PRECICE UNYTE System Instructions for Use

Limb

PRECICE UNYTE Model

C Tibia J Q A-G (except C), V, X Femur H, K, U N, M, P

Humerus

L, M

Nail Diameter

8.5 mm, 9.0 mm, 9.5 mm, 10.0 mm, 10.5 mm 10.7 mm, 11.5 mm, 12.5 mm 8.5 mm 10.7 mm, 12.5 mm 8.5 mm 10.7 mm 8.5 mm, 9.0 mm, 9.5 mm, 10.0 mm, 10.5 mm 10.7 mm, 11.5 mm 12.5 mm 8.5 mm 10.7 mm 12.5 mm 8.5 mm 10.7 mm 165 - 210 mm pre-distracted length 8.5 mm 225 - 300 mm pre-distracted length

Maximum Distance of Treated Limb Surface to IM Canal (ERC1, ERC2P)

Maximum Maximum Distance of Distance of Treated Limb Treated Limb Surface to IM to Surface of Canal (ERC3P) IM Canal (ERC4P)

Maximum Patient Weight

13 mm

13 mm

13 mm

57 Kg

13 mm 13 mm 13 mm 13 mm 13 mm

13 mm 13 mm 13 mm 13 mm 13 mm

16 mm 13 mm 16 mm 13 mm 16 mm

114 kg 57 Kg 114 kg 57 Kg 57 Kg

38 mm

38 mm

45 mm

57 kg

51 mm 51 mm 38 mm 51 mm 51 mm 38 mm 51 mm

51 mm 80 mm 38 mm 51 mm 80 mm 38 mm 51 mm

75 mm 90 mm 45 mm 75 mm 90 mm 45 mm 75 mm

25.4 mm

25.4 mm

25 mm

51 mm

51 mm

45 mm

114 kg 114 kg 57 kg 114 kg 114 kg 57 kg 57 kg Non-weight bearing Non-weight bearing

Potential Adverse Events and Complications: As this is a major surgical procedure, there are known complications associated with orthopedic surgery such as bone fractures, nonunion, delayed union, malunion, premature healing (consolidation), decrease in bone density due to stress shielding, inadequate screw fixation, difficulty with nail or screw removal, early or late infection that may result in the need for additional surgeries, damage to blood vessels or nerves, deep venous thrombosis or pulmonary emboli, acute local inflammatory response, loss of sensory and/or motor function or paralysis, pain, and/or permanent deformity. The following list of failures and adverse events are possible with the Precice UNYTE system. Failure to follow the contraindications, warnings, cautions and precautions listed in this IFU constitute off-label use and may increase the likelihood of these events. • 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.

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•

•

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: • Patients with an open fracture resulting in a 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 involves soft tissues; it is important to allow the soft tissue to heal prior to the lengthening procedure. • The PRECICE UNYTE Nail cannot withstand the stresses of full weight bearing for tibia and femur applications. For humerus applications, patient should not bear any weight on the treated limb. Patient should utilize external support (e.g., crutches or sling) and/or restrict activities until consolidation occurs. • Metallic implants can loosen, fracture, corrode, migrate, or cause pain. • Due to the presence of a magnet, use of the PRECICE UNYTE System is not recommended in patients with pacemakers. Additionally, patients should be evaluated for narcotic dependencies associated with pain management. • The PRECICE UNYTE System may not be appropriate for patients with poly-trauma. • Use of the PRECICE UNYTE 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 UNYTE Nail is supplied sterile and is for single use only. The nail has not been tested to be cleaned, sterilized for multiple uses, or by a method other than gamma irradiation. If the nail is used more than once, the device 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. • The PRECICE UNYTE Nail should be retracted only by a physician. Retraction should be monitored and confirmed using radiography. • To avoid dislocation or subluxation of the shoulder joint with the Humeral Nail, careful preoperative planning should be done to determine the correct lengthening prescription. The typical lengthening prescription for lengthening is 1 mm/day. • Compression and distraction of the Humeral Nail should be performed postoperatively, while the patient is awake to monitor their neurovascular status and radial nerve. • There is a possibility of nerve or soft tissue damage and/or weakness related to either 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. • Patients will require assistance from another person when using the ERC to lengthen the humerus. • Humeral nail distraction may cause traction on nerves. • Patients of the PRECICE UNYTE 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 PRECICE UNYTE System is MR Unsafe. A patient with the implanted PRECICE UNYTE nail must not come near an MRI scanner and must not undergo an MRI scan. LC0095- Rev T-2/2022

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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 External Remote Controller. • During the distraction phase of tibia or femur applications, patient should not participate in contact sports or other high risk activities that cause more than 20% of body weight to be loaded on treated limb. During the distraction phase of humerus applications, patient should not bear weight on the treated limb. These activities may resume upon sufficient bone consolidation, but only as determined by the physician. • Examine all PRECICE UNYTE 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 UNYTE 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 UNYTE Nail, as materials will be attracted to each other. • Do not bend the PRECICE UNYTE Nail or otherwise modify or damage the implant. • Follow the ERC Operators Manual (OM0005, OM0009, OM0016, OM0017)) to assure proper alignment between the ERC and magnet of the PRECICE UNYTE Nail.

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Detail of the PRECICE UNYTE Nail with Locking Screws.

Ø 8.5mm Femoral UNYTE Nail

Ø 8.5mm Humeral UNYTE Nail

Ø11.5mm Tibia UNYTE Nail

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Targeting assembly set up, verify drill bit alignment to implant prior to use

PRECICE Model A – 10° Bend

PRECICE Model B – Straight, Angled Parallel Screwholes

PRECICE Model C – 10° Bend

PRECICE Model D – 10° Bend, Angled Parallel Screwholes

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LOCKING SCREW SIZES Screw Diameter

Screw Type

Head Color

3.5mm

Bolt

GREY

4.0mm

Bolt

BLUE

Threaded

PURPLE

4.5mm

Threaded

SILVER

5.0mm

Bolt

GREEN

Threaded

GOLD

SCREW COMPATIBILITY CHART PRECICE UNYTE Nail Implant Size 8.5mm 10.7mm 11.5mm 12.5mm

PROXIMAL LOCKING SCREW Bolt Threaded

5.0mm

DISTAL LOCKING SCREW Bolt Threaded N/A 3.5mm

5.0mm

5.0mm

Figure 1: Removal Tool Assembly

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4.0mm N/A

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4.0mm 4.5mm 5.0mm

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 UNYTE 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 locking screws and instrument trays prior to the procedure. The PRECICE UNYTE Nail is provided separately in sterile packaging. 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 interfragmentary 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). • The Humeral UNYTE Nail is inserted through a central entry point at the apex of the humeral head, in line with the medullary canal in both AP and lateral views. This entry point can be accessed via an anterolateral approach. Care should be taken to avoid the supraspinatus tendon insertion in the rotator cuff. The rotator cuff should be protected throughout surgery. 8. Reduce the fracture using standard surgical technique. 9. Determine the appropriate nail size and configuration to be used. • The distal tip of the Humeral UNYTE Nail should be at least 1-2 cm proximal to the olecranon fossa. • 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 UNYTE Nail into the medullary canal under image intensification. Advance the PRECICE UNYTE Nail until the device is properly positioned. • It is recommended to counter-sink the Humeral UNYTE Nail 5 mm below the articular surface to avoid subacromial impingement and the incidence of shoulder pain. The distal end of the Humeral UNYTE Nail should be at least 1-2 cm proximal to the olecranon fossa. The proximal end of the Humeral UNYTE Nail should be seated in subchondral bone, just below the articular surface of the proximal humerus. If needed, end caps of up to 15mm in length can be used for the nail. 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. •

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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 UNYTE 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 is provided up to 20 mm pre-distracted (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. 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. 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 UNYTE 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 level of the bone where the magnet in the PRECICE UNYTE 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 compression or lengthening should be checked regularly against follow-up radiographic evidence of the rate of compression or lengthening and the quality of the regenerate. While 1 mm per day is generally recommended for lengthening, clinical and radiographic examination may show that lengthening should progress at a faster or slower pace. Weekly X-ray imaging to confirm distraction length is recommended. Implant Removal Procedures 1. At the time deemed appropriate by the physician, remove the PRECICE UNYTE 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 UNYTE Nail and attach the removal instrumentation. 4. Once all of the locking screws have been removed, the PRECICE UNYTE 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, 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. 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. LC0095- Rev T-2/2022

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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: Step

Solution

1

pH Neutral Hospital Grade Enzymatic Detergent

2

3

4

pH Neutral Hospital Grade Enzymatic Detergent

Distilled or Reverse Osmosis (RO) Water

pH neutral hospitalgrade enzymatic detergent

Time (Minutes)

Temperature

Instruction

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.

2-3

Warm, as delivered from hot water tap

Rinse thoroughly for required time immediately after Step 2. Ensure water flows through all surfaces, cannulas 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.

15 Minutes

40-60oC

14-15 Minutes

As required per detergent instruction

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

5

Distilled or RO water

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2-3

Warm, as delivered from hot water tap

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 borescope 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. P a g e | 11

6

Air

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As required

Ambient

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

2

pH neutral hospitalgrade enzymatic detergent

15 Minutes

Distilled or RO Water

2-3

3

As required

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 nonmetallic) 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.

40-60oC The instrument trays do not require sonication. Warm, as delivered from hot water tap

Rinse thoroughly for required time immediately after Step 2. Ensure water flows through all surfaces, perforations, holes and lumens.

4

N/A

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.

5

Distilled or RO Water

6

Cold

Pre-wash

6

pH Neutral Hospital Grade Enzymatic Detergent

10

55° C

Wash

7

Distilled or RO Water

30

N/A

Rinse

8

Distilled or RO Water

5

93° C

Final Rinse

9

N/A

Vary

Room Temperature

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 borescope 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:

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 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.

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 UNYTE Nail is provided sterilized by Gamma Irradiation Sterilization. • Please refer to the package label for the expiration date of the PRECICE UNYTE Nail. • The PRECICE UNYTE Nail is for Single Use Only. • Do not sterilize the ERC. • Do not attempt to re-sterilize the PRECICE UNYTE Nail. Steam or Ethylene Oxide gas will not reach the internal components of the PRECICE UNYTE Nail. • Do not use if package is damaged or sterile barrier is broken.

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Table 4: 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 or sterile barrier is broken. Do not attempt to re-sterilize the PRECICE UNYTE System Implantable components. 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. Manufactured By Manufactured Date

REF

Model Number

LOT

Lot Number

www.nuvasive.com/eIFU

Refer to Instructions For Use www.nuvasive.com/eIFU Expiration Date Sterilized using 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 7,955,357, 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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