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MatrixRIB This publication is not intended for distribution in the USA.SURGICAL TECHNIQUE

WarningThis description alone does not provide sufficient background for direct use ofthe instrument set. Instruction by a surgeon experienced in handling theseinstruments is highly recommended.Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-partinstruments, as well as processing guidelines for implants, please contact yourlocal sales representative or refer are-maintenanceFor general information about reprocessing, care and maintenance of Synthesreusable devices, instrument trays and cases, as well as processing of Synthesnon-sterile implants, please consult the Important Information leaflet(SE 023827) or refer are-maintenance

TABLE OF CONTENTSINTRODUCTIONBackground 2MRI Information 6Intended use, Indications, Contraindications andWarnings 7MatrixRIB 11SURGICAL TECHNIQUEMIPO INSTRUCTIONSAO Principles 14Plating Rib 15Splint Insertion 25Plating Sternum 33Minimally Invasive Plate Osteosynthesis (MIPO) 44MatrixRIB Trocar Instruments Instructions 45Threaded Reduction Tool Instructions 4890 Screwdriver for MatrixRIB System Instructions 51CHEST WALL DEFECT REPAIR Chest Wall Reconstruction, including Spanning Gaps 53Chest Wall Deformity Repair PRODUCT INFORMATION64Implants 68Instruments 70REFERENCES 77MatrixRIB Surgical TechniqueDePuy Synthes1

BACKGROUNDRIB FRACTURESRib fractures are common in blunt chest wall trauma.The fractured ribs usually heal on their own without specific treatment, but a subset of patients have fractures that produce overlaying bone fragments that mayproduce severe pain, respiratory compromise, and chestwall deformity.Most of the fractured ribs are treated with conservativenon-operative care. These include aggressive pain mana gement (epidural analgesia, rib oral analgesics and/orbracing techniques), and ventilation and tracheotomy1until fibrous stabilization is achieved. These treatmentmethods have been shown to have good results in respect to restoration of the damaged chest wall, but havehigher chest infection and mortality rates compared tosurgical treatment.2More severe chest wall trauma is a major cause of morbidity and mortality, especially in the presence of a flailchest where paradoxical inward movement of the flailsegment in inspiration is found. Patients with flail chestoften require aggressive pain control, ventilation, andprolonged ICU stay.1About 10% of chest wall trauma cases result in a flailchest.4 Flail chest injuries, defined as fracture of at leastthree consecutive ribs in at least two locations each, areassociated with a mortality rate of up to 36%.3, 4 Flailchest injuries develop paradoxical inward movement ofthe flail segment which prevents effective inspirationand require prolonged mechanical ventilation which canlead to pneumonia and sepsis.32DePuy Synthes MatrixRIB Surgical TechniqueImage courtesy of Mario G. Gasparri, MD at MedicalCollege of Wisconsin, USA

The need to improve rib fracture treatment has beenreco gnized for many years and some surgeons havebeen using operative approaches including plates, intramedullary devices, vertical bridging, wire, sutures, andstruts to repair the chest wall.2, 3, 4, 5, 6, 7, 8, 9These attempts indicate a trend in better rib fracturetreatment to improve pain control, reduce duration of mechanical ventilation, reduce ICU stays, reduce the risk forchest wall deformities and ultimately improve patient care.MatrixRIB Surgical TechniqueDePuy Synthes3

BackgroundCHEST WALL DEFORMITYPectus Excavatum is the most common congenital chestwall deformity where the sternum is depressed. Anotherless common deformity of the sternum, known as PectusCarinatum, is where the sternum protrudes.Almost all patients with severe Pectus excavatum indicate that they have progressive symptoms of early fatigability, dyspnea, decreased endurance, tachycardia andtachypnea with physical exertion. With moderate-to-severe Pectus excavatum, the heart is often displaced intothe left chest and compressed, causing reduced strokevolume and cardiac output during exertion. Pulmonaryexpansion during inspiration is moderately confined, resulting in restriction, which often is noted on exercisepulmonary function tests. Physiologic impairment andreduced exercise capacity may be attributable to impaired cardiovascular performance rather than ventilatorlimitation.10Pectus excavatum repair has demonstrated significantimprovement in maximum voluntary ventilation, maximum oxygen utilization, and total lung capacity measured during exercise. Pectus excavatum repair that includes internal sternal support has been shown tominimize the occurrence of postoperative respiratory distress caused by paradoxical chest motion, to reducepain, to permit early ambulation and permit deeper respirations, and to maximize the extent to which thedefect is permanently corrected.10During most open surgical procedures, small sections ofdeformed costochondral cartilage are removed to freethe sternum laterally. A transverse wedge osteotomy isoften made in the sternum at the onset of the deformityto enable repositioning of the sternum into the correctanatomic position. Once approximated, the sternummust be fixated in place for the duration of the bonehealing process. Depending on the surgeon, fixation canoccur along the transverse sternotomy and/or laterallyfrom rib-to-rib along the sternum.4DePuy Synthes MatrixRIB Surgical Technique

CHEST WALL RESECTIONLarge resections of the chest wall, including the ribs, sternum, and/or surrounding soft tissue, are performed forthe curative and palliative treatment of malignant and benign tumors, radiation necrosis, and deep sternal woundinfections. Resections of defects greater than 5 cm in dia meter require skeletal reconstruction to maintain physiologic respiratory function and protect vital intrathoracicorgans.11 Paradoxical respiration may occur withoutproper stabilization causing pain, respiratory distress, andoften necessitating long term mechanical ventilation. Themain goals of reconstruction are: prevention of flail chest,maintenance of physiologic respiration, protection of thoracic organs, and an acceptable cosmetic result.11MatrixRIB Surgical TechniqueDePuy Synthes5

MRI INFORMATIONTorque, Displacement and Image Artifactsaccording to ASTM F 2213-06, ASTM F 2052-14 andASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRIsystem did not reveal any relevant torque or displacement of the construct for an experimentally measuredlocal spatial gradient of the magnetic field of 5.4 T/m.The largest image artifact extended approximately 35 mmfrom the construct when scanned using the GradientEcho (GE). Testing was conducted on a single SiemensPrisma 3 T MRI system.Radio-Frequency-(RF-)induced heating accordingto ASTM F2182-11aNon-clinical electromagnetic and thermal simulations ofworst case scenario lead to temperature rises of 21.7 C(1.5 T) and 12.4 C (3 T) under MRI conditions using RFCoils (whole body averaged specific absorption rate(SAR) of 2 W/kg for 15 minutes).Precautions: The above mentioned test relies onnon-clinical testing. The actual temperature rise inthe patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it isrecommended to pay particular attention to the following points: It is recommended to thoroughly monitor patientsundergoing MRI scanning for perceived temperature and/or pain sensations. Patients with impaired thermo regulation or temperature sensation should be excluded from MRIscanning procedures. Generally it is recommended to use an MRI systemwith low field strength in the presence of conductive implants. The employed specific absorptionrate (SAR) should be reduced as far as possible. Using the ventilation system may further contribute to reduce temperature increase in the body.6DePuy Synthes MatrixRIB Surgical Technique

INTENDED USE, INDICATIONS, CONTRAINDICATIONSAND WARNINGSIntended UseThe Synthes MatrixRIB Fixation System is intended forthe fixation and stabilization of rib and sternum fractures, fusions, and osteotomies of normal and osteoporotic bone and reconstructions of the chest wall.Pre-contoured Synthes MatrixRIB plates (04.501.00104.501.008) are intended for: Rib fracture fixations, osteotomies and reconstruction Rib-to-sternum fixationSynthes MatrixRIB straight plates (04.501.096,04.501.097) are intended for: Rib fracture fixations, osteotomies and reconstruction Rib-to-sternum fixation Transverse sternum reconstruction Transverse plating across the sternum (rib-to-rib) fixationThe Synthes MatrixRIB pre-contoured and straight platesare intended for temporary reconstruction, if they areused as implant spanning gaps after resection of ribsand/or sternum.IndicationsThe Synthes MatrixRIB Fixation System is indicated foruse in skeletally mature patients with normal or osteoporotic bone.Pre-contoured Synthes MatrixRIB plates (04.501.001 –04.501.008) are indicated for the fixation, stabilizationand reconstruction of: Rib fractures, fusions, osteotomies, and/or resections,including spanning gaps and/or defects Pectus Excavatum, Pectus Carinatum, and other chestwall deformitiesSynthes MatrixRIB straight plates (04.501.096 and04.501.097) are indicated for the fixation, stabilizationand reconstruction of: Rib and sternum fractures, fusions, osteotomies, and/orresections, including spanning gaps and/or defects Pectus Excavatum, Pectus Carinatum, and other chestwall deformitiesSynthes MatrixRIB sternal plates (04.501.068,04.501.069, 04.501.093, 04.501.094, 04.501.095,04.501.103, 04.501.104) are intended for: Sternum fracture fixations and osteotomiesSynthes MatrixRIB sternal plates, 2.8 mm thickness,(04.501.068, 04.501.069, 04.501.093, 04.501.094,04.501.095, 04.501.103, 04.501.104) are indicated forthe fixation, stabilization and reconstruction of: Sternum fractures, fusions, and/or osteotomies Pectus Excavatum, Pectus Carinatum, and other chestwall deformitiesThe Synthes MatrixRIB intramedullary splints(04.501.010, 04.501.011, 04.501.012) and the universalplate (04.501.009) are intended for rib fracture fixationsand osteotomies.The Synthes MatrixRIB intramedullary splints(04.501.010, 04.501.011, 04.501.012) and the universalplate (04.501.009) are indicated for the fixation and stabilization of ribs.MatrixRIB Surgical TechniqueDePuy Synthes7

Intended use, Indications, Contraindicationsand WarningsImportant: The Synthes MatrixRIB pre-contouredand straight plates are not indicated for use aspermanent implants for bridging gaps after chestwall resections.ContraindicationsThe MatrixRIB Fixation System is contraindicated for: The fixation of the sternum in acute cardiacpatients, due to the potential delay if emergentre-entry is required Screw attachment or fixation to the clavicle or spine Use in patients with latent or active infection,with sepsis, or who are unwilling or incapable offollowing postoperative care instructions.Warnings Metallic internal fixation devices cannot withstandactivity levels and/or loads equal to those placed onnormal healthy bone as these devices are not designedto withstand the unsupported stress of full weightbearing, load-bearing, or gap spanning which mayresult in fatigue failure of the device. Additionally, using the device for spanning gaps inpatients that put extreme strain on the implant (e.g.overweight or non-compliant) may further contributeto premature device failure. These devices can break intraoperatively whensubjected to excessive forces or outside the recommended surgical technique. While the surgeon mustmake the final decision on removal of the broken partbased on associated risk in doing so, we recommendthat whenever possible and practical for the individualpatient, the broken part should be removed. Medical devices containing stainless steel may elicit anallergic reaction in patients with hypersensitivity tonickel.8DePuy Synthes MatrixRIB Surgical Technique

Suggested* Clinical Applications for the MatrixRIB Fixation SystemApplicationPre-contouredPlates(1.5 mm)UniversalPlate(1.5 mm)uuStraight Plates Sternal Plates(1.5 mm)(2.8 mm)IntramedullarySplints(1.0 mm)TraumaRib FractureSternal FractureuuuuThoracotomyRib Osteotomy /latrogenic FractureuuuTransverse SternotomyuuChest Wall ReconstructionRib Reconstruction /ResectionsuuSternal Reconstruction /ResectionsuChest Wall Deformity RepairTransverse SternotomyRib Osteotomyuuuuu* Selection of plates should be based on individual patient anatomy, severity of injury/deformity, and surgeon preference.MatrixRIB Surgical TechniqueDePuy Synthes9

Intended use, Indications, Contraindicationsand WarningsGeneral Adverse EventsAs with all major surgical procedures, risks, side effectsand adverse events can occur. While many possible reactions may occur, some of the most common problemsresult from anesthesia and patient positioning (e.g.nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structuresincluding blood vessels, excessive bleeding, damage tosoft tissues incl. swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain,abnormal sensation due to the presence of the device,allergy or hyperreactions, side effects associated withhardware prominence, loosening, bending, or breakageof the device, mal-union, non-union or delayed unionwhich may lead to breakage of the implant, reoperation.Device Specific Adverse EventsDevice specific adverse events include but are not limited to:For chest wall reconstruction including spanning gaps: Plate breakage Pneumothorax Loss of chest wall stability Herniation Postoperative dehiscence Seroma Bone Necrosis and partial skin necrosisFor chest wall deformities: Residual or recurrent chest wall deformities Pleural effusions Seroma Hematoma11DePuy Synthes MatrixRIB Surgical Technique

MATRIXRIBFEATURES AND BENEFITSThe DePuy Synthes MatrixRIB Fixation System consists ofprecontoured, shaped, and straight locking plates,locking screws, and intramedullary splints for the fixationand stabilization of the chest wall. Designed to be used without removing periosteum tomaximize blood supply to the bone Drill bit with stop to prevent over-drilling Self-retaining screwdriver bladesPrecontoured plates Plates are precontoured to fit an average rib shape,which minimizes intraoperative bending3 Low profile, 1.5 mm thick plates Plates are color coded to distinguish left and rightdesigns Plates are etched on medial end to indicate thecorresponding rib curvatureRight plates(red rose)Locking holesIn-plane radiusR3R4-5Longitudinal twistR6-7R8-9Intramedullary splints Intramedullary splints allow less invasive procedures Three widths available (3 mm, 4 mm, 5 mm) Only one screw needed to secure splintLocking screws Locking design for increased stable fixation* Screws work with self-retaining screwdriver blades One screw diameter for use with all plates and splints* Mechanical test results may not be indicative of clinical performance.DePuy Synthes, Data on File. Rib Plate Evaluation under Exaggerated LoadingConditions. Mechanical Test Number: MT08-481.3Mohr M, Abrams E, Engel C, et al. (2007)MatrixRIB Surgical TechniqueDePuy Synthes11

MatrixRIBSternal plates Plates are shaped for sternal osteotomies and fractures 2.8 mm thickness for higher loads on sternal bodyR3R4-5R6-7R8-9rib 3rib 3rib 4rib 4rib 5rib 5rib 6rib 6rib 7rib 7rib 8rib 8rib 9rib 9L3T-PlateL4-5L6-7I-PlateL8-910 hole straightLeft plates(light blue)L3EtchingOut of plane radiusL4-5L6-7Tubular radiusL8-912DePuy SynthesMatrixRIBSurgical Technique

Universal/straight plates A universal plate with 8 holes is available for smallerfracture areas and osteotomies Straight plates with 24 or 30 holes are available forcomplex or custom bendsUniversal plate – 8 holes24 holes30 holesMatrixRIB Surgical TechniqueDePuy Synthes11

AO PRINCIPLESIn 1958, the AO formulated four basic principles, whichhave become the guidelines for internal fixation.*Anatomic reductionFracture reduction and fixation to restore functionalanatomical relationships.Stable fixationStability by rigid fixation or splintage, as the personalityof the fracture and the injury requires.Preservation of blood supplyPreservation of the blood supply to soft tissue and boneby careful handling and gentle reduction techniques.Early, active mobilizationEarly and safe mobilization of the part and patient.*  M. E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger.Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.11DePuy Synthes MatrixRIB Surgical Technique

PLATING RIB1Expose ribExpose the rib to allow a minimum of three screws oneach side of the fracture. Remove any nonviable bone.Removal of the periosteum is not required.Precaution: Avoid significant muscle division to preserve as much respiratory function as possible.MatrixRIB Surgical TechniqueDePuy Synthes11

Plating Rib2Determine rib thicknessInstrument03.501.074Universal CalliperOptional instrument03.501.065CalliperMake a small incision in the intercostal space at thesuperior border of the rib to allow insertion of the calliper tip. Insert the calliper tip through the incisionand determine the rib thickness.Precaution: Take care to avoid damaging the nerveand vessel bundle at the inferior border of the rib.Note: If an existing access into the intercostal spaceis available for measuring the rib thickness, it isrecommended to insert the calliper tip using theexis ting access.To select the appropriate drill bit with stop and theappropriate screw length, add 2 mm to the determinedrib thickness to allow for the plate thickness.11DePuy Synthes MatrixRIB Surgical Technique

3Approximate broken rib segmentsInstrument398.400 Reduction Forceps with Points, narrow,ratchet lock, length 132 mmUse the forceps to approximate the broken rib segments.4Cut and contour plate template (optional)Instrument03.501.090 MatrixRIB Bending Template, 30 holes,for Thoracic PlateCut the bending template to a length that allows placement of a minimum of three screws on each side of thefracture.Contour the template to the rib.MatrixRIB Surgical TechniqueDePuy Synthes11

Plating Rib5Select and cut plate (optional)Instrument03.503.057 Shortcut for MatrixMANDIBLE Plates,thickness 1.5 to 2.8, with RASP,required in pairsOptional Instrument391.990Cutting Pliers for Plates and RodsUse the bending template contoured in Step 4 to selectthe best matching plate.Notes: Position the precontoured plate with the etchingtoward the sternum Straight plates are available for use in place of aprecontoured plate (see Implants section)If necessary, cut the plate to the desired length.Precaution: Use a minimum of three screws on eachside of the fracture, to properly secure the plate.11DePuy Synthes MatrixRIB Surgical Technique

6Contour plate (optional)Instrument03.501.091MatrixRIB Bending PlierUsing the bending pliers, contour the plate to match thetemplate.Precaution: If contouring is necessary, avoid sharpbends, reverse bends, or bending the implant at ascrew hole. Avoid notching or scratching the implant. These factors may produce internal stresseswhich may become the focal point for eventualbreakage.MatrixRIB Surgical TechniqueDePuy Synthes11

Plating Rib7Position plateInstrument03.501.071MatrixRIB Plate Holding Forceps, smallOptional instruments03.501.030 MatrixRIB Plate Holding Forceps, small,with ball tip03.501.031 MatrixRIB Plate Holding Forceps, large,with ball tip03.501.704 Threaded Reduction Tool for MatrixRIB,with AO Quick Coupling(see page 48 for instructions)03.501.708 MatrixRIB Plate Holding Forceps,upright03.501.

according to ASTM F 2213-06, ASTM F 2052-14 and ASTM F2119-07 Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displace- ment of the construct for an experimentally measured local spatial gradient of the magnetic field of 5.4 T/m. The largest image artifact extended approximately 35 mm from the construct when scanned using the Gradient Echo .

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