Biomet Vision Pin-To-Bar Fixation System Surgical Technique...Additional indications for the Biomet® Vision FootRing System, a sub system of the DynaFix Vision External Fixation System

Surgical Technique

Biomet® Vision™

Pin-To-Bar Fixation System

B

Contents

Introduction .................................................... Page 1

Indications and Contraindications ................... Page 2

Basic Principles

And Biomechanical Concepts .......................Page 3

Instruments .................................................... Page 6

System Tray ................................................... Page 9

Bone Screw Insertion Technique ..................... Page 10

Surgical Technique ......................................... Page 14

Ordering Information ....................................... Page 22

Sterilization ..................................................... Page 27

Further Information ......................................... Page 28

1

Introduction

The Biomet Vision Pin-To-Bar Fixation System allows

independent pin placement. With this system, simple and

effective external fixation can be applied. The Biomet Vision

System is versatile enough to be used as both temporary and

definitive fixation. Temporizing measures include spanning

transarticular fixation or non-spanning fixation for severe soft

tissue damage or contamination. Definitive fixation uses include

unilateral single bone fixation, hybrid configuration and even

use in hinge designs at the elbow and knee. It can also be

applied to open book pelvic injuries as a resuscitive frame

or a definitive fixator.

The simplicity and ease of use make this fixator friendly in

the operating room for quick applications. For delayed open

reconstruction in periarticular fractures, the Biomet Vision

Pin-To-Bar Fixation System functions as an excellent means of

“portable traction”. This allows the patients the benefit of soft

tissue healing while having the option of being at home and

waiting for their elective procedures. It allows the surgeon the

benefits of getting the patient out of the hospital quickly and

readmitting for a well-planned surgery or for transfer to the

appropriate physician.

Spanning fixator placement can easily be converted to a hybrid

configuration by simply adding a ring with tensioned wires to the

articular fragment. This assembly then connects to the previously

placed pins and rods. Adaptation to the hybrid or ankle frame

can also be preformed with the included components.

NOTE: Picture shown is for demonstration purposes only.

This example would require perfect reduction.

Indication and Contraindications

2

INDICATIONS

The DynaFix Vision Unilateral System and the DynaFix Vision

External Fixation System are external fixation device intended

for use in the treatment of bone conditions including leg

lengthening, osteotomies, arthrodesis, fracture fixation, and

other bone conditions amenable to treatment by use of the

external fixation modality.

Additional indications for the Biomet® Vision FootRing System,

a sub system of the DynaFix Vision External Fixation System

include:

• Correction of deformity

• Revision procedures where other treatments

or devices have been unsuccessful

• Bone reconstruction procedures

• Fusions and replantations of the foot

• Charcot reconstruction and Lisfranc dislocations

• Ankle distraction (arthrodiastasis)

CONTRAINDICATIONS

Patients with mental or neurologic conditions who are unwilling

or incapable of following postoperative care instructions.

DFS® Bone Screws

5 Hole Clamp(P/N 03122)

3 Hole Clamp(P/N 03121)

3

Component And Instrument Review

SLM Rapid Rod-To-Rod Clamp

Catalog # Description

14600 SLM Rapid Rod-To-Rod Clamp

The SLM Rapid Rod-To-Rod Clamp has a serrated locking mechanism, which can be tightened from either side of the clamp with a 5.0 mm Allen Wrench. (Please note the directional arrow for locking etched on the clamp surface) The clamp was designed for rapid application and secure attachment to the Biomet Vision Rods. The key feature of the SLM Rapid Rod-To-Rod Clamp is the ability to secure the clamp from both sides in a single step locking procedure. These clamps are MRI safe.

SLM Rapid 4.0mm-6.0 mm Screw-To-Rod Clamp


14-400070 SLM Rapid 4.0 mm-6.0 mm Screw Clamp

The SLM Screw-To-Rod Clamp was designed for ease of use and rapid locking. A single step serrated lock allows for speed of application and secure purchase on rods, 4.0 mm, 5.0 mm, 6.0 mm bone screws and 4.0 mm, 5.0 mm, 6.0 mm Transfixing Screw. This clamp is locked with a 5.0 mm Allen Wrench (PN 03110). The key feature of the SLM Screw-To-Rod Clamp is the ability to snap on to both the rod and the shank of 4.0 mm, 5.0 mm, 6.0 mm screws and Transfixing Screws. This clamp also has the ability to lock to the shank of 4.0 mm, 5.0 mm, 6.0 mm diameter screws. These clamps are MRI safe.

Biomet Vision Clamps


14060 3-Hole Clamp

14090 5-Hole Clamp

The 3 and 5-Hole Clamps were designed for multi-pin fixation, which increases frame stiffness. The Clamp Cover Bolts are locked down with the 5.0 mm Allen Wrench to secure Bone Screws within the clamp. The 2 Clamp 3/5 Post can be attached to both sides of the clamp for Rod or Bone Screw attachment. The 2 Clamp 3/5 Post is secured to the 3 or 5-Hole Clamps with the Ratcheting T-Handle (P/N 03121 and P/N 03122).

NOTE: These clamps are not recommended for spanning fixators.

2 Clamp 3/5 Post


14-400065 2 Clamp 3/5 Post

The 2 Clamp 3/5 Post is utilized with the 3-Hole and 5-Hole Clamps primarily for Rod attachment, but can also be used for Bone Screw Clamp attachment. The 2 Clamp 3/5 Post is secured to either the 3-Hole Clamp or the 5-Hole Clamp with a 5.0 mm Allen Wrench or 9.0 mm Wrench.

Basic Principles And Biomechanical Concepts

Half-Pin Frame Biomechanics

The ideal frame stiffness is unknown. To increase frame stability, the following principles should be followed:

1. Use the largest diameter pin possible without the pin being larger than 1/3 the diameter of the bone.

2. Maximize pin spread within each fracture fragment.

3. Place the Rod as close to the skin as possible, making sure to leave enough room for additional soft tissue swelling.

4. Placing pins out of plane will add stiffness in additional planes.

5. Place a second Rod on the frame (double stacked).

6. For osteopenic bone increase the number of pins in the construct.

7. Maximize the pin spread within a fixed 5-Hole Clamp or 3-Hole Clamp.

Component And Instrument Review (Continued)

4

Transfixing Screws


14280 4.0 mm Screw

14186 5.0 mm Screw

14285 6.0 mm Screw

The 4.0 mm, 5.0 mm and 6.0 mm Transfixing Screws were

designed primarily for temporizing fixation techniques which

typically span a joint and zone of injury. The Transfixing

Screws are secured to the frame with either style Rapid Bone

Screw Clamp. All sizes of Transfixing Screws are equipped

with a drilling tip and centrally threaded body. The 6.0 mm

Transfixing Screw is unique in that it has a removable drill tip.

It is important to note that the 6.0 mm Transfixing Screw

should not be reversed while the removable drill tip is

attached or it may become detached while in bone or

soft tissue!

TIP: The removal of the 6.0 mm drill tip may be accomplished

by using two T-Handle Screw Inserters at each end.

Bent U-Bars


21280 Bent U-Bar (190 mm Inner Dia.)



The Bent U-Bars are used primarily for periarticular fracture

fixation with bone screws. The bars have an angled step off

to allow for enhanced radiographic visualization and surgical

access. Please note that these bars were not designed for

small tensioned wire fixation and only Screw Clamps or

Rod-To-Rod Clamps should be utilized with the Bent U-Bars.

NOTE: 6.0 mm Transfixing Screw cannot be used

with Triple Stack.

5

Biomet Vision Rods

Aluminum


14130 150 mm x 9.5 mm (Dia.)

14135 200 mm x 9.5 mm (Dia.)

14140 250 mm x 9.5 mm (Dia.)

14145 300 mm x 9.5 mm (Dia.)

14150 350 mm x 9.5 mm (Dia.)

14155 400 mm x 9.5 mm (Dia.)

Carbon


14160 150 mm x 9.5 mm (Dia.)

14165 200 mm x 9.5 mm (Dia.)

14170 250 mm x 9.5 mm (Dia.)

14175 300 mm x 9.5 mm (Dia.)

14180 350 mm x 9.5 mm (Dia.)

14185 400 mm x 9.5 mm (Dia.)

14650 500 mm x 9.5 mm (Dia.)

14660 600 mm x 9.5 mm (Dia.)

The Biomet Vision Rods are available in aluminum and carbon.

These materials vary in stiffness with carbon being the stiffer

of the two and can be utilized to make a construct more or less

rigid. These Rods are offered in a 9.5 mm diameter, and are

available in a variety of lengths. Carbon fiber Rods have the added

benefit of being radiolucent and extremely lightweight.

Triple Stack

The Triple Stack (TS) trocar should not be used to protect soft

tissue during drilling and screw insertion.

The TS is designed to help minimize soft tissue damage while

adding to the effectiveness of screw insertion. The TS contains

a friction fit between the soft tissue and the drill sleeve. The TS

allows the two components to remain engaged after the trocar

has been used to dimple the bone and then been removed. Once

the trocar is withdrawn, the bone can be drilled and the drill

guide can be withdrawn. This will allow the screw to be inserted

through the soft tissue into the bone. The serrated teeth on the

soft tissue sleeve will maintain its position to the drill hole.

The TS can be used free hand or through the Biomet Vision

3 or 5 Hole Clamp.

The Triple Stack will provide:

1. Minimal soft tissue damage.

2. Simple dimpling of the bone.

3. Retention of the drill hole site after removal of the drill sleeve.

Instruments

6

TS 4.8 mm Drill SleevesP/N: 14-400034 (60 mm) 14-400036 (100 mm) 14-400037 (125 mm)

TS 3.2 mm Drill SleevesP/N: 14-400030 (60 mm) 14-400032 (100 mm)

C/D WrenchP/N: 21420

5.0 mm Allen WrenchesP/N: 03110 (Top Image) 03111 Low Profile (Bottom Image)

C/D Strut (30mm)P/N: 21252

5.0 mm Hex Square Shaft, ShortP/N: 03122

TS Soft Tissue SleevesP/N: 14-400020 (60 mm) 14-400025 (100 mm) 14-400027 (125 mm)

5.0 mm Quick WrenchP/N: 14630

Bone Screw DriversP/N: 14-400055 (4.0 mm) 14-400050 (6.0 mm)

7

TS Trocars (For 3.2 mm Drill Sleeves)P/N: 14-400040 (60 mm) 14-400042 (100 mm)

TS Trocars (For 4.8 mm Drill Sleeves)P/N: 14-400044 (60 mm) 14-400046 (100 mm) 14-400047 (125 mm)

Bone Screw Inserter (Square Drive)P/N: 14-400060

Biomet Vision Pin-To-Bar Fixation System Tray (Empty)P/N: 14-400075

5.0 mm Hex Shaft, LongP/N: 14-400062

Instruments (Continued)

8

Drill Bits P/N: 03036 (3.2 mm x 240 mm) 03015 (4.8 mm x 240 mm)

Tip designed to stabilize drill bit on bone to prevent ‘wandering’.

DFS Bone Screws (Assorted Diameters/Lengths)

Disposables

9

System Tray

Lower Tier

Middle Tier

Upper Tier

Complete System Tray - P/N: 14-400076

Pin Caddy

Bone Screw Insertion Technique

10

1. Pre-operative planning is recommended prior to application

of this device. Access potential screw site location based on

fracture pattern, involved bone and associated safe soft tissue

corridor.1 Prep and drape in routine sterile fashion.

2. Obtaining a preliminary reduction of the fracture site

may make bone screw location easier to identify, but is not

necessary for pin insertion. The first bone screw is generally

inserted in to the shortest or most difficult fragment. When

possible, allow 2-1/2 cm of distance between fracture site

and first bone screw.

3. A 1.0-1.5 cm incision is made and blunt dissection

to the bone.

4. A “triple-stack” consisting of an appropriate size/length

trocar, soft tissue guide and drill guide is then utilized to

identify the center of the bone and establish the correct

orientation of the screw tract to be pre-drilled.

The orientation of the insertion of the bone screw should

usually be perpendicular to the axis of the bone to maximize

biomechanical stability. (Figure 1).

1 Behren, F. And Searls, K.: JBJS (Br) 68: 246-254, 1986.

Figure 1

11

5. Once the screw site is selected use gentle pressure to maintain

contact between the soft tissue guide and the cortex of the bone.

Extract the Trocar. (Figure 2).

6.0 mm Screw Shank Diameter

Drill Guide/Drill Bit Screw

4.8 mm 6.0 mm/5.0 mm Cortical

3.2 mm 6.0 mm/5.0 mm Cancellous



4.0 mm Screw Shank Diameter

Drill Guide/Drill Bit Screw

2.7mm 3.3 mm/3.0 mm Cortical

2.0mm 3.0 mm/2.5 mm Cortical

NOTE: Bone screw diameter should not exceed 1/3 diameter

of the bone.

6. Insert matching drill bit into drill guide. Drill both cortexes.

(Figure 3).

NOTES:

1. Once you have inserted a tapered bone screw

you will lose purchase if you back it out.

2. Self-drilling, self-tapping screws are available

for those who wish to use them.

Figure 2

Figure 3

Bone Screw Insertion Technique (Continued)

12

7. Drilling should be done bicortically with care not to penetrate

into underlying soft tissue. (Figure 4).

8. After bicortical penetration of the drill bit, the drill bit

and drill guide are withdrawn. (Figure 5 and 6).

Maintain contact and position of the soft tissue.

Figure 4

Figure 5

Figure 6

13

9. The appropriate length screw is then inserted through

the soft tissue sleeve. (Figure 7). The bone screw T-Wrench

is used to advance the screw into the bone (Figure 8). To

obtain optimal purchase, all bone screws must be bicortical

with no less than 2.0 mm protruding from the far cortex and

about 5.0 mm remaining outside the near cortex. Remove Soft

Tissue Sleeve. (Figure 9). Since screw is tapered, far cortex

cannot be accurately judged by feel, therefore image

intensification is utilized to confirm depth of penetration.

Figure 7

Figure 8

Figure 9

Surgical Technique*

14

Pelvis Fractures

• Unstable pelvic ring injuries

• “Open-book” pelvic fractures

• Highly contaminated wounds

• Patients who cannot physiologically tolerate an extended surgical procedure

• Supplementing posterior fixation

Anterior Superior Iliac Spine (ASIS)

Two pins are applied to either iliac crest and connected with

an anterior frame.

The Anterior Superior Iliac Spine (ASIS) is identified and the

insertion points are 2.0 cm posterior for the first pin. The second pin

is inserted approximately 2.0-3.0 cm posterior to the first along

the crest. A small incision is centered over the iliac crest/tubercle

and sharply dissected down to bone. The medial and lateral bit

borders of the crest are identified. The 4.8 mm drill bit and drill

guide are then used to drill the cortex in the middle to a depth of

approximately 1.0 cm. The 6.0 mm pin is then inserted through

the soft tissue sleeve. Care must be taken to ensure that the pin

does not penetrate the inner or outer table of the crest.

The second pin is inserted in a similar fashion. Screw clamps are

used to connect the two half-pins on either side. The frame is

trapezoidal in shape and fixed such that the patient can sit up in

bed. Surgeons are encouraged to achieve reduction by applying

a compressive force across the pelvic ring by pushing against the

greater trochanter. It is not recommended to push against the screw

clamps. This will increase forces on the pin to bone interface. This

can also increase or exacerbate posterior instability. Pushing from

the greater trochanter will provide an even compressive force across

the pelvic ring. Once adequate compression has been achieved, all

locking components should be definitively tightened. Traction is

applied as may be necessary.

Biomet Vision Pelvis Iliac Crest (Anterior View)

* 5.0 mm Quick Wrenches (P/N 14630) can be used for provisional

hand-tightening of the bone screw clamps. Reduction and final

tightening can be achieved using the 5.0 mm Allen Wrenches.

15

Anterior Inferior Iliac Spine (AIIS)

AIIS is identified as single pin fixation for quick pelvic

stabilization. One pin is inserted into each anterior inferior

iliac spine (AIIS).

These obviously, are deeper pins, and an image intensifier

is required. A pin size of at least 200 mm is recommended.

Pin insertion technique should follow standard protocol for

manual pin insertion. Care must be taken to avoid the hip joint.

Supra-acetabular pin placement, less familiar to most surgeons

than iliac wing pin placement is, can provide a more reliable

pin-bone interface and thus allow improved reduction ability

with fewer soft-tissue complications. Because of their location,

supra-acetabular pins also seem to be better tolerated than iliac

crest pins when used for definitive management of the pelvic

ring disruption.

Anterior Inferior Iliac Spine (Anterior View)

Anterior Inferior Iliac Spine (Lateral View)

Surgical Technique (Continued)

16

Midshaft Femur Fracture

• Pediatric femur fractures

• Vascular injury with prolonged ischemia time

• Severe soft tissue compromise

Half-pins are usually inserted from the lateral side of the femur.

Ideally pins should be placed obliquely along the lateral intra-

muscular septum so that the pin transfixes the least amount of

muscle. For extremely unstable fractures a frame may be double

stacked to increase stiffness and rigidity. A minimum of two pins

are placed distal and proximal to the fracture. Using traction and

manipulation, the fracture is reduced and the clamps tightened.

The pins are connected to a 9.5 mm carbon rod with the

4.0mm-6.0 mm pin to rod clamps and definitively tightened.

Independent Pin Placement For Femoral Shaft Fractures

(Adjustments And Fine-Tuning Can Be Made Using

This Technique)

Alternatively, the pin can be placed freehand in each fragment

using a short 9.5 mm carbon rod and two 4.0mm-6.0 mm pin

clamps. A Rod-to-Rod Clamp is then used to connect the two

shorter bars together. The fracture is reduced using manual

traction and manipulation. Then all clamps are tightened.

This frame is typically double stacked to increase frame stability.

NOTE: Picture shown is for demonstration purposes only.

This example would require perfect reduction.

Midshaft Femur Single Stack (Anterior View)

17

Tibia Fractures, Midshaft Fractures

• Vascular injury


• Patients who cannot physiologically tolerate an extended surgical procedure

• Highly contaminated wound

Independent Pin Placement – Single Stacked

Tibial Fixation

Tibial pins are usually placed either in an anteromedial

direction starting on the anteromedial face of the tibia or in an

anteroposterior direction starting just medial to the tibial crest.

A minimum of two pins are placed freehand in each fracture

fragment and connected to a Rod using 4.0mm-6.0 mm Pin-to-

Rod Clamps. The two Rods are then connected using a Rod-to-

Rod Clamp. A reduction is performed using manual traction and

all clamps are definitively tightened.


18

Independent Pin Placement – Double Stacked

Tibial Fixation

Tibial pins are usually placed either in an anteromedial

direction starting on the anteromedial face of the tibia or in an

anteroposterior direction starting just medial to the tibial crest.

The two Rods are then connected using a Rod-to-Rod Clamp.

A reduction is performed using manual traction and all clamps

are definitively tightened. To increase the stiffness of the frame

a second rod can be used.

The fracture should be preliminarily reduced, then the most distal

and proximal pins are placed in a colinear fashion. Reduction is

then reassessed and clamps tightened.

Finally, the two pins closest to the fracture are placed

through pin clamps to ensure correct positioning and

to maintain reduction. The clamps are then tightened.

Midshaft Tibia Single Stack (Medial View)

Midshaft Tibia Double Stack (Anterior View)

19

Elbow Spanning Frame

• Open fractures


• Patients who cannot physiologically tolerate internal fixation

• Highly contaminated wounds

The humeral pins are placed from lateral side of the arm while

when in the distal humerus pins can be place either from the

lateral side or posteriorly. Because of potential damage to

radial nerve the pins must be placed using open incisions

with the bone visualized and using guides to protect the

neurovascular structures.

Ulna pins can be placed percutaneously through the subcutaneous

border of the ulna. A simple single stacked frame is usually

sufficient for the elbow. A reduction is performed using manual

traction and all clamps are definitively tightened. Pin-To-Bar

Clamps are attached to all the pins and then two carbon fiber rods

are attached and tightened. If a third rod is needed to make a

connection between these two rods, it can be used.

Elbow Spanning Frame (Lateral View)


20

Knee Spanning Anterior Frame

(For Temporizing Fixation)

• Complex open distal femur fractures not amenable to acute fixation

• Unstable knee dislocation

• Complex tibial plateau fractures with soft tissue compromise

• Distal femur and proximal tibial fractures with instability

The most important concept to keep in mind when placing

a knee spanning frame is to try to keep pins away from the

zone of injury whenever possible. In addition, pins should

be kept away from the future sites of internal fixation. While

this may sacrifice stability by not having pins close to the

fracture site it will minimize potential complications. Another

key concept is to make sure no pin is placed intra-articular

within the knee joint. If a large flash of blood is returned

when placing the triple sleeve, this typically indicates you

are in the supra patellar pouch and the pin should not be

placed in this location but moved more proximal.

When spanning the knee for a distal femur fracture the frame is

mounted on the proximal femur and proximal tibia while when

treating the proximal tibia the frame is mounted on the distal

femur and distal tibia. By following these general rules the

concepts discussed above can be maintained.

The femoral pin insertion sites are identified as proximal to all

fractures and all future internal fixations. Pins are inserted in

the anterior or anterior lateral surface of the femur using triple

stacked trocar and sleeve as stated previously, then using the

independent pin placement technique for pin to bar clamps.

Spanning Knee (Medial View)

Spanning Knee (Anterior View)

The next pins will be placed in the tibia away from the fracture

and all future internal fixation sites, using the same technique

as for the proximal femur. Anterior or anteromedial placement

is used. A pin to bar clamp is then applied to each pin, keeping

clearance for soft tissue maintenance.

Once the pin clamps are in place, two 9.5 mm carbon bars are

placed into the clamps one proximal and one distal that will

extend pass the knee joint. Where the two carbon rods meet at

or near the knee joint a bar to bar clamp is used to attach them

together. If the rod do not meet close enough together then a

smaller 9.5 mm carbon rod with two bar to bar clamps may be

used to attach all rods together.

Using traction and manipulation, the fracture may be reduced

and all the clamps tightened definitively. Care should be taken

to keep the knee joint flexed approximately 15° to relax the

posterior neurovascular if needed. To make this a definitive

frame all that is needed to double stack the frame.

21

Ankle Spanning Frame With Transfixing Screw

(For Temporizing Fixation)

• Distal tibia fracture

• Plafond fracture with or without fibula fixation

• Unstable ankle fracture or dislocations


Tibial pin site should be planned in accordance with secondary

or definitive protocols in mind. Pins are inserted into the

anteromedial or anterior surface of the tibia, using triple stacked

trocar and sleeve as stated previously. Two pins are placed

independently while staying out of the zone of injury and work

area. A pin to bar clamp may be attached to each pin in the tibia

at this time. A 4.0 mm, 5.0 mm, or 6.0 mm transfixing screw may

be used in the calcaneous. (When using the 6.0 mm transfixing

screw do not use the soft tissue sleeve the screw threads are

7.0 mm the sleeve is for a 6.0 mm screw) A small incision is

made posterior and distal to the neurovascular bundle, and blunt

dissection is made down to the bone. Following pin insertion

protocol the calcaneal transfixing screw is inserted in to the bone

parallel to the ankle joint. A pin to bar clamp is now attached to

medial and the lateral side of the transfixing screw. A 9.5 mm

appropriate length carbon rod, is now attached from one side of

the transfixing screw to the proximal screw in the tibia.

The next 9.5 mm rod is connected to the inferior pin in the tibia

and other side of the transfixing screw. Apply traction to the tibia

along its long axis, using the calcaneal transfixing screw. Once

adequate reduction is achieved, tighten all clamps. All clamps

should be checked for definitive locking.

NOTE: A smaller screw may be placed in the base of the first

metatarsal, and attached to a supplemental pin to bar clamp

and rod then attached to the existing frame to help keep the foot

out of eqinnus.

Spanning Ankle Transfixing Screw Frame (Anterior View)

Ordering Information

22

UPPER Tier

Catalog # Description Set Qty.

03015 4.8 mm x 240 mm Long Drill Bit (A/O) 2

03036 3.2 mm x 240 mm Long Drill Bit (A/O) 2

14280 Transfixing Screw 4.0 mm x 350 mm 2



14-400020 TS Soft Tissue Sleeve (60mm) 2

14-400025 TS Soft Tissue Sleeve (100mm) 2

14-400027* TS Soft Tissue Sleeve (125mm) N/A

14-400030 TS 3.2 mm Drill Sleeve (60mm) 2




14-400037* TS 4.8 mm Drill Sleeve (125mm) N/A

14-400040 TS Trocar For 3.2 mm Drill (60mm) 2




14-400047* TS Trocar For 4.8 mm Drill (125mm) N/A

Sterilization Tray

Catalog # Description Qty.

14-400075 Vision Pin-To-Bar Tray (Empty) 1

Optional Components And Instruments

(Not Included In Set)

Catalog # Description Qty.*

14055 Telescoping Bone Screw Post 1

14330 Ring Connector Assembly 1

14350 50 mm Connector Rod 1



14080 Double Rod Connector 1

14245 Vision 9.0 mm Wrench 1

14270 Vision 5.0mm/13 mm L-Wrench 1

14290 Vision L-Bar 1

* Optional In #14-400076 Not Packed In Set

System Tray (Complete)


14-400076 Vision Pin-To-Bar Fixation System Tray 1 (Consists Of Lower, Middle & Upper Tier)

LOWER Tier


14160 Carbon Fiber Rod, 9.5 mm Dia. x 150mm 4







14660* Carbon Fiber Rod, 9.5 mm Dia. x 600mm N/A

14600 SLM Rapid Rod-To-Rod Clamp 12

14060 3-Hole Clamp 2

14090 5-Hole Clamp 2

14-400065 2 Clamp 3/5 Post 4

14-400070 SLM Rapid 4.0mm-6.0mm 20 Pin-To-Rod Clamp

MIDDLE Tier


03110 5.0 mm Allen Wrench 2

03111 5.0 mm Allen Wrench (Low Profile) 2

03121 Ratcheting T-Handle (Square Drive) 2

03122 5.0 mm Hex Shaft Square Shaft 2

14245 9.0 mm Wrench 2

14630 5.0 mm Quick Wrench 2

21252 C/D Strut (30mm) 4

21280 Bent U-Bar (190mm) 2

21285 Bent U-Bar (220mm) 2

21290 Bent U-Bar (250mm) 2

21420 C/D Wrench 2

14-400050 6.0 mm Bone Screw Driver 2

14-400055 4.0 mm Bone Screw Driver 2

14-400060 5.0 mm Ball Hex Shaft (Square Drive) 2

14-400062 5.0 mm Ball Hex Shaft Long (Square Drive) 2

23

DFS Bone Screws

6.0mm/5.0 mm Tapered Cortical Bone Screws

w/6.0 mm Shank – Drill Size: 4.8mm

Catalog # Thread Type/Thread Length

A60-09030 Cortical-90/30

A60-09040 Cortical-90/40

A60-10030 Cortical-100/30

A60-10040 Cortical-100/40

A60-11030 Cortical-110/30

A60-11040 Cortical-110/40

A60-11050 Cortical-110/50

A60-12040 Cortical-120/40

A60-13030 Cortical-130/30

A60-13040 Cortical-130/40

A60-13050 Cortical-130/50

A60-13060 Cortical-130/60

A60-13070 Cortical-130/70

A60-14080 Cortical-140/80

A60-14090 Cortical-140/90

A60-15030 Cortical-150/30

A60-15040 Cortical-150/40

A60-15040T Cortical-150/40

A60-15050 Cortical-150/50

A60-15050T Cortical-150/50

A60-15060 Cortical-150/60

A60-16030 Cortical-160/30

A60-16040 Cortical-160/40

A60-16050 Cortical-160/50

A60-17040 Cortical-170/40

A60-17060 Cortical-170/60

A60-18030 Cortical-180/30

A60-18040 Cortical-180/40

A60-18050 Cortical-180/50

A60-18060 Cortical-180/60

A60-20050 Cortical-200/50

A60-20060 Cortical-200/60


w/6.0 mm Shank – Drill Size: 4.8 mm (Continued)


A60-22030T Cortical-220/30

A60-22040T Cortical-220/40

A60-22050 Cortical-220/50

A60-22050T Cortical-220/50

A60-22060 Cortical-220/60

A60-22060T Cortical-220/60

A60-25030T Cortical-250/30

A60-25040T Cortical-250/40

A60-25050T Cortical-250/50

A60-25060T Cortical-250/60

A60-25080T Cortical-250/80

A60-25010T Cortical-250/100

A60-30060 Cortical-300/60




A45-06020 Cortical-60/20

A45-07020 Cortical-70/20

A45-08020 Cortical-80/20

A45-08030 Cortical-80/30

A45-08040 Cortical-80/40

A45-10020 Cortical-100/20

A45-10040 Cortical-100/40

A45-12020 Cortical-120/20

A45-12040 Cortical-120/40

Catalog numbers ending in “T” are Trocar tipped (self-drilling) screws. All

bone screws are tapered.

Ordering Information (Continued)

24

6.0mm/5.0 mm Tapered Cancellous Bone Screws w/6.0 mm

Shank – Drill Size: 3.2mm


B60-09030 Cancellous-90/30
















B60-18010 Cancellous-180/100






A35-06020 Cortical-60/20

A35-07020 Cortical-70/20

A35-08030 Cortical-80/30

A35-09040 Cortical-90/40




A33-07015 Cortical-70/15

A33-07020 Cortical-70/20

A33-08020 Cortical-80/20

A33-08035 Cortical-80/35


w/4.0 mm Shank Trocar Tipped – Drill Size: 2.7mm


A33-07020T Cortical-70/20






A30-07020 Cortical-70/20

A30-09040 Cortical-90/40








25






Threaded Wires (Package Of 4)


M16-07015 Self-Drilling-70/15

M16-10015 Self-Drilling-100/15

DFS Bone Screws Surgical Trays


03170 Cortical 6/5 Bone Screw Surgical Tray

03180 Cancellous 6/5 And Aux. Cortical Bone Screw Tray

03165 Bone Screw Surgical Tray

6.0mm/5.0 mm Tapered Hydroxyapatite Cortical Bone

Screws w/6.0 mm Shank – Drill Size: 4.8mm


HAA60-10030 Cortical-100/30
















6.0mm/5.0 mm Tapered Hydroxyapatite Cortical Bone

Screws w/6.0 mm Shank – Drill Size: 4.8 mm (Continued)
















6.0mm/5.0 mm Tapered Hydroxyapatite

Cancellous Bone – Drill Size: 3.2mm


HAB60-10030 Cancellous-100/30
















Ordering Information (Continued)

26




M30-05018T Cortical-50/18











Self-Drilling, Self Tapping Bone Screws

w/6.0 mm Shank – Drill Size 4.8mm


SD60-15050 Cortical-150/50

SD60-18060 Cortical-180/60

SD60-20070 Cortical-200/70

SD60-25080 Cortical-250/80



SD50-12030 Cortical-120/30

SD50-15050 Cortical-150/50

SD50-18050 Cortical-180/50

SD50-20080 Cortical-200/80

SD50-25050 Cortical-250/50

SD50-25080 Cortical-250/80

w/4.0 mm Shank – Drill Size 3.2mm


SD40-08020 Cortical-80/20

SD40-10030 Cortical-100/30

SD40-12040 Cortical-120/40

SD40-14040 Cortical-140/40







27

Sterilization

The DynaFix Vision Unilateral System and the DynaFix Vision

External Fixation System are provided non-sterile and must be

sterilized prior to use. All packaging materials must be removed

prior to sterilization. All fixator components should be sterilized in

a loosened state such that components may move freely.

The following steam sterilization parameters are recommended.

Cycle: Vacuum Steam

Temperature: 270°F/(132°C)

Time: 8 minutes

Drying time: 20 minutes

Repeated sterilization of carbon fiber reinforced epoxy is not

recommended.

Individuals or hospitals not using the recommended method,

temperature, and time are advised to validate any alternative

methods or cycles using an approved method or standard.

The Vision External Fixation System is a modular external fixator

intended for use in the treatment of bone conditions including leg

lengthening, osteotomies, arthrodesis, fracture fixation, and other

bone conditions amenable to treatment by use of the external

fixation modality.

Caution: Federal Law (USA) restricts this device to sale by or on

the order of a physician.

WARNING: This device is not approved for screw attachment

or fixation to the posterior elements

(pedicles) of the cervical, thoracic, or lumbar spine.

This brochure describes the surgical technique used by Attila

Poka, M.D. and Michael Sirkin, M.D. Biomet Trauma as the

manufacturer of this device, does not practice medicine and does

not recommend this product or any specific surgical technique

for use on any individual patient. The surgeon who performs any

implant procedure is responsible for determining the appropriate

products(s) and utilizing the appropriate technique(s) for said

implantation in each individual patient.

For further information, please contact the Customer Service

Department at:

Biomet Trauma

56 East Bell Drive

P.O. Box 587

Warsaw, Indiana 46581-0587

800.348.9500 x 1501

www.biomet.com

Further Information

28

©2013 Biomet Orthopedics • Form No. BMET0325.0 • REV011513

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.

This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.

Responsible ManufacturerBiomet, Inc. P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA

www.biomet.com

Rx only.

Documents

Biomet Vision Pin-To-Bar Fixation System Surgical Technique...Additional indications for the Biomet® Vision FootRing System, a sub system of the DynaFix Vision External Fixation System