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Index
Introduction
Surgical Technique
Set Detail
Sample Cases
IndicationsFeaturesImplants
2
4
15
22
223
15161718192021
Tray 1 (3.5 mm)Tray 2 (4.0 mm)Tray 3 (5.0 mm)Tray 4 (6.0 mm)Tray 5 (6.5 mm)Tray 6 (Instruments 1)Tray 7 (Instruments 2)
12° AngledDesign
Introduction
Indications
Features
Indicated for children older than 18 months who are diagnosed with osteogenesis imperfecta.
Children's long bone deformity corrections.
Fracture stabilization.
Prevention of bone fracture.
For patients with osteoporotic bone.
It is made of medical stainless steel.
Consists of 2 parts; D profile Bar (male nail) and suitable D profile tube (female nail) with threaded end.
The male, the female and the angled female nails have five different diameter choices. The male nail has one length choice for each diameter, which could be adjust to the desired length by cutting the nail. The female nails have 5 different length choices for each diameter and the angled female nails have 3 different length choices for each diameter.
During the growth of the child’s bone, the nails grow without any hindering due to the engagement (telescopic) of the male and female nails.
There is a special designed corkscrew end on the distal part of the male nail that holds the bone solidly and gives minimal damage to the growth plate.
Female nail’s cancellous proximal threads fix the nail to the bone. Proximal locking screw which is sent to the bottom of the cancellous threads of the female nail, avoids the female nail to move forward.
There is a female D profile nail with 12° Angled proximal part which is designed for tibia. The angled part has a gap (opening) on which the male nail can go through. Two slots and a hole, on which Kirschner wire can be used for fixation, are on the angled proximal part. The threads on the proximal part allow the fixation of the end cap and prevent the nail to exceed out of the bone.
The application of the nail for tibia and humerus is from the proximal part and for femur from proximal and distal part of the bones.
Special Angled Design For Tibia
2
Corkscrew
Femail Nail Thread
End CapMale Nail
Angled Female Nail
Implants
FEMALE NAILDIAMETER
FEMALE NAILLENGTH CHOICE
ANGLEDFEMALE NAIL
LENGTH CHOICEMALE NAIL THREAD
DIAMETER x LENGTH DIAMETER
110 mm120 mm130 mm140 mm150 mm
150 mm170 mm180 mm190 mm200 mm
150 mm200 mm210 mm230 mm250 mm
250 mm270 mm280 mm290 mm300 mm
190 mm200 mm250 mm280 mm300 mm
110 mm130 mm150 mm
150 mm180 mm200 mm
150 mm210 mm250 mm
150 mm210 mm250 mm
150 mm210 mm250 mm
3.5 mm
4.0 mm
5.0 mm
6.0 mm
6.5 mm
7.0 mm
7.5 mm
9.5 mm
10.0 mm
10.5 mm
END CAPDIAMETER
(Length 14 mm)
(Length 8 mm)
(Length 8 mm)
(Length 11 mm)
(Length 11 mm)
(Length 11 mm)
7.0 mm
7.5 mm
9.5 mm
10.0 mm
10.5 mm
2 x 180 mm
2.5 x 250 mm
3.5 x 300 mm
4 x 350 mm
5 x 350 mm
3
Surgical Technique
1.1 ANTEGRADE TECHNIQUE
A ENTRY POINT: From the tip of the trochanter major at the proximal femur, approximately 2 cm incision is performed.
B GUIDE WIRE INSERTION: From the tip of the trochanter major at the proximal femur a Guide Wire is advanced distally into the medullary canal.
4
osteotomy line
C OSTEOTOMY: The osteotomy is applied to the center of rotation and angulation (CORA) of deformity and then the Guide Wire is advanced distally.
D DISTAL GUIDE WIRE INSERTION: The Guide Wire is advanced to the distal segment until the epiphyseal line of the bone.
5
1.2 RETROGRADE TECHNIQUEGUIDE WIRE INSERTION: Procedure begins with osteotomy application to the center of deformity rotation and angulation (CORA). After the osteotomy the Guide Wire is inserted from the center point of the osteotomy line and advanced proximally. After fluoroscopic control the medullary canal is opened with an appropriate Reamer.
The Guide Wire is sent from the osteotomy line to the distal of the bone. The wire end must reach the distal epiphyseal line.
6
2 REAMERIZATIONReaming begins with the smallest Cannulated Reamer over the wire. Reaming process is done until the metaphysis.It should be avoid to perforate the epiphysis.
3 PLACEMENT OFTHE MALE NAIL
The male nail is advanced clockwise rotation through the distal segment with the T-Handle Male Nail Inserter.
7
Epiphysis
x
x
cm
cm
cutting level
4 CUTTING THE MALE NAILThe length of the outer part of the male nail and the level of trochanterica fossa are controlled by fluoroscopy. The distance between the tip of the male nail and the joint surface which was measured at the previous step are left and the exceeding part is cut.
The male nail is cut with the Special Rod Cutter according to the diameter of the nail.
8
5 PREPARATION OF THE FEMALE NAIL
The Driver and the Female Nail are fixed with a Wrench by holding the soft handle.
Appropriate size of the Female Nail is chosen and connected with Female Locking Telescopic Nail Driver. It is essential to place the D profile of driver and female nails D tube.
The wrench is turned clockwiseto tighten
9
x mm
x mm
The Female Nail is advanced into the proximal femur by sliding over the Male Nail.
Please pay attention to the laser marks while connecting male nail and female nail. They have to be at the same direction.
6 PLACEMENT OF THE TELESCOPIC NAIL
Soft Handle is rotated to send the nail until the proximal threads are completely embedded in the bone.
10
8 SLEEVE PLACEMENTAfter the incision, Protection Sleeve and Trocar are sent through the proper hole of the Guide Arm to pass the soft tissue.
7 GUIDE ARM CONNECTIONWhen the nail is in its final position, Guide Arm is mounted to the Female Locking Telescopic Nail Driver.
Mind the lasermarks to choose the appropriate hole for locking screw.
11
9 DRILLING AND DEPTH MEASURING
Trocar is removed and the Drill Sleeve is sent over the Protection Sleeve to help drilling. Drilling is made with 2.0 mm Drill.
10 PROXIMAL LOCKINGAfter detection of the length of the screw with the help of Depth Gauge, the screw is sent with 1.7 mm Hexagonal Tip.
The depth is measured with Depth Gauge to choose proper locking screw.
12
11 REMOVING THE GUIDE ARMAfter removing the Guide Arm, the Female Nail Driver is loosened with the Wrench by holding the Soft Handle and then separated.
12 DISTAL LOCKINGFixation to the distal epiphysis is increased by sending two Threaded Kirschner Wires into the corkscrew tip. The outer part is cut with the Wire Cutter then the rest of the wire is forwarded into the bone with a Pin Impactor.
The wrench is turned clockwiseto loosen
13
14
3 1510628 9 7114
Tray 1 (3.5 mm)
Set Details
code barcode description qty8680858424818868085842482586808584248328680858424849868085842485686808584087268680858408733868085840874086999310332298699931033328868085840006586808584001578680858425112868085840012686999310333738680858408887868085840889486999310109308680858420162
2222222242211111111
8071701103580717012035807170130358071701403580717015035805103501108051035013080510350150807112001808071000003502010000350040100000350875700003502010010035087500000350201003003502010003035020201030250801001
TELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø3.5X110 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø3.5X120 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø3.5X130 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø3.5X140 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø3.5X150 MMTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ3.5X110MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ3.5X130MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ3.5X150MTELESCOPIC INTRAMED. NAIL-MALE SS Ø2.0X180 MMTELESCOPIC I.M. NAIL END CAP SS 3.5 MMCANNULATED DRILL FOR Ø3.5 MM NAIL DRILL FOR END CAP Ø3.5 MMØ 3.5 MM FEMALE LOCKING TELESCOPIC NAIL DRIVER SCREW DRIVER QUICK TIP HEGZAGONAL Ø3.5x100 MMFEMALE NAIL DRIVER 3.5 MMØ 3.5 MM DRILL GUIDE (TELES)Ø 3.5 MM FEMALE NAIL TURNING TIPSCREW DRIVER QUICK TIP 2.5XØ5X130 MMTELESCOPIC NAIL DESIGN TRAY 1
1
2
3456789101112
15
3 1510628 9 7114
Tray 2 (4.0 mm)
code barcode description qty2222222242211111111
8680858424863868085842488786808584248948680858424900868085842492486808584087648680858408757868085840877186999310332368699931033335868085840007286808584001648699931033380868085842512986808584001338680858408900868085840891786808584241158680858420179
8071701504080717017040807170180408071701904080717020040805104001508051040018080510400200807112502508071000004002010000040040100000400875000004008757000040020100100400201004004002010003040016100200300801002
TELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø4.0X150 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø4.0X170 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø4.0X180 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø4.0X190 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø4.0X200 MMTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ4.0X150MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ4.0X180MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ4.0X200MTELESCOPIC INTRAMED. NAIL-MALE SS Ø2.5X250 MMTELESCOPIC I.M. NAIL END CAP SS 4.0 MMCANNULATED DRILL FOR Ø4.0 MM NAILDRILL FOR END CAP Ø4.0 MMFEMALE NAIL DRIVER 4.0 MMØ 4.0 MM FEMALE LOCKING TELESCOPIC NAIL DRIVERSCREW DRIVER QUICK TIP HEGZAGONAL Ø4.0x100 MMØ 4 MM DRILL GUIDE (TELES)Ø 4 MM FEMALE NAIL TURNING TIPSCREW DRIVER QUICK TIP Ø3X200 MMTELESCOPIC NAIL DESIGN TRAY 2
1
2
3456789101112
16
3 1510628 9 7114
Tray 3 (5.0 mm)
code barcode description qty222222224221111111
868085842487086808584249318680858424955868085842496286808584249798680858408788868085840879586808584088018699931033243869993103334286808584000898680858400171869993103339786808584251368680858400140868085840892486808584089318680858420186
TELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø5.0X150 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø5.0X200 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø5.0X210 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø5.0X230 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø5.0X250 MMTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ5.0X150MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ5.0X210MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ5.0X250MTELESCOPIC INTRAMED. NAIL-MALE SS Ø3.5X300 MMTELESCOPIC I.M. NAIL END CAP SS 5.0 MMCANNULATED DRILL FOR Ø5.0 MM NAIL DRILL FOR END CAP Ø5.0 MMFEMALE NAIL DRIVER 5.0 MMØ 5.0 MM FEMALE LOCKING TELESCOPIC NAIL DRIVER SCREW DRIVER QUICK TIP HEGZAGONAL Ø5.0x100 MMØ 5 MM DRILL GUIDE (TELES)Ø 5 MM FEMALE NAIL TURNING TIPTELESCOPIC NAIL DESIGN TRAY 3
80717015050807170200508071702105080717023050807170250508051050015080510500210805105002508071135030080710000050020100000500401000005008750000050087570000500201001005002010050050020100030500801003
1
2
34567891011
17
3 1510628 9 7114
Tray 4 (6.0 mm)
code barcode description qty222222224221111111
868085842498686808584250068680858425013868085842503786808584250448680858408818868085840882586808584088328699931033250869993103335986808584000968680858400188869993103340386808584251438680858400140868085840894886808584089558680858420193
TELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.0X250 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.0X270 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.0X280 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.0X290 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.0X300 MMTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ6.0X150MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ6.0X210MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ6.0X250MTELESCOPIC INTRAMED. NAIL-MALE SS Ø4.0X350 MMTELESCOPIC I.M. NAIL END CAP SS 6.0 MMCANNULATED DRILL FOR Ø6.0 MM NAILDRILL FOR END CAP Ø6.0 MMFEMALE NAIL DRIVER 6.0 MMØ 6.0 MM FEMALE LOCKING TELESCOPIC NAIL DRIVERSCREW DRIVER QUICK TIP HEGZAGONAL Ø5.0x100 MMØ 6 MM DRILL GUIDE (TELES)Ø 6 MM FEMALE NAIL TURNING TIPTELESCOPIC NAIL DESIGN TRAY 4
80717025060807170270608071702806080717029060807170300608051060015080510600210805106002508071140035080710000060020100000600401000006008750000060087570000600201001005002010060060020100030600801004
1
2
34567891011
18
3 1510628 9 7114
Tray 5 (6.5 mm)
code barcode description qty222222224221111111
868085842491786808584249488680858424993868085842502086808584250518680858408856868085840886386808584088498699931033267869993103336686808584001028680858400195869993103341086808584251508680858400140868085840896286808584089798680858408870
80717019065807170200658071702506580717028065807170300658051065015080510650210805106502508071150035080710000065020100000650401000006508750000065087570000650201001005002010060065020100030650801005
TELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.5X190 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.5X200 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.5X250 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.5X280 MMTELESCOPIC INTRAMED. FEMALE NAIL- LOCKING SS Ø6.5X300 MMTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ6.5X150MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ6.5X210MTELESCOPIC INTRAMED.ANGLED NAIL-FEMALE SSØ6.5X250MTELESCOPIC INTRAMED. NAIL-MALE SS Ø5.0X350 MMTELESCOPIC I.M. NAIL END CAP SS 6.5 MMCANNULATED DRILL FOR Ø6.5 MM NAILDRILL FOR END CAP Ø6.5 MMFEMALE NAIL DRIVER 6.5 MMØ 6.5 MM FEMALE LOCKING TELESCOPIC NAIL DRIVERSCREW DRIVER QUICK TIP HEGZAGONAL Ø5.0x100 MMØ 6.5 MM DRILL GUIDE (TELES)Ø 6.5 MM FEMALE NAIL TURNING TIPTELESCOPIC NAIL DESIGN TRAY 5
1
2
34567891011
19
12 15 1416 171318 19
Tray 6 (Instruments I)
code barcode description qty111111111
1213141516171819
868085840899386808584089868698673493506869993102377086999310238008699931023794869867349503686986734965078680858420216
SPECIAL ROD CUTTER FOR Ø 4.0,5.0 MMSPECIAL ROD CUTTER FOR Ø 2.0,2.5,3.5 MMPLATE WIRE CUTTER UP TO 3MMCHISEL HANDLECHISEL BLADE 16x30mm StraightCHISEL BLADE 11x30mm StraightLOCKING PLIERSRADIOGRAPHIC RULER 400 MMTELESCOPIC NAIL DESIGN TRAY 6
03210004050032102025350234502000003381000001033810160300338101103008201000004080500000110801006
20
2624 2830 25232921 20 27313522 363334 32
Tray 7 (Instruments II)
020101010020805100001208004000100080510000100366501000608051000011020000150170022204520608044000014087500090108027008071702701080717027012807170270148071702701680717027018807170270208071702702280717027024807170270268071702702880717027030807170270328071702703480717027036807170270388071702704001193003009045510061602341215001523410120150022710000030455100846023410450115234104501200331000000108050000200080100700543260180
869867349330886808584251678680858425174868085842509986808584274378680858425105868085842508286999310306178699931015737008750009010686808584274448680858426454868085842646186808584264788680858426485868085842649286808584265088680858426515868085842652286808584265398680858426546868085842655386808584265608680858426577868085842658486808584265918680858426607869993102813386999310297968698673452626869867345297886999310001398699931029796869867345793586986734579288680858400201868085840918186808584202238680858419265
SOFT SCREW DRIVER QUICK LARGETELESCOPIC NAIL GUIDE ARMTELESCOPIC NAIL DEPTH GAUGE FOR PROXIMAL SCREW TELESCOPIC NAIL SLEEVE FOR PROXIMAL SCREW TROCAR Ø6 x 100 MMTELESCOPIC NAIL DRILL GUIDE SCREW DRIVER QUICK HEX. TIP Ø 1.7X150 MM QUICK DRILL Ø 2X4.5X206 MMWRENCH Ø 13 MMPROTECTION SLEEVE (END CUP DRILL)TELESCOPIC NAIL SCREW BOXTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 10 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 12 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 14 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 16 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 18 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 20 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 22 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 24 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 26 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 28 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 30 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 32 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 34 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 36 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 38 MMTELESCOPIC NAIL LOCKING SCREW Ø2.7 x 40 MMBONE HAMMER SMALLK-WIRE TUBE Ø10XØ6X160 MMKIRSCHNER WIRE TREADED POINT 1.5X150 MMKIRSCHNER WIRE TROCAR POINT 1.5X120 MMPIN IMPACTOR K-WIRE TUBE Ø10XØ8X460 MMKIRSCHNER WIRE TROCAR POINT 1.5X450 MMKIRSCHNER WIRE TROCAR POINT 2X450 MMT-HANDLE JACOBS CHUCK-KEYT-HANDLE MALE NAIL INSERTERTELESCOPIC NAIL DESIGN TRAY 7KONTEYNER 543x260x180 MM
2111112221144444444444444441110212661112
code barcode description qty2021222324252627282930
3132
3334
3536
21
Sample Cases
Case 1
pre-op
post-op
22
Case 2
pre-op
post-op
follow-up
23
Case 3
pre-op
post-op
follow-up
24
Case 4
pre-op
post-op
follow-up
25
Warning: This description is not suf�icient by itself for direct and proper use of the instrument set intraoperatively.
Instruction by a surgeon who is thoroughly trained and experienced in handling these instruments and in doing the procedure are highly recommended.
pre-op post-op
follow-up
Case 5
TST
Med
ical
Dev
ices
rese
rves
the
right
to u
pdat
e, ch
ange
or m
odify
cont
ents
and
pro
duct
s at a
ny ti
me
with
out a
ny n
otic
e or
liab
ility
.
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REV0
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.01.
2017