Tritium® SCP Sternal Cable Plate System

System Overview

A HIGHER STANDARD®

TABLE OF CONTENTS

PRODUCT INTRODUCTION .............................................................................................1

FEATURES AND BENEFITS .............................................................................................2

ABBREVIATED SURGICAL TECHNIQUE..........................................................................4

MECHANICAL TESTING ..................................................................................................5

PRODUCT DESCRIPTION ................................................................................................6

IMPLANTS AND INSTRUMENTATION .............................................................................7

INDICATIONS AND WARNINGS .......................................................................................8

1

INCREASED STABILITY

• Offers stability in all planes of motion

• Distributes load, reducing risk of “pull-through”*

• 360° cerclage

• 1.3mm diameter Titanium cable

• Plate and screw thread locking

SYSTEM BENEFITS

• Compression across the osteotomy

• Uniquely designed thin plates for anatomical fit

• Cancellous screws designed for the sternum

• Specially designed instrumentation

O.R. BENEFITS

• Minimal tissue preparation

• Fewer sizing steps

• Reduced learning curve

PRODUCT INTRODUCTION

*Technical data on file at RTI Surgical, Inc.

2

CANCELLOUS SCREW DESIGNdesigned to optimize cancellous bone purchase

QUAD LEAD LOCKING SCREWSminimizes the risk of bone stripping

360° COMPRESSION(1.3mm Ti Cable)

SCREW TARGETING OPTIONS

PRECONTOUREDto better fit patient anatomy

1.7MM LOW PROFILEto reduce tissue irritation

“STAB AND GRAB” RETENTION

FEATURES AND BENEFITS

3

The Tritium SCP System is a novel approach to enhancing the stability and strength of traditional sternal closure techniques. Utilizing a unique load-sharing concept, the device can be implanted to distribute lateral force across the osteotomy.

CABLE TENSIONER

4

2

For the complete Surgical Technique, including comprehensive instructions, labeling and product information, please contact your

RTI Surgical representative.

IMPLANT SELECTIONUse Plate Trials as illustrated for implant selection and Screw Sizer to measure sternal depth (screw length).

1

CABLE INSERTIONUse a needle driver to insert cable parasternally. Cut the leader of the cable to remove the needle and thread the cable through the selected plate. Route cables for all plates through the appropriate levels.

ABBREVIATED SURGICAL TECHNIQUE

3 CABLE TENSIONINGPass the cable through the distal tip of the Tensioner and advance the Tensioner against the plate. Turn the red handle clockwise to tension cable and approximate the sternal halves.

CAUTION: Over-tensioning could result in the cable cutting through the bone. Exercise caution while tensioning the cable.

5

PLATE CRIMPING AND TENSIONER REMOVALPlace the Crimper onto the plate. Align the crimper jaws with the plate crimp location and squeeze the handle until the crimp is fully secured. Remove the Tensioner by depressing the release button located on the red handle.

4

CABLE CUTTINGBy squeezing the Cable Cutter, cut the loose end of the cable once, flush with the plate.

6 SCREW PLACEMENTUsing the Driver’s “Stab and Grab” feature, attach the screw to the Driver and insert the screw through the desired plate screw location. Fully seat the screw head into the plate. The screw head will thread into the plate causing the screw to lock to the plate.

5

A Tritium SCP X Plate was installed on a polyurethane foam block (20 PCF) and loaded to 490N (coughing load1) for 4,200 cycles with separation being measured throughout testing. Separation was measured as the lateral displacement of the entire construct. As a basis for comparison, two single loops of #6 monofilament wire, Biomet Sternalock Blu 8-Hole X Plate and KLS Martin Sternal Talon were tested the same way. The Tritium SCP System had the least amount of separation. The testing shows that Tritium SCP may improve rigidity of a sternal closure and help reduce the risk of separation under repeated coughing. This may promote healing and reduce the risk of infection.*2,3,4,5

*Bench studies are not necessarily indicative of clinical performance. Technical data on file at RTI Surgical, Inc.**Plate disengagement due to catastrophic foam failure.

MECHANICAL TESTING

The Tritium SCP System as shown above offers the most economical option (illustrated by the black cost analysis line) while providing optimal stability, with less than 2mm of separation.

The Tritium SCP System, utilizing cable plate fixation, exhibited superior mechanical properties when compared to wire cerclage. When tested in lateral distraction, the peak load of the Tritium SCP cable plate was approximately 400% greater than parasternal wires.

FATIGUE DISPLACEMENT

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STATIC PEAK LOAD*4500 –

4000 –

3500 –

3000 –

2500 –

2000 –

1500 –

1000 –

500 –

0 –Tritium SCP

Double Cable Plate

Anterior Plating Without Cable

#6 Wire

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6

V PlateThe V Plate has two screw attachment holes located on each side of the main support. The main support spans the sternal osteotomy and the plate surface is precontoured.

X PlateThe X Plate has eight screw attachment holes, two main supports, a crimp location that spans the sternal osteotomy, and has two screw holes in a four-lobe configuration. The X Plate surface is precontoured and has an integrated cable.

Double Cable PlateThe Double Cable Plate has six screw attachment holes, a main support and two integrated crimp locations. The main body spans the sternal osteotomy and has three screw holes in a tri-lobed configuration. The plate surface is not precontoured and has two integrated cables.

Box Plate The Box Plate has four screw attachment holes, two main supports and an integrated crimp location. The main supports and crimp span the sternal osteotomy. The surface is precontoured and the plate has an integrated cable.

Auxiliary Plate The Auxiliary Plate has four screw attachment holes, one main support and an integrated crimp location. The main support spans the sternal osteotomy. The plate surface is precontoured and has an integrated cable with a sharp needle attached.

Ladder PlateThe Ladder Plate has 14 screw attachment holes, is precontoured and spans two intercostal spaces. The plate may be used with the titanium cable of the Sternal Cable System if additional construct stability is desired.

Standard Screw and Rescue ScrewThe plate screw holes are threaded with lead-ins on both sides of the plate allowing the plate to be flippable. The screw threads are self-drilling and cancellous bone specific.

Lateral Fixation

The Tritium SCP System incorporates the advantages of cerclage cables and cancellous screws to create a load sharing design that provides compression across the median sternotomy. Compared to pure lateral or anterior fixation systems, Tritium SCP offers 360° of sternal fixation.

360° FixationTritium SCP

PRODUCT DESCRIPTION

Anterior Fixation

7

IMPLANTS AND INSTRUMENTATION

PLATESPart Number Description Quantity Per Set Ordering Quantity86-100 V Plate (4 Holes) 3 1

86-200 X Plate (8 Holes x 1 Cable) 5 1

86-300 Double Cable Plate (6 Holes x 2 Cables) 4 1

86-300-64 Double Cable Plate 64mm Needle 0 1

86-400 Box Plate (4 Holes x 1 Cable) 3 1

86-500 Auxiliary Plate (4 Holes x 1 Cable) 2 1

86-600 T Plate** (4 Holes x 1 Cable) 2 1

86-700 Ladder Plate (14 Holes) 2 1

SCREWSPart Number Description Diameter Length Quantity Per Set Ordering Quantity86-27-10 Standard Screw 2.7mm 10mm 12 1

86-27-12 Standard Screw 2.7mm 12mm 36 1

86-27-14 Standard Screw 2.7mm 14mm 24 186-27-16 Standard Screw 2.7mm 16mm 24 1

86-30-08 Rescue Screw 3.0mm 08mm 8 186-30-10 Rescue Screw 3.0mm 10mm 8 1

86-30-12 Rescue Screw 3.0mm 12mm 8 1

86-30-14 Rescue Screw 3.0mm 14mm 8 1

86-30-16 Rescue Screw 3.0mm 16mm 8 1

INSTRUMENTATIONPart Number Description Quantity Per Set Ordering Quantity86-TRIAL-100 V Plate Trial 1 1

86-TRIAL-200 X Plate Trial 1 1

86-TRIAL-300 Double Cable Plate Trial 1 1

86-TRIAL-400 Box Plate Trial 1 1

86-TRIAL-500 Auxiliary Plate Trial 1 1

86-TRIAL-700 Ladder Plate Trial 1 1

86-SIZER Screw Sizer 1 1

86-PLTCUTTER-2 Plate Cutter 1 1

86-CBLCUTTER-2 Cable Cutter 1 1

86-DRIVER-2 Screw Driver 2 1

86-DRIVERBIT-2 Driver Bit 2 1

86-TENSIONER-2 Cable Tensioner 2 1

86-CRIMPER Plate Crimper 1 1

86-CASE-2 Sterilization Case 1 1

86-SCRCADDY-2 Screw Caddy 2 1

86-TRLCADDY-2 Trial Plate Caddy 1 1

STERILE SCREWSPart Number Description Sizes (X) Ordering Quantity (Y)86-27-X-SY Standard Sterile Screw (2.7mm) 08 - 16mm 2, 4 & 12

86-30-X-SY Rescue Sterile Screw (3.0mm) 08 - 16mm 2, 4 & 12

**Surgical Technique shown is not applicable to the T Plate. Please reference the T Plate Surgical Technique.

OPTIONAL INSTRUMENTATIONPart Number Description Ordering QuantityPDBP-001-2 Pro-Driver Sterile Battery*† 10

PDSD-5000-1 Pro-Driver† 1

400-410 Cable Cutter 1

*Only shippable in quantities of 10.

† Manufactured by Pro-Dex 2361 McGaw Ave. Irvine, CA 92614 USA 800.562.6204

8

INDICATIONSThe Tritium Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

CONTRAINDICATIONSContraindications may include, but are not limited to:

• Active infection• Foreign body sensitivity, allergy, or intolerance. Where material sensitivity is

suspected, testing is to be completed prior to implantation.• Inadequate tissue coverage of implant site• Patients with limited blood supply; insufficient quantity or quality of bone

including severe osteopenia and/or osteoporosis, rapid bone absorption, metabolic bone disease, cancer, tumor, or tumor like condition of the bone; end stage malignant disease; latent infection; or other unexplained disease

• Severely comminuted fractures• Any patient unwilling or incapable of following postoperative care instructions

POSSIBLE ADVERSE EFFECTS• Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited

revascularization, nonunion, delayed union, or infection can lead to loosening, bending, backout, or fracture of the implant.

• Migration, bending, cracking, fracture, fraying, kinking, disassembly, backout, or loosening of the implant with or without related loss of fracture reduction or dislocation.

• Cable components may cut through soft osteoporotic, osteopenic or cancellous bone if not properly protected and immobilized.

• Metal sensitivity, or allergic reaction to a foreign body.• Irritation or inflammation of soft tissue structures surrounding implant.• Increased fibrous tissue response around the fracture site and/or the implant.• Bone formation surrounding the implant making removal difficult.• Foreign body reaction causing possible tumor-like condition.• Decrease in bone density due to stress shielding.• Infection.• Inadequate healing.• Pain, discomfort, abnormal sensation, or palpability due to the presence of

the device.• Necrosis of bone, cessation of growth of the operated portion of the bone,

possible neurovascular compromise, disruption of blood circulation, and/or vessel damage due to improper cable placement and/or improper assembly of the Sternal Cable Plate System’s components.

• Selection of screws which are longer than the depth of the sternum may cause possible impingement on structures internal to chest wall including vessels, pleura and other structures.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant. It may be necessary to perform additional surgery in order to correct some of the adverse effects or reactions that may or may not be related to the Sternal Cable Plate System.

WARNINGSInternal fixation devices aid the surgeon in the alignment and stabilization of bone in the anterior chest wall for fixation of fractures and reconstructive procedures. While these devices are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the unsupported stress placed upon the device by full load bearing. Internal fixation devices are internal splints, or load sharing devices that align the fracture until normal healing occurs. If there is delayed union, nonunion, or incomplete healing of bone; the implant can be expected to bend, break, or fracture. Therefore, it is important that immobilization of the bony segments be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The size and shape of bones and soft tissue place limitations on the size and strength of implants. Surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s activity level and adherence to load bearing instructions have an effect on the service life of the implant. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants. If nonunion occurs, revise/remove the system.

• Single use device – do not reuse implants under any circumstances. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been even momentarily placed in a different patient. If reused, single use devices may not perform as intended and could cause serious injury.

• Do not intermix implants with different metallic alloy types. Implant materials are subject to corrosion. Implanting metals and alloys subjects them to constant changing environments of salts, acids, and alkalis that can cause corrosion. Putting dissimilar metals and alloys in contact with each other may be detrimental to the patient and/or function of the implant(s).

• Do not bend, contour, cut, or modify implants. Bending or other modifications made to the implant or its component parts increase the risk of fracture or separation.

• Do not implant this device without the appropriate number of screws to achieve bone fixation. Use without the appropriate number of screws may compromise device function and increase the risk of migration or failure.

• Do not use if packaging/implant is damaged or opened prior to use.• Intraoperative fracture of screws can occur if excessive force (torque) is applied

while seating bone screws.• Avoid over tensioning cables as they may break or fray and may cut through

soft bone that is not protected and immobilized.• It is important to watch the sternum and be aware of what the cable and bone

is doing to be sure that it is not cutting through the bone.• Implants may be removed after fracture or other bony non-union has healed.

Implants can loosen, fracture, corrode, migrate, cause pain, discomfort, abnormal sensations; and increase the risk of infection. If an implant remains implanted after complete healing, the implant may cause stress shielding, which may increase the risk of refracture or recurrence of non-union in an active patient or due to trauma. The surgeon should weigh the risks versus benefits when deciding whether to remove the implant. Adequate postoperative management to avoid refracture or recurrence of non-union should follow implant removal.

• For plates with integrated cable: Do not cut or remove cable, these plates are not intended for use without cable.

• This device is not intended to be capable to withstand sudden dynamic loads associated with accidents or falls.

• Do not place the Tritium plates over any other implants such as, but not limited to, plates, wires, screws or cables.

INDICATIONS AND WARNINGS

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PRECAUTIONSInstruments are available for the implant system to aid in the accurate implantation of internal fixation devices. Intraoperative fracture or breaking of instruments may occur. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Pioneer Surgical* recommends that all instruments be regularly inspected for wear and disfigurement.

Surgical instruments must be used only for the device systems for which they are designed. Use of other manufacturer instruments can involve unevaluated risks for the implant and instrument, thereby potentially endangering the patient, user, or third party.

Check packaging of sterile products. For product that is provided sterile, do not use if sterile package has been opened or damaged. If sterile package has been opened or damaged, return the product to Pioneer Surgical. Do not use implants after expiration date, as specified.

Correct handling of implants is extremely important. Modifications including bending and contouring of implants or removal of cable may weaken the implant and contribute to breakage. These implants are not intended to be contoured. Damage including notches or scratches to the implant during the course of surgery may contribute to breakage. If the plate is bent, scratched, or if the cables cannot be properly applied, discard the implant and replace with a new implant.

It is important to be aware of the overall stability of the closure and use as many devices as necessary to achieve adequate fixation based on a surgeon’s assessment for each patient.

Bone Plates:Ensure adequate approximation and alignment of bony anatomy prior to final cable and screw fixation.

Bone Screws:The screwdriver which has been designed for a particular system of screws must always be used to be sure that proper screwdriver/screw head connection is achieved.

Incorrect alignment or fit of the screwdriver to the screw head may increase the risk of damage to the implant or screwdriver.

Screws must be fully seated to verify their connection to the plate; unseated screws may increase the risk of screw backout or compromise their intended function.

Excessive torque can cause the screw to fracture.

Cable:Prior to loosening cable tension, care should be taken to ensure that the plate has been fully crimped according to the operative technique.

To remove excess cable after crimping, make one cut of the cable, flush with the plate.

When using electrocautery, e.g. “Bovie”, to suppress bleeding near the sternum, be mindful not to touch the cables as the multi-filament strands may fray.

Instructions and Postoperative Care:Adequately instruct the patient of the benefits and risks of the system prior to, and after the surgery. Postoperative care is important as is providing clear directions and warnings and obtaining the utmost compliance from the patient postoperatively. The patient’s ability and willingness to follow instruction is one of the most important aspects of successful management of fracture or other non-union. Patients with senility, mental illness, alcoholism, or drug abuse may be at higher risk of device failure since these patients may ignore instructions and activity restrictions. If appropriate, restrict patient’s mobility at the fusion region, and instruct the patient in the use of external supports and braces that are intended to immobilize the site of the fracture. Provide the patient with load bearing restrictions. General information that may be provided to the patient on the use and limitation of these devices include the following:

• The patient is to be made aware and warned that the device does not replace normal healthy bone and that the device can fracture, bend or be damaged as a result of stress, activity, load bearing or inadequate bone healing.

• The patient is to be made aware that the medical device cannot withstand dynamic loads from falls or accidents.

• The patient is to be made aware and warned of general surgical risks, complications, possible adverse effects and to follow the instructions of the treating physician.

• The patient is to be advised of the need for regular postoperative follow-up examination as long as the device remains implanted.

• The patient is to be made aware that if the sternum does not heal, the device will not remain intact indefinitely; the device may fracture.

• The patient is to be advised to contact their physician immediately if they experience unusual pain, severe discomfort, or fever.

• The patient is to be advised that the implant is a temporary device designed to stabilize / secure the bone fracture(s) and augment the process of healing after which time, if conditions are unfavorable, the device may be removed.

• Warn patient against sudden changes in position, strenuous activity, falls, smoking, consuming alcohol or drugs not prescribed by the physician, steroids, non-steroidal anti-inflammatory agents, aspirin, and mechanical vibrations that may loosen the devices.

• The implants are comprised of titanium and titanium alloy.

PIONEER IMPLANTS IN THE MAGNETIC RESONANCE (MR) ENVIRONMENTThe effects of the MR environment have not been determined for this device. This device has not been tested for heating or migration in the MR environment.

See insert for complete labeling limitations related to this device.

*Manufactured by Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. 375 River Park Circle, Marquette, MI 49855 USA

REFERENCES1. Casha A.R, Yang L., et al. A biomechanical study of median sternotomy closure techniques. European Journal of Cardio-thoracic Surgery 15 (1999) 365-369.

2. Li A E, Fishman E K. Evaluation of complications After Sternotomy using single and multidetector CT with three dimensional Volume Rendering AJR 2003; 181 (4): 1065-1070.

3. Schimmer C, Sommer S P, Bensch M, Bohrer T, et al. Sternal closure techniques and postoperative sternal wound complications in elderly patients Eur J Cardiothorac Surg 2008;34:132-138.

4. Snyder C W, Gra ham L A, Byers R E, Holman W L, Primary sternal plating to prevent sternal wound complications after cardiac surgery: early experience and patterns of failure Interact Cardio Vasc Thorac Surg 2009;9:763-766.

5. Zacharias A, Habib R H. Factors predisposing to median sternotomy complications CHEST 1996; 110: 1173-1178.

INDICATIONS AND WARNINGS

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375 River Park CircleMarquette, MI 49855 USA

t: 800.557.9909www.rtisurgical.com

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