1. No category

TM
Ankle
With a non sterile
standard kit
Calling on medical staff
Co nt raint s
Complex
traceability
Contracted out
sterilization
Suppliers’
deadline
H i gh co s t s
Com p lex p ro cess
1
Stocks
Delivery
Control
5
Cleaning
Decontamination
Decontamination
HOSPITAL
Sterilization
9
Surgeon
6
7
8
Drying
Control
12
10
11
13
14
15
Restocking
4
Control
Cleaning
Sterilization
17
Incomplete
kit
Kit incomplet
3
Unpacking
Packaging
of the kit
Cleaning
Bulky storage
2
Storage
Drying
18
Packaging of
the kit
Surgery
Decontamination
16
Control
Traceability
19
20
Sterilization
Storage
Prevents an
effective solution &
a quick response
Defective
sterilization
Incomplete
kit
Damaged
instrumentation
INCREASED
RISKS
NON OPTIMIZED
surgery
URGENT SURGICAL CASES
COMPROMISED
With the
™
S a fe t y
T
OU
ESH OX
FR THE B
OF
TRACEABILITY
Cos t e f f ic ie nc y
Risk
of contamination
kit
Effic ien c y
1
Delivery
Controlled stocks
Simplified control
Cleaning
Decontamination
Sterilization
Surgeon
2
Storage
3
Surgery
An effective
solution &
a quick response
Availab le wh en
n eeded
Hospital
Sundry
expenses
READY-TO-USE FOR
SURGERY
Optimized handling of
URGENT SURGICAL CASES
Optimized storage
with state-of-the-art implants
Safety:
The Initial A™ kits are fully traceable and
have a shelf life of 5 years.
Its instrumentation and implants are
always “fresh out of the box” and have
never been opened or used before.
Available when needed:
The Initial A™ kits (Initial A™ - Fibula and
Initial A™- Syndesmosis) come pre-sterilized
and ready to use.
The combination of sterile implants and
single use instrumentation in a single
packaging makes Initial A™ ideal for use in
urgent surgical cases.
™
innovation
Storage:
Initial A™ kits can be easily stored in the
operating room because of its small size.
Costs:
Contamination:
Initial A™ is a cost-effective solution.
The additional costs including cleaning,
decontamination, sterilization of kits are
cancelled.
The combination of sterile implants
and sterile single-use instrumentation
minimizes contamination risks.
Buying procedure:
Initial A™ facilitates buying procedures:
restocking and orders are simplified, stock
management is optimized.
Initial A™- Fibula kits
Initial A™ - Fibula kits are intended for the fixation of fractures, osteotomies, pseudarthroses of the distal fibula in adults.
Initial A™ - Syndesmosis kit is intended for syndesmotic repair in adults.
Contra-indications
• Pregnancy.
• Acute or chronic, local or systemic infections.
• Lack of musculo-cutaneous cover, severe vascular deficiency touching the focus.
• Insufficient bone quality preventing a good fixation of the screws into the bone.
• Muscular deficit, neurological deficiency or behavioural disorders which could submit the osteosynthesis to abnormal mechanical strains.
• Foreign body sensitivity or allergy to one of the materials used.
• Patients with mental or neurological conditions who are unwilling or incapable of following post-operative care instructions.
• Patients with poor physical condition and/or mental instability.
(Please refer to the instructions for use for the complete list of the warnings, precautions, contra-indications and possible adverse effects. )
97 mm
A precontoured implant
128 mm
75 mm
Technical features
Indications
Angular range: +/- 10°
polyaxial locking fixation
Newclip Technics plates combine both polyaxial and locking
technologies to create a fixed-angle construct particulary useful
for poor bone quality and/or multifragmentary fractures.
Kits available for 3 sizes of plate
Plates for left side (blue)
Plates for right side (green)
Ø3.5 mm locking screw
Monoaxial hole
Optimized anatomical congruence
The design of this implant is the result of a proprietary stateof-the-art mapping technology to establish an optimized
congruence between the plate and the bone.
Ø3.5 mm cortical screw
Oblong hole
+/- 10°
angle
The implant also offers bendable areas which allow an optimum
adjusting of the plate on the diaphyseal part and on the junction
of the diaphysis and epiphysis parts thanks to the bending pliers.
(Possibility to order bending pliers separately)
Syndesmosis fixation
Ø3.5 mm cortical screw
or Ø4.0 mm lag screw
Dualtec System® II
technology
Clip + nut
Bending area
Ø2.8 mm locking screw
Monoaxial hole
Ø2.8 mm locking screw
Polyaxial hole
Ø3.5 mm locking screw
SOT3.5Lxx
Ø3.5 mm cortical screw
CT3.5Lxx
Ø2.8 mm locking screw
SDT2.8Lxx
Ø4.0 mm lag screw
QT4.0Lxx
Monoaxial locking system
- The threaded sections under the screw head and
inside the hole have strictly the same characteristics (1),
- Screw head cap (2),
- Plate and screw made from the same material:
titanium alloy.
1
1
2
Construct limiting cold welding risks for
improved removal properties.
Initial A - Fibula kits
Size 3
™
Surgical technique
Size 2
Size 1
1. Using the template (ANC607), define the
appropriate plate size, then determine the
appropriate kit.
2. Drill using the Ø2.7 mm drill bit.
3. When a lag effect is necessary, widen the
drilling made in the anterior cortex only, using
the countersink part of the blue 2-in-1 instrument
(Ø3.5 mm).
4. Insert the Ø3.5 mm interfragmentary cortical
screw using the screwdriver part of the blue 2-in1 instrument.
5. Temporarily hold the plate with two K-wires
inserted through the distal holes in the plate.
6. The plate is securely placed using a nonlocking Ø3.5 mm light blue cortical screw in the
most distal oblong screw hole.
7. Using the Ø2.0 mm guide gauge (grey), choose
the angle of the Ø2.8 mm screws in the polyaxial
holes then drill (Ø2.0 mm) and measure the screw
length directly on the gauge.
8. Using the grey screwdriver (for Ø2.8 mm
screws) insert and lock the distal screws.
N.B.: The template can be used both for the right side and for
the left side. Available sterile separately.
The 2-en-1
instrument
(ANC543)
The 2-en-1 instrument includes the
2 following functions:
- S
crewdriver for Ø3.5 mm and
Ø4.0 mm screws,
- Reamer to widen the drilling
made in the cortex before screw
insertion.
Final result
Final result
Or
9. Using the Ø2.7 mm guide gauge (blue) (for
Ø3.5 mm screws), drill (Ø2.7 mm) and measure
the screw length directly on the gauge.
9. bis. In the case of bicortical screws, the drilling
depth can be measured by inserting the depth
gauge through the guide gauge.
10. Using the countersink part of the blue
2-in-1 instrument, widen the anterior cortex.
Insert a blue screw (Ø3.5 mm screw) using the
screwdriver part of the blue 2-in-1 instrument
and lock it.
Repeat steps #9 and #10 to insert the
remaining Ø3.5 mm screws in the plate.
Initial A™- Fibula kits
References
INITIAL A™ - FIBULA KITS
INITIAL A™ - FIBULA KITS - IMPLANTS CONTENT
QUANTITY PER KIT
Ref.
Description
Ref.
Description
KIT-AL1D
Distal fibula kit - Standard lateral plate - Right - Size 1
RTL1D
Lateral plate - Standard - Right - S1
1
-
-
-
-
-
KIT-AL1G
Distal fibula kit - Standard lateral plate - Left - Size 1
RTL1G
Lateral plate - Standard - Left - S1
-
1
-
-
-
-
KIT-AL2D
Distal fibula kit - Standard lateral plate - Right - Size 2
RTL2D
Lateral plate - Standard - Right - S2
-
-
1
-
-
-
KIT-AL2G
Distal fibula kit - Standard lateral plate - Left - Size 2
RTL2G
Lateral plate - Standard - Left - S2
-
-
-
1
-
-
KIT-AL3D
Distal fibula kit - Standard lateral plate - Right - Size 3
RTL3D
Lateral plate - Standard - Right - S3
-
-
-
-
1
-
KIT-AL3G
Distal fibula kit - Standard lateral plate - Left - Size 3
RTL3G
Lateral plate - Standard - Left - S3
-
-
-
-
-
1
SDT2.8L10
Ø2.8 mm locking screw - L 10 mm
1
1
1
1
1
1
SDT2.8L12
Ø2.8 mm locking screw - L 12 mm
1
1
1
1
1
1
INITIAL A™ - FIBULA KIT - INSTRUMENTATION CONTENT
KIT-AL1D KIT-AL1G KIT-AL2D KIT-AL2G KIT-AL3D KIT-AL3G
Ref.
Descrpition
SDT2.8L14
Ø2.8 mm locking screw - L 14 mm
2
2
2
2
2
2
ANC437
Guide gauge Ø2.0 mm for locking screws
SDT2.8L16
Ø2.8 mm locking screw - L 16 mm
2
2
2
2
2
2
ANC540
Ø2.0 mm QC drill bit - L 125 mm
SDT2.8L18
Ø2.8 mm locking screw - L 18 mm
2
2
2
2
2
2
ANC541
Ø2.7 mm QC drill bit - L 125 mm
SOT3.5L12
Ø3.5 mm locking screw - L 12 mm
1
1
2
2
3
3
ANC543
2 in 1: 2.5 mm hexagonal prehensor screwdriver - Ø3.5 mm reamer
SOT3.5L14
Ø3.5 mm locking screw - L 14 mm
2
2
2
2
3
3
ANC544
Ø2.7 mm locking guide gauge
SOT3.5L16
Ø3.5 mm locking screw - L 16 mm
1
1
1
1
1
1
ANC545
Length gauge
CT3.5L12
Ø3.5 mm cortical screw - L 12 mm
1
1
1
1
1
1
ANC549
2.0 mm hexagonal prehensor screwdriver
CT3.5L14
Ø3.5 mm cortical screw - L 14 mm
1
1
1
1
2
2
33.0214.120
Pins - Ø1.4 L120 mm (x2)
CT3.5L16
Ø3.5 mm cortical screw - L 16 mm
-
-
1
1
1
1
CT3.5L18
Ø3.5 mm cortical screw - L 18 mm
1
1
1
1
1
1
CT3.5L20
Ø3.5 mm cortical screw - L 20 mm
1
1
1
1
1
1
NB : Supplemental screws are available in sterile package (cf : Initial A™ additional kits, additional
implants).
Initial A™Syndesmosis kit
Initial A™ - Syndesmosis kit is intended for the temporary fixation of the syndesmosis injuries combined with distal fibula fractures in adults.
Surgical technique
Final result
b
a
1. The syndesmodic screw can be inserted
in the 2 following holes:
a. The most distal diaphyseal hole,
b. The most distal oblong hole.
References
2. Place the guide gauge in the holes
designed for syndesmotic screw. The
drilling depth can be directly measured on
the gauge.
Description
KIT-AMS
Syndesmosis kit
Ref.
Description
ANC546
NB: The syndesmotic screw must be removed using the removal
kit Initial A™ (ref : KIT-REMOVE-A) once the syndesmosis has
healed, usually after six to eight weeks.
Sterile screws packaged in the Syndesmosis Supplemental sterile
screw caddy:
INITIAL A™ - SYNDESMOSIS KIT
Ref.
Insert the syndesmodic screw and finalize the
tightening with the blue 2-in-1 instrument from
Initial A™ – Fibula kit.
STERILE SCREWS FOR INITIAL A™ - SYNDESMOSIS KIT*
INITIAL A™ - SYNDESMOSIS KIT CONTENT
Ref.
Description
Qty
CT3.5L40-ST
Ø3.5 mm cortical screw - L 40 mm - sterile
2
Qty
CT3.5L45-ST
Ø3.5 mm cortical screw - L 45 mm - sterile
3
Ø2.7 mm quick coupling drill bit - L 180 mm
1
CT3.5L50-ST
Ø3.5 mm cortical screw - L 50 mm - sterile
3
ANC547
Ø2.7 mm non-locking guide gauge
1
CT3.5L55-ST
Ø3.5 mm cortical screw - L 55 mm - sterile
3
ANC548
2.5 mm hexagonal quick coupling screwdriver
1
CT3.5L60-ST
Ø3.5 mm cortical screw - L 60 mm - sterile
2
WASH-T4
Compression washer
2
CT3.5L65-ST
Ø3.5 mm cortical screw - L 65 mm - sterile
2
QT4.0L40-ST
Ø4.0 mm lag screw - L 40 mm - sterile
3
QT4.0L45-ST
Ø4.0 mm lag screw - L 45 mm - sterile
3
QT4.0L50-ST
Ø4.0 mm lag screw - L 50 mm - sterile
3
QT4.0L55-ST
Ø4.0 mm lag screw - L 55 mm - sterile
3
QT4.0L60-ST
Ø4.0 mm lag screw - L 60 mm - sterile
3
QT4.0L65-ST
Ø4.0 mm lag screw - L 65 mm - sterile
3
CT3.5Lxx : Anodized in light blue
QT4.0Lxx : Not anodized
*
Initial A™ - Additional kits
References
Additional implants
Sterile screws packaged in the Supplemental sterile screw caddy:
Ø2.8 mm LOCKING SCREWS*
Ref.
Description
SDT2.8L10-STI
Ø2.8 mm locking screw - L 10 mm - sterile
SDT2.8L12-STI
SDT2.8L14-STI
Ø3.5 mm LOCKING SCREWS*
Qty
Ref.
Description
1
SOT3.5L10-ST
Ø3.5 mm locking screw - L 10 mm - sterile
Ø2.8 mm locking screw - L 12 mm - sterile
1
SOT3.5L12-ST
Ø2.8 mm locking screw - L 14 mm- sterile
1
SOT3.5L14-ST
Ø3.5 mm CORTICAL SCREWS*
Qty
Ref.
Description
Qty
2
CT3.5L10-ST
Ø3.5 mm cortical screw - L 10 mm - sterile
2
Ø3.5 mm locking screw - L 12 mm - sterile
1
CT3.5L12-ST
Ø3.5 mm cortical screw - L 12 mm - sterile
1
Ø3.5 mm locking screw - L 14 mm - sterile
1
CT3.5L14-ST
Ø3.5 mm cortical screw - L 14 mm - sterile
1
Ø3.5 mm cortical screw- L 16 mm - sterile
1
SDT2.8L16-STI
Ø2.8 mm locking screw - L 16 mm - sterile
1
SOT3.5L16-ST
Ø3.5 mm locking screw - L 16 mm - sterile
1
CT3.5L16-ST
SDT2.8L18-STI
Ø2.8 mm locking screw - L 18 mm - sterile
1
SOT3.5L18-ST
Ø3.5 mm locking screw - L 18 mm - sterile
2
CT3.5L18-ST
Ø3.5 mm cortical screw - L 18 mm - sterile
1
SDT2.8L20-STI
Ø2.8 mm locking screw - L 20 mm- sterile
2
SOT3.5L20-ST
Ø3.5 mm locking screw - L 20 mm - sterile
2
CT3.5L20-ST
Ø3.5 mm cortical screw - L 20 mm - sterile
2
SDT2.8L22-STI
Ø2.8 mm locking screw - L 22 mm - sterile
2
SOT3.5L22-ST
Ø3.5 mm locking screw - L 22 mm - sterile
2
CT3.5L22-ST
Ø3.5 mm cortical screw - L 22 mm - sterile
2
SDT2.8L24-STI
Ø2.8 mm locking screw - L 24 mm - sterile
1
SOT3.5L24-ST
Ø3.5 mm locking screw - L 24 mm - sterile
2
CT3.5L24-ST
Ø3.5 mm cortical screw - L 24 mm - sterile
2
Not anodized.
*
Anodized in dark blue.
Anodized in light blue.
*
*
Removal and rescue kits
Template
Sterile instruments
Sterile template
REMOVAL KITS
Ref.
Description
KIT-REMOVE-R
Removal kit for Ø2.8 mm screws
KIT-REMOVE-A
Removal kit for Ø3.5 mm screws
Ref.
Description
KIT-RESCUE-R
Rescue kit for Ø2.8 mm screws
KIT-RESCUE-A
Rescue kit for Ø3.5 mm screws
INITIAL A™ TEMPLATE
Ref.
Description
ANC607
Initial A template plate - Sizes 1/2/3 Right side and left side
Qty
5
RESCUE KITS
The information presented in this brochure is intended to demonstrate a NEWCLIP TECHNICS product. Always refer to the package insert, product label and/or user instructions before using any NEWCLIP TECHNICS product. Surgeons must always rely on their own clinical judgment when
deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your NEWCLIP TECHNICS representative if you have questions
about the availability of NEWCLIP TECHNICS products in your area.
Non contractual pictures.
NEWCLIP USA
642 Larkfield Center
Santa Rosa CA 95403, USA
Phone : + 1 707 230 5078
[email protected] - www.newclipusa.com
Brochure EN - Initial A - Ed.1 - 02/2015 -Medical devices: class IIb Read labeling and instructions before use.
0120 SGS UK - US Class: II
Example of kit content.
NEWCLIP TECHNICS
PA de la Lande Saint Martin - 45 rue des Garottières
44115 Haute-Goulaine - France
Tel : +33 (0)2 28 21 37 12 - Fax : +33 (0)2 40 63 68 37
[email protected] - www.newcliptechnics.com