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Technique Manual
IN001NFTM
Rev. C
08/04/2014
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Table of Contents
Table of Contents/Nota Bene/Note. . . . . . . . . . . . . . . 2
Features/Anatomic Areas. . . . . . . . . . . . . . . . . . . . . . 3
Surgical Technique. . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Cleaning/Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . 8
Parts List - Instruments. . . . . . . . . . . . . . . . . . . . . . . . 9
Parts List - Implants. . . . . . . . . . . . . . . . . . . . . . . . . 10
Important Medical Information . . . . . . . . . . . . . . . . . 11
Nota Bene
The technique description herein is made available to the healthcare professional to illustrate the author’s
suggested use. In the final analysis, the preferred use is under the surgeon’s discretion.
Note:
The N-Force Fixation System is cleared for use with ETEX Beta-bsm & ETEX CarriGen Structural Orthobiologic
Matrix (SOM) only. Refer to the package insert for Beta-bsm & CarriGen for more information.
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Features
Proprietary Injection Sheath
Reverse Cutting Flutes
Headless Screw Design
Helical Groove
Fully Cannulated Design
Titanium Alloy
Partially Cannulated Design
Anatomic Areas of Implantation
Anatomic areas include, but are not limited to: • Tibial plateau fractures
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•
Malleolar fractures
•
Tibial pilon fractures
•
Fractures of the calcaneus and talus
•
Fractures of the proximal humerus
•
Patellar fractures
•
Fractures of the distal humerus
•
Acetabular and pelvic fractures
•
Fractures of the distal radius
•
Proximal femoral fractures
•
Distal femoral fractures
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Surgical Technique 4.0mm
The following surgical technique is explained
using the example of a tibia plateau fracture.
Step 1 - Preoperative Radiographic Fracture Assessment and Planning
Assess the fracture pattern using radiographs and possibly a
CT scan. Determine the appropriate type of fixation to repair the
fracture and evaluate the need for Structural Orthobiologic Matrix
(SOM) (cleared for use with ETEX Beta-bsm® and CarriGen® by
ETEX Corp. only).
Step 2 - Intraoperative Fracture Assessment and Reduction
Assess the fracture utilizing fluoroscopy and/or direct visualization. Reduce the fracture and elevate any central
depression to reduce the articular fracture components. Provisionally stabilize the fracture as necessary with
K-Wires and/or clamps.
Step 3 - K-Wire Placement
Insert the K-Wire Guide (IN018-3) into the Drill Guide (IN018-2).
Using the combined Guides (IN018-3, IN018-2), place the 1.4mm
K-Wires (IN021-1) parallel to the joint line or in the surgeon’s
desired position for the N-Force Screw.
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Step 4 - Drilling of the Lateral Cortex
Remove the K-Wire Guide (IN018-3), leaving the Drill Guide
(IN018-2) in place. Drill lateral cortex with the 2.7mm Cannulated Drill (IN017-1) over the K-Wire (IN021-1), leaving
the K-Wire in place.
TECHNIQUE VARIATION: Use Tissue Protector (IN022-1) for
percutaneous insertion of the N-Force Screw.
Step 5 - Length Measurement
After confirming with C-arm Fluoroscopy that the 1.4mm
K-Wires (IN021-1) are in the correct position, remove the Drill
Guide (IN018-2) and measure each K-Wire using the Depth
Gauge (IN015-1). Use the measurement obtained to select the
appropriate length N-Force Screw.
50mm
50mm
50mm
50mm
5mm
55
50
45
50mm
10mm~13mm (The first fenestration from the head depends
on the length of the screw) 5mm
Step 6 - Assemble Sheath and Screw
Assemble the Sheath (IN003-1) onto the selected N-Force
Screw by turning the Sheath clockwise onto the threaded head
of the N-Force Screw and advance the Sheath until it fully covers
the head of the Screw.
TECHNIQUE VARIATION: A 4.0 Inset
Washer (IN043-1) may be used and requires
the use of the Inset Countersink (IN041-1)
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Step 7 - Attach the Cannulated Hex-Driver
Assemble the Driver Handle (IN023-1) and the Cannulated HexDriver (IN008-1) using the AO Quick Connect. Insert the Driver
Assembly into the Sheath (IN003-1) and engage the Screw
head with the Cannulated Hex-Driver (IN008-1).
TECHNIQUE VARIATION: For bi-cortical fixation and to prevent
SOM extrusion from the tip of the Screw into the soft tissue, an N-Force
Fixation System Partially Cannulated Screw is recommended. To use this
method, remove the K-Wire (IN021-1) and insert the correct size Partially
Cannulated Screw. Drive into the predrilled hole using the Solid HexDriver (IN002-1) for insertion until the tip of the Sheath (IN003-1) is flush
with the cortex. Skip to Step 10.
Step 8 - Insert N-Force Screw
Place Screw/Sheath assembly over the K-Wire (IN021-1) and
drive the N-Force Screw until the tip of the Sheath (IN003-1) is
flush with the cortex.
CAUTION: If Sheath (IN003-1) is not flush with the cortex, SOM may
leak around the bone/sheath interface.
TECHNIQUE TIP: Bone Wax applied around the bone/sheath interface
or fracture lines, if the bones are irregular or comminuted, can be used to
prevent leakage of SOM. Remove Bone Wax after SOM injection.
Step 9 - Remove Hex-Driver and K-Wire
Remove the Cannulated Hex-Driver (IN008-1) and K-Wire (IN021-1) from the Screw/Sheath assembly.
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Step 10 - Attach Syringe with pre-mixed SOM
Attach the Syringe with the pre-mixed SOM to the Sheath
(IN003–1). Using finger pressure, inject the SOM. Use fluoroscopy
to monitor the SOM as it fills the defect. Up to 5.0 cc can be
injected through each Screw to fill the void per surgeon’s discretion. Remove the Syringe from the Sheath (IN003-1).
TECHNIQUE TIP: The amount of SOM may vary depending on the size of
the defect and the anatomic area. N-Force Screws are intended for single injection. If further filling of the defect is required, insertion of additional N-Force
Screws may be necessary.
Step 11 - Plunge and loosen the Sheath
Assemble the Solid Hex-Driver (IN002-1) and the Driver Handle
(IN023-1) using the AO Quick Connect. Push the Solid Hex-Driver
(IN002-1) through the entire length of the Sheath (IN003-1) to
plunge the Sheath (IN003-1) of the remaining SOM and engage
the Screw. With the Solid Hex-Driver (IN002-1) engaged into the
Screw, turn the Sheath (IN003-1) counterclockwise and disconnect
from the Screw head. Slide the Sheath (IN003-1) up the shaft of the
Solid Hex-Driver (IN002-1).
CAUTION: Do NOT use the Cannulated Hex-Driver (IN008-1) to plunge the
Sheath (IN003-1) as it will fill with the SOM and may clog the instrument.
Step 12 - Fully seat the N-Force Screw
With the Solid Hex-Driver (IN002-1) engaged into the head of the Screw, seat the Screw down to make flush with
the cortex of the bone. Remove the Solid Hex-Driver (IN002-1) and Sheath (IN003-1). Typically, 1-3 Screws are used
to stabilize the fracture and inject the SOM.
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Cleaning
The N-Force Fixation System Instruments must be thoroughly cleaned prior to sterilization. Decontamination and disinfection of the instruments should occur immediately after completion of the surgical procedure. Failure to
properly clean the instruments may lead to inadequate sterilization.
Preparation for Cleaning: Disassemble the instruments, where possible. Remove gross soil with paper wipes or
surgical towels.
Manual Cleaning: Prepare an enzymatic cleaning solution in the concentration and at the temperature specified in
the detergent manufacturer’s instructions. Immerse the instruments in the cleaning solution for a minimum
of 15 minutes. Activate any instrumentation while immersed. Use a brush adequate for cleaning medical
devices or cleaning wires to clean the instruments. Pay special attention to rough surfaces and features
(lumens, cannulations, hinges, threads, joints, etc.) which may be shielded from brushing and retain additional soil. It may be necessary to use a cleaning wire or syringe to flush cannulations/lumens. Rinse the
instruments in purified/de-ionized water for at least one minute. Visually examine the instruments for soil. If
soil remains, repeat the Manual Cleaning process until no soil is visible.
Mechanical Cleaning: Pre-clean the instruments according to the Manual Cleaning process detailed above. Prepare
an enzymatic cleaning solution in the concentration and at the temperature specified in the detergent
manufacturer’s instructions. Immerse the instruments in an Ultrasonic bath and activate the bath for at least
the time specified in the detergent manufacturer’s instructions. Rinse the instruments in purified/de-ionized
water for at least one minute. Visually examine the instruments for soil. If soil remains, repeat the Mechanical
Cleaning process until no soil is visible.
Inspect the instrument tray for soil. If soil is visible, clean per the process detailed above. If there will be a
delay between cleaning and further processing, thoroughly dry the instruments and tray using paper wipes or
compressed air. Reassemble the N-Force Fixation System Instruments in the tray before sterilization.
Sterilization
Instruments:
The N-Force Fixation System Instruments are provided non-sterile. Sterilization must be performed prior to
surgery using the following method:
Prevacuum- wrapped in two layers of 1-ply polypropylene wrap using sequential wrapping techniques.
Processed at 270˚F (132˚C) for 4 minutes with 30 minutes dry time.
Screws, Washers and Sheaths:
The N-Force Fixation System Screws, Washers, and Sheaths are provided sterile and have been packaged in
protective packaging. Inspect package for punctures or other damage before opening onto a sterile operative field.
The N-Force Fixation System Screws, Washers, and Sheaths are single-use only and CANNOT be resterilized.
The N-Force Fixation System Sheath is designed for introduction of cleared SOMs into the Screw and is NOT for
implantation.
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Parts List - 4.0mm Instruments
N-Force Fixation System Solid Hex-Driver Part# IN002-1
N-Force Fixation System Cannulated Hex-Driver Part# IN008-1
N-Force Fixation System Depth Gauge Part# IN015-1
N-Force Fixation System 2.7mm Cannulated Drill
Single-Use Only *
Part# IN017-1
N-Force Fixation System Countersink Part# IN041-1
N-Force Fixation System Drill Guide Part# IN018-2
N-Force Fixation System K-Wire Guide Part# IN018-3
N-Force Fixation System 1.4mm K-Wire Single-Use Only *
Part# IN021-1
N-Force Fixation System Tissue Protector Part# IN022-1
N-Force Fixation System Driver Handle Part# IN023-1
*The N-Force Fixation System 2.7mm Cannulated Drill (IN017-1) and 1.4mm
K-Wire (IN021-1) are single-use only and CANNOT be resterilized after use.
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Parts List - 4.0mm Implants
N-Force Fixation System Partially Cannulated
Screw & Sheath
IN001-25-FS 4.0mm x 25mm N-Force Fixation PC Screw & Sheath
IN001-30-FS 4.0mm x 30mm N-Force Fixation PC Screw & Sheath
IN001-35-FS 4.0mm x 35mm N-Force Fixation PC Screw & Sheath
IN001-40-FS 4.0mm x 40mm N-Force Fixation PC Screw & Sheath
IN001-45-FS 4.0mm x 45mm N-Force Fixation PC Screw & Sheath
IN001-50-FS 4.0mm x 50mm N-Force Fixation PC Screw & Sheath
IN001-55-FS 4.0mm x 55mm N-Force Fixation PC Screw & Sheath
IN001-60-FS 4.0mm x 60mm N-Force Fixation PC Screw & Sheath
IN001-65-FS 4.0mm x 65mm N-Force Fixation PC Screw & Sheath
IN001-70-FS 4.0mm x 70mm N-Force Fixation PC Screw & Sheath
IN001-75-FS 4.0mm x 75mm N-Force Fixation PC Screw & Sheath
N-Force Fixation System Fully Cannulated
Screw & Sheath
IN006-25-FS 4.0mm x 25mm N-Force Fixation FC Screw & Sheath
IN006-30-FS 4.0mm x 30mm N-Force Fixation FC Screw & Sheath
IN006-35-FS 4.0mm x 35mm N-Force Fixation FC Screw & Sheath
IN006-40-FS 4.0mm x 40mm N-Force Fixation FC Screw & Sheath
IN006-45-FS 4.0mm x 45mm N-Force Fixation FC Screw & Sheath
IN006-50-FS 4.0mm x 50mm N-Force Fixation FC Screw & Sheath
IN006-55-FS 4.0mm x 55mm N-Force Fixation FC Screw & Sheath
IN006-60-FS 4.0mm x 60mm N-Force Fixation FC Screw & Sheath
IN006-65-FS 4.0mm x 65mm N-Force Fixation FC Screw & Sheath
IN006-70-FS 4.0mm x 70mm N-Force Fixation FC Screw & Sheath
IN006-75-FS 4.0mm x 75mm N-Force Fixation FC Screw & Sheath
N-Force Fixation System Washer
IN043-1
IN001NFTM
N-Force 4.0 Inset Washer
Rev. C
08/04/2014
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Notes
IN001NFTM
Rev. C
08/04/2014
11
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1975 Nonconnah Boulevard
Memphis, TN 38132
www.innovisionus.com
Toll Free (877) 664-8370
Telephone (901) 370-5700
Facsimile (901) 369-9480
orders@innovisionus.com
©2014 InnoVision Inc. All rights reserved.
The N-Force Fixation System is a registered trademark of InnoVision Inc.
Patented US 8,574,273
Other Patents Pending
IN001NFTM
Rev. C
08/04/2014