SURGICAL TECHNIQUE · 2019-08-27 · additional screws, if required. 16. The k-wire is removed and...

FO Micro Screw System

SURGICAL TECHNIQUE

375 Wickham Terrace

Spring Hill

QLD 4000

Australia

[email protected]

www.fieldorthopaedics.com

Product Overview

Need ...................................................................................... 3

Micro Screw System ...............................................................4

Indications and Contraindications .......................................... 5

Design Features and Benefits ................................................ 6

Surgical Technique

1.5 mm and 2.0 mm Cannulated Micro Screw .......................... 7

Catalogue Information

Implants ................................................................................ 12

Instruments .......................................................................... 13

Kits ....................................................................................... 16

System .................................................................................. 17

TABLE OF CONTENTS

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PROBLEMThe management of small fractures is difficult. The small size, fragile structure, and the importance of accurate reduction is challenging with traditional systems. Current practice sees the surgeon reducing these injuries with clamps and forceps while attempting to maintain the position, drilling, countersinking, and inserting solid core screws.

IMPACTThe lack of supporting devices makes the achievement of initial reduction and maintenance of the correct orientation very problematic. This complexity can put the patient at risk, prolong operative time and increase the chance of complications.

INNOVATIONThe Field Orthopaedics Micro Screw System is designed to make the management of extremity fractures better. With a complete redesign that both increases the implant strength at a smaller scale and accommodates for cannulated precision, the System allows the surgeon to accurately reduce the fragment with small diameter k-wires and hold the bone in place during the single shot insertion of a definitive implant.

The Field Orthopaedics Micro Screw System is built on the values of precision and strength. With a design that accomodates a simpler, faster repair, the Field Orthopaedics Micro Screw offers an innovative solution to the shortcomings of the management of extremity fractures.

NEED

PRODUCT OVERVIEW

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The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.

FO MICRO SCREW KITThe Field Orthopaedics Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm in 1 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.

FO PIN AND K-WIRE KITThe FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.

IMPLANT MATERIALSRefer to the package label for the materials.

All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).

All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).

The instrumentation is made from medical grades stainless steel, anodized aluminium and marked with epoxy resin. Refer to the package label for the materials.

MICRO SCREW SYSTEM

PRODUCT OVERVIEW

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INDICATIONS FOR USEThe Field Orthopaedics Micro Screw System consists of the following kits with the following indications:

The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.

The FO Pin and Wire Kit is intended for fixation and stabilization of bone fractures or as guidance at insertion of implants into the skeletal system.

CONTRAINDICATIONSUse of the Field Orthopaedics Micro Screw System is contraindicated in; cases of inflammation, cases of active or suspected sepsis / infection and osteomyelitis; or in patients with certain metabolic diseases.

All applications that are not defined by the indications are contraindicated. In addition, surgical success can be adversely affected by:

• Acute or chronic infections, local or systemic;• Osteopathies with reduced bone substance that could affect the function of the

implant;• Known or suspected sensitivity to metal; and• Whenever the use of the implant comes into conflict with the anatomical structures of

physiological status.Other medical or surgical preconditions that could compromise the potentially beneficial procedure, such as:

• Immunosuppressive pathologies;• Increased sedimentation rates that cannot be explained by other pathologies;• Increased leukocyte (WBC) count, and;• Pronounced left shift in the differential leukocyte count.

INDICATIONS AND CONTRAINDICATIONS

PRODUCT OVERVIEW

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• Narrow shaft • Low profile head design for maximum compression• Custom cutting flutes

• Precision tolerances to facilitate an interference capture• Reinforced driver interface for maximum torque generation and strength

DESIGN FEATURES AND BENEFITS

• Cannulated for precision insertion

PRODUCT OVERVIEW

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REDUCTION AND PREPARATION OF FRACTURE SITE1. Preoperative planning of approach and fixation based on the fracture configuration.2. The surgical approach is made with minimal soft tissue stripping.

3. Reduction of the fracture fragments with preferred technique. 4. Suitably sized pins and k-wires from the accompanying FO Pin and K-wire Kit may be

used at the surgeon’s discretion in keeping with standard practices.Note: The pins and k-wires may be left in for definitive fixation or a cannulated screw used over the wire.

5. Preparation for screw insertion is achieved with the FO 0.6 mm k-wires through both fragments until it pierces the far cortex. Confirm positioning under fluoroscopy.

Note: If required, the Soft Tissue Protector and/or Soft Tissue Protector Sleeve can be used to guide the k-wire during insertion.

1.5 & 2.0 FO MICRO SCREW

SURGICAL TECHNIQUE

8

1.5 & 2.0 FO MICRO SCREW CONT'D

MEASUREMENT6. Slide the Depth Gauge over the k-wire until the tip is in contact the proximal bone

surface.7. Screw length is selected from Depth Gauge measurement with the appropriate

diameter selected based on the fragment size, position and eventual fixation construct planned.

8. Length of insertion measurement is taken from the "0" of the FO Micro Depth Gauge, to the the rounded, proximal end of the k-wire.

DRILLING AND COUNTERSINKING - OPTIONAL9. A pilot hole is required to be drilled over the wire with the correct size cannulated drill.

The 1.1mm Cannulated Drill Bit should be used with the 1.5 mm Cannulated Micro Screws and the 1.4 mm Cannulated Drill Bit should be used with the 2.0 mm Cannulated Micro Screws.

10. Compatible FO quick-coupling instruments are connected with the FO Surgical Handle by inserting the proximal end of the bit into the receiving end of the handle whilst pulling back on the black, center portion in the direction marked "RELEASE". The flat portion of the instrument must align with the "FLAT" label on the handle. The bit will lock once fully insterted and the center portion of the handle is released.

Note: To remove FO Quick-coupling instruments from the handle, pull back the center portion of the handle and pull the instrument out.

SURGICAL TECHNIQUE

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11. If required, first place the Drill Guide over the k-wire and drill through the guide to ensure accuracy and protection of surrounding tissue.

12. If countersinking is considered necessary, the Cannulated Countersink is passed over the wire and driven into the proximal bone surface to the appropriate laser mark for the screw head size.

Note: In articular cartilage, soft bone or in the case of the small head size inserted perpendicular to the surface, countersinking may not be necessary.

SCREW INSERTION13. Definitive fixation is achieved by using the 1.5 Hex Driver and FO Handle to drive the

correct screw over the K-wire.

SURGICAL TECHNIQUE

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14. The screw should be tightened until the desired compression has been reached using the thumb and index finger, taking care not to strip the thread.

15. Confirm screw position under fluoroscopy before repeating steps 6-15 to place additional screws, if required.

16. The k-wire is removed and the operative site is closed in the surgeons preferred method.

SURGICAL TECHNIQUE

IMPLANT REMOVALIn case the physician decides to remove the implants, the implants can be removed by using general surgical instruments.

CATALOGUEINFORMATION

12

1.5 FO MICRO SCREW

1.5 MM CANNULATED PARTIALLY THREADED COMPRESSION SCREWSMaterial: Titanium Alloy (ASTM F136)

LENGTH DISTAL THREAD LENGTH CATALOG NUMBER

6 MM 2MM MSCP-0615

7 MM 2MM MSCP-0715

8 MM 3 MM MSCP-0815

9 MM 3 MM MSCP-0915

10 MM 3 MM MSCP-1015







2.0 FO MICRO SCREW

2.0 MM CANNULATED PARTIALLY THREADED COMPRESSION SCREWSMaterial: Titanium Alloy (ASTM F136)

LENGTH DISTAL THREAD LENGTH CATALOG NUMBER

6 MM 2MM MSCP-0620

7 MM 2MM MSCP-0720

8 MM 3 MM MSCP-0820

9 MM 3 MM MSCP-0920








CATALOGUE INFORMATION

IMPLANTS

13

FO GUIDE SLEEVES

Material: Stainless Steel

DESCRIPTION CATALOG NUMBER

FOR 0.6 MM K-WIRE, COUPLE WITH FO SOFT TISSUE PROTECTOR FOGS-0006




FOR 1.6 MM PIN, COUPLE WITH FO SOFT TISSUE PROTECTOR FOGS-0016

FOR 2.0 MM PIN, COUPLE WITH FO SOFT TISSUE PROTECTOR FOGS-0020


PINS AND KIRSCHNER WIRES, TROCARMaterial: Stainless Steel (ASTM 138)

Ø LENGTH DESCRIPTION CATALOG NUMBER

0.6 MM 70 MM SINGLE-ENDED TROCAR KWST-0706

0.6 MM 70 MM DOUBLE-ENDED TROCAR KWDT-0706

0. 8 MM 70 MM DOUBLE-ENDED TROCAR KWDT-0708





IMPLANTS AND INSTRUMENTS

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FO MICRO DRILL, CANNULATEDMaterial: Stainless Steel

Ø DESCRIPTION CATALOG NUMBER

1.1 MM FOR 1.5 FO MICRO SCREW, QUICK COUPLING, BLUE MSDR-1115

1.4 MM FOR 2.0 FO MICRO SCREW, QUICK COUPLING, GOLD MSDR-1420

FO MICRO DRIVER, CANNULATEDMaterial: Stainless Steel


HEX, FOR ALL FO MICRO SCREWS, QUICK COUPLING MSHX-0000


FO MICRO COUNTERSINK, CANNULATEDMaterial: Stainless Steel


FOR ALL 1.5 AND 2.0 FO MICRO SCREWS MSCK-0000

FO MICRO CLEANING STYLETMaterial: Stainless Steel


0.6MM DIAMETER, ROUNDED END MSST-0000

INSTRUMENTS

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FO MICRO DEPTH GAUGE, CANNULATED

Material: Aluminium


0.6 MM, LIGHTWEIGHT, ERGONOMIC DESIGN MSDG-0000


FO SOFT TISSUE PROTECTORMaterial: Stainless Steel


FOR ALL GUIDE SLEEVES, ERGONOMIC DESIGN MSTP-0000

FO SURGICAL HANDLE, CANNULATEDMaterials: Aluminium, Stainless Steel


FOR ALL FO QUICK COUPLING INSTRUMENTS MSHD-0000

INSTRUMENTS

16


FO MICRO SCREW KIT FMSK-0000

IMPLANTS AND INSTRUMENTS

CATALOG NUMBER DESCRIPTION QUANTITY

MSCP-0615 1.5 FO MICRO SCREW 6MM (CANNULATED) 5






















KWST-0706 0.6 SINGLE-ENDED TROCAR K-WIRE 70MM 10

MSDG-0000 FO MICRO DEPTH GAUGE (CANNULATED) 1

MSDR-1115 1.1 FO MICRO DRILL (CANNULATED) 3

MSDR-1420 1.4 FO MICRO DRILL (CANNULATED) 3

MSCK-0000 FO COUNTERSINK (CANNULATED) 1

MSST-0000 FO MICRO CLEANING STYLET 1

MSHX-0000 FO MICRO HEX DRIVER (CANNULATED) 2

MSHD-0000 FO SURGICAL HANDLE, QUICK COUPLING 1

MSTP-0000 FO SOFT TISSUE PROTECTOR 1

FOGS-0006 0.6 FO GUIDE SLEEVE 1

KITS

17


FO PIN AND K-WIRE KIT FKWK-0000

IMPLANTS AND INSTRUMENT


KWDT-0706 0.6 DOUBLE-ENDEDED TROCAR K-WIRE 70MM 10

KWDT-0708 0.8 DOUBLE-ENDED TROCAR K-WIRE 70MM 10



KWDT-1516 1.6 DOUBLE-ENDED TROCAR PIN 150MM 10

KWDT-1520 2.0 DOUBLE-ENDED TROCAR PIN150MM 10







FO MICRO SCREW SYSTEM FMSS-0000

Kits


FMSK-0000 FO MICRO SCREW KIT 1

FKWK-0000 FO PIN AND K-WIRE KIT 1

KITS AND SYSTEM

375 Wickham Terrace

Spring Hill

QLD 4000

Australia

[email protected]

wwwfieldorthopaedics.com

FOSCR1_TD-008-06 Issuance Date: 2018-08-22Product Leaflet and Surgical Technique

SURGICAL TECHNIQUE · 2019-08-27 · additional screws, if required. 16. The k-wire is removed and...

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