using standard surgical technique. 9. Determine the appropriate nail size and configuration to be used. • It is recommended to select an implant length that will provide a minimum of 2 cm of housing tube following total lengthening distal to the fracture/osteotomy site. 10. 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. 11. Ream the intramedullary canal sequentially in half millimeter increments to a size 1.0 to 1.5 mm larger than the selected nail diameter. 12. After attaching the Drill Guide to the implant, insert the PRECICE STRYDE™ Nail into the medullary canal under image intensification. Advance the PRECICE STRYDE™ Nail until the device is properly positioned. 13. Using the Drill Guide mounted to control alignment, secure the proximal portion of the lengthener using proximal locking screws of appropriate length. The head of the screw should be flush with the bone surface. Do not drill additional holes until securing the previous locking screw. 14. Using a free hand technique and fluoroscopic imaging, secure the distal portion of the lengthener using distal locking screws of appropriate length. The head of the screw should be flush with the bone surface. 15. Remove the Drill Guide and associated accessories and carefully irrigate to remove any remaining bone fragments. Attach the End Cap to the proximal end of the PRECICE STRYDE™ Nail. Carefully irrigate the surgical site to remove any remaining bone fragments. 16. Disassemble the Drill Guide in reverse order from Step 12 prior to cleaning. Clean instruments after use, without allowing instruments to completely dry prior. 17. To provide compression to the reduced fracture, cover the ERC with sterile drape. Locate the ERC magnets over the actuator position and activate the ERC to shorten the implant. The implant may be shortened by up to 10 mm (depending on selected implant) to provide this amount of compression to the reduced fracture. Use radiography to ensure that the implant has retracted the desired amount. LC0259-L-6/2022

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18. Locate the center of the implanted magnet and mark with indelible marker. 19. Close and dress the site using standard techniques. 20. Instruct the patient to maintain the indelible marker mark at the same location. For limb lengthening applications: 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 locking screws (if provided non-sterile) and instrument trays prior to the procedure. The PRECICE STRYDE™ nail is provided separately in sterile packaging. The Precice Screws are provided non-sterile or sterile, check labeling before proceding. 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 medullary canal. Use care to keep the straight part of the shaft of the 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 PRECICE STRYDE™ 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. • Note: Do not perform the osteotomy in the proximal or distal metaphyseal areas where the larger intramedullary canal diameter may lead to instability of the distracted fragment, and higher bending moments may result in excessive loading of the implant. 9. For tibial cases, also create an osteotomy in the fibula. To ensure that the fibula lengthens with the tibia, consider using screws to secure the osteotomized fibula to the tibia both distally and proximally. 10. After attaching the Drill Guide to the PRECICE STRYDE™ nail and tightening down the Locking Bolt and Impactor with a tommy bar or 6mm driver, insert the device into the medullary canal under image intensification. Advance the device until it is properly positioned. 11. Use the Drill Guide to control alignment and then secure the proximal portion of PRECICE STRYDE™ nail using two proximal locking screws of appropriate length. The head of the screw should be flush with the bone surface. Do not drill a second hole until securing the first locking screw. Using a free hand technique and fluoroscopic imaging, secure the distal portion of the PRECICE STRYDE™ nail using two locking screws of appropriate length. The head of the screw should be flush with the bone surface. 12. Remove the Drill Guide and associated accessories. Attach the End Cap to the proximal end of the PRECICE STRYDE™ nail. Carefully irrigate the surgical site to remove any remaining bone fragments. 13. Disassemble the Drill Guide in reverse order from Step 10 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.

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Post-Operative Procedures 1. Read the External Remote Controller (ERC) Operator’s Manual (OM0005, OM0009, OM0016, or OM0017) prior to performing an adjustment of the PRECICE STRYDE™ nail. 2. Determine the amount of adjustment required to compensate for any length discrepancy between the treated limb and the unaffected limb or any additional compression or distraction desired. 3. Identify the mark on the limb where the magnet in the PRECICE STRYDE™ nail is located. Carefully place the ERC firmly but comfortably over this area in the correct orientation. 4. Retract or distract the implant to the desired amount, as viewed on ERC display screen. Retraction should only be performed by a physician with the aid of radiography. 5. Carefully place the ERC back in its storage container and close. 6. 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 PRECICE STRYDE™ nail using standard surgical technique. 2. Follow all cleaning and sterilization procedures to prepare the instruments prior to removal. 3. Access the distal end of the PRECICE STRYDE™ nail and attach the removal instrumentation. 4. Once all of the locking screws have been removed, the PRECICE STRYDE™ nail can be removed by using the removal tool assembly which consists of the locking rod, removal rod and the slap hammer. Disassemble removal tool assembly prior to reprocessing after the removal surgery. 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 non-sterile locking screws. 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.

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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: Table 1: Manual Cleaning Recommendations:

Time (Minutes)

Step

Solution

Temperature

1

pH Neutral Hospital Grade Enzymatic Detergent

14-15 Minutes

Room Temperature

2

pH Neutral Hospital Grade Enzymatic Detergent

As required per detergent instruction

Room Temperature

3

Distilled or Reverse Osmosis (RO) Water

2-3

Warm, as delivered from hot water tap

4

pH neutral hospitalgrade enzymatic detergent

15 Minutes

40-60°C

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. 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 (tightfitting, 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. 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.

5

Distilled or RO water

2-3

Warm, as delivered from hot water tap

6

Air

As required

Ambient

LC0259-L-6/2022

Instruction

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)

1

pH Neutral Hospital Grade Enzymatic Detergent

As required

2

pH neutral hospitalgrade enzymatic detergent

15 Minutes

3

4

Distilled or reverse osmosis (RO) water

N/A

Temperature

Instruction

Room Temperature

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.

40-60°C

Immerse and sonicate the instruments for the required time by the manufacturer. The instrument trays do not require sonication.

2-3

Warm, as Rinse thoroughly for required time immediately delivered from after Step 2. Ensure water flows through all hot water tap surfaces, perforations, holes and lumens.

N/A

N/A

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.

Distilled or RO Water pH Neutral Hospital Grade Enzymatic Detergent Distilled or RO Water

6

Cold

Pre-wash

10

55°C

Wash

30

N/A

Rinse

8

Distilled or RO Water

5

93°C

Final Rinse

9

N/A

Vary

Room Temperature

5

6

7

10

N/A

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N/A

N/A

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 Temperature

Sterilization Time (Minutes)

Drying Time (Minutes)

Maximum Tray Weight

132° C

4

Minimum 40

25 lbs

Pre-vacuum steam sterilization cycle

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)

Nuva PN DM-JK442B DM-JK442B

Lid Options 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. LC0259-L-6/2022

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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.

MRI Information: • •

The PRECICE STRYDE™ System is MR Unsafe. A patient with the implanted PRECICE STRYDE™ nail must not come near an MRI scanner and must not undergo an MRI scan.

Other Information: •

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 PRECICE STRYDE™ nail is provided sterilized by Gamma Irradiation Sterilization. • Please refer to the package label for the expiration date of the PRECICE STRYDE™ nail. • The PRECICE STRYDE™ nail is for single-use only. • Do not sterilize the ERC. • Do not attempt to re-sterilize the PRECICE STRYDE™ Nail. Steam or Ethylene Oxide gas will not reach the internal components. • 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 Federal (US) law restricts the sale of this device for use by or on the order of a physician.

Rx Only/

Manufacturer Date of Manufacture

REF

Model Number

LOT

Lot Number

www.nuvasive.com/eifu

See Instructions For Use www.nuvasive.com/eifu Expiration Date Authorized Swiss Representative Sterilized by Gamma Irradiation This product has met European Union health, safety, and environmental requirements, which ensure consumer and workplace safety.

EC | REP

Authorized European Representative

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

EC | REP NuVasive Netherlands B.V. Jachthavenweg 109A 1081 KM Amsterdam The Netherlands Phone: +31 20 72 33 000

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

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

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 7,955,357, US 7,981,025, US 8,057,472, US 8,197,490, US 8,382,756, US 8,419,734, US 8,449,543, US 8,715,159, US 8,734,488, US 8,808,163, CN 101917918, EP 2,114,258. Other U.S. 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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