BioDrive Micro Screw System - Zimmer Biomet · 1 Introduction Available in diameters of 2.0 mm, 2.3 mm and 3.0 mm, the BioDrive™ Micro Screw System offers a wide range of cannulated

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BioDrive™ Micro Screw System

©2013 Biomet Orthopedics • Form No. BMET0351.0 • REV013013

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.

Surgical Technique

BioDrive™ Micro Screw System

• Headless variable pitched compression screws specifically designed to stabilize small bone fragments around articular regions

B

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

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

Implant Specifications .................................... Page 3

BioDrive™ Micro Screw

Surgical Technique ......................................... Page 5

BioDrive™ Micro Nail Plate

Surgical Technique ......................................... Page 8

Tray Layout ..................................................... Page 12

Ordering Information ...................................... Page 14

Sterilization ..................................................... Page 16

Further Information......................................... Page 17

Contents

1

Introduction

Available in diameters of 2.0 mm, 2.3 mm and 3.0 mm,

the BioDrive™ Micro Screw System offers a wide range of

cannulated and non-cannulated headless compression screws

specifically designed to stabilize small bone fragments around

articular regions.

Longer pitched threads on the distal tip of the screw penetrate bone at a

faster rate than the shorter trailing threads, allowing interfragmentary

compression as the screw is advanced and countersunk.

Features:

• Headless design minimizes hardware prominence and soft tissue irritation

• Self-tapping screw threads minimize fracture site disruption during insertion

• Small diameter sizes (2.0 mm, 2.3 mm and 3.0 mm ) and smooth central shaft minimizes bone loss

during insertion

• Color-coded instrumentation facilitates intraoperative efficiencies

• Low profile Micro Nail Plate can provide interfragmentary compression and is well suited for areas of limited soft

tissue coverage

• Material: Titanium Alloy

• Self-drilling, self-tapping and self-countersinking

Micro Nail Plate with Fully Threaded 2.3 mm

Cannulated Screw

2.3 mm BioDrive™ Micro Screw (Cannulated)

2.0 mm BioDrive™ Micro Screw (Solid)


• 0.95 mm Plate Thickness

2

Indications and Contraindications

Indications

For Use For The BioDrive Micro Screw System

The Biomet® BioDrive Screw System is indicated for alignment

and stabilization of small bone fractures. Specifically:

1. Fixation of small bones, such as those in the foot, ankle,

wrist, elbow and hand for treatment of fractures, nonunions, or

malunions

2. Ligament reconstruction

3. Osteochondritis dissecans

4. Arthrodesis of the foot, ankle, wrist, elbow and hand

5. Small bone osteotomies, including first metatarsal head

osteotomy, metatarsal osteotomies, phalangeal osteotomies,

and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma,

deformity, osteoarthritis, and rheumatoid arthritis.

Contraindications

1. Active infection.

2. Patient conditions including blood supply limitations,

insufficient quantity or quality of bone.

3. Patients with mental or neurologic conditions who are

unwilling or incapable of following postoperative care

instructions.

4. Foreign body sensitivity. Where material sensitivity is

suspected, testing is to be completed prior to implantation of

the device.

3

Implant Specifications


Lengths: 10 mm -28 mm (2.0 mm increments)

Drill Bit Used: Catalog # FT230B

(1.6 mm Cannulated Drill Bit, Blue and Gray Ringed)

Screw Driver Used: Catalog # TV230B (Cannulated

1.5 mm Hex Screw Driver, Blue and Gray Ringed)

Countersink Used: Catalog # FR230B

(Cannulated Countersink, Blue Ringed)

Shaft Diameter: 1.6 mm

Proximal Thread Pitch: 0.8 mm

Distal Thread Pitch: 1.0 mm

Diameter: 2.3 mm

Diameter: 3.4 mm




Diameter: 2.0 mm

Diameter: 3.4 mm

2.0 mm BioDrive™ Micro Screw (Solid)



(1.5 mm Solid Drill Bit, Gray Ringed)

Screw Driver Used: Catalog # TV200B

(Solid 1.5 mm Hex Screw Driver, Green Ringed)

4

Implant Specifications (Continued)

6.0 mm

Length:15 mm

5.9 mm 3.2 mm

0.95 mm

60°

BioDrive™ Micro Nail Plate and Screw

Screw Lengths: 11 mm -15 mm (1.0 mm increments)

Screw Diameter: 2.3 mm

Drill Bit Used for Screw: Catalog # FT230B

(Cannulated 1.6 mm Drill Bit, Blue and Gray Ringed)

Drill Bit Used for Nail Portion: Catalog # FT150B

(Solid 1.5 mm Drill Bit, Gray Ringed)

Screw Driver Used: Catalog # TV230B (Cannulated

1.5 mm Hex Screw Driver, Blue and Gray Ringed)




(1.9 mm Cannulated Drill Bit, Yellow Ringed)

Screw Driver Used: Catalog # TV300B

(2.0 mm Cannulated Hex Screw Driver, Yellow Ringed)

Countersink Used: Catalog # FR300B

(Cannulated Countersink, Yellow Ringed)




Diameter: 3.0 mm

Diameter: 4.7 mm

Micro Nail Plate with Inserter

(Catalog # A2300B)

5

Demonstrated with the 2.3 mm BioDrive™ Micro Screw

Step 1: Screw Site Preparation

After sufficient surgical exposure is obtained, perform the

appropriate osteotomy as indicated by procedure and surgeon

preference (Figure 1). Once bone segments are properly aligned,

K- wires can be inserted to temporary fixate the osteotomy and

mark the prescribed path of the screw (Figure 2).

Step 2: Guide Wire Placement

For each screw used, a 0.8 mm x 120 mm K-Wire (Catalog #

BR101DT) is inserted in the prescribed screw path.

NOTE 1: Guide wires should hit, but not perforate the far

cortex. When selecting the appropriate screw length, subtract

approximately 2.0 mm to account for osteotomy gap compression

as well as the desired amount of countersinking depth.

NOTE 2: Bone Reduction Forceps (Catalog # DA000B) and Small

Bone Holding Forceps (Catalog # 22894) are included in the set

and can be used to temporarily hold the osteotomy in place while

the screw site is prepared.

BioDrive™ Micro Screw Surgical Technique

Bone Reduction Forceps

(Catalog # DA000B)

Small Bone Holding

Forceps (Catalog # 22894)

Figure 1

Shown: Long Arm Chevron Osteotomy of the First Metatarsal

Figure 2

Shown: (Two) 0.8 mm x 120 mm K-Wires inserted

from distal-dorsal to proximal-planter

6

Step 3: Screw Sizing and Pre-drilling

When using the Wire Depth Gauge (Catalog # 14-400171),

slide the tapered end over the guide wire down to the bone.

The reading at the exposed end of the guide wire will indicate

the appropriate screw length (Figure 3).

NOTE 3: Although the BioDrive™ Micro Screws have cutting

flutes, it is recommended that screw paths are pre-drilled to

avoid the need for excessive insertion force.

NOTE 4: When using the screw measuring scale on the caddy,

the head of the screw must be held flush with the edge of the

caddy to ensure accuracy.

Using the color corresponding drill bit for the screw

being utilized, drill over the guide wire (Figure 4). The Depth

Gauge (Catalog # JA000B) can also be used to determine the

screw lengths up to 28 mm (Figure 5).

The set includes cannulated countersinks which can be utilized

to ensure that screw heads seat fully recessed (Figure 6).

(Available for 2.3 mm and 3.0 mm screws only)

BioDrive™ Micro Screw Surgical Technique (Continued)

Figure 5

Depth Gauge (Catalog # JA000B)

Figure 4

Figure 6

Figure 3

Wire Depth Gauge (Catalog # 14-400171)

7

Step 4: Screw Insertion

Using the Ergonomic Handle (Catalog # MV000B) and the color

corresponding screw driver, the screw is inserted over the

guide wire (Figure 7).

The varying thread pitches on the tip and head of the screw

will allow for interfragmentary compression as the screw is

passed and countersunk (Figure 8).

Confirm accurate screw placement and bone alignment before

addressing subsequent screws, which are prepared and

inserted in the same fashion.

Step 5: Wound Closure and Postoperative Care

After all screws are fully implanted, check final screw position

with image intensification. Guide wires are then removed

and capsular closure is performed. Excessive plication of the

capsule is not desirable.

The incision is then closed and the extremity is bandaged.

NOTE 5: In lower extremity procedures, it is advisable to place

patients in a postoperative shoe or boot during the return to

weight bearing.

Patients are encouraged to perform range of motion exercises

in the early postoperative period.

Figure 7

Figure 8

8

BioDrive™ Micro Nail Plate

Step 1: Osteotomy and Bone Realignment

After sufficient surgical exposure is obtained, perform the

appropriate osteotomy as indicated by procedure and surgeon

preference. Once bone segments are properly aligned,

pre-drilling can ensue.

Step 2: Micro Nail Plate Insertion Preparation

The Alignment Guide (Catalog # VA000B) is placed firmly

against the cortex (Figure 1). Pass the 1.5 mm Solid Drill Bit

(Gray Ringed, Catalog # FT150B) through the guide to create

the hole for the nail portion of the nail plate (Figure 2). Detach

the bit from the power drill and leave in place (Figure 3).

Micro Nail Alignment Guide (Catalog # VA000B)

BioDrive™ Micro Nail Plate Surgical Technique

Figure 1

Figure 2

Figure 3

9

After drilling the nail portion of the nail plate, insert a 0.8 mm

K-Wire through the wire hole of the Alignment Guide to the

desired depth (Figure 4).

The 1.5 mm Solid Drill Bit and the Alignment Guide are then

removed, leaving behind the guide wire (Figure 5).

The Wire Depth Gauge is then used to determine screw length.

The reading at the exposed end of the guide wire will indicate

the appropriate screw length.

Wire Depth Gauge (Catalog # 14-400171)

Drill over the guide wire to the appropriate depth using

the 1.6 mm Cannulated Drill (Blue and Grey Ringed,

Catalog # FT230B) (Figure 6).

Static Screw Site

NOTE 1: If compression is not desired, the static screw site on

the Alignment Guide can be utilized. This static screw site is

aligned with the center point of the nail plate’s screw hole.

Figure 4

Figure 6

Figure 5

10

Step 4: Micro Nail Plate Insertion

Attach the Nail Plate/Inserter (Catalog # A2300B) to the

Ergonomic Handle and insert the nail portion of the nail plate

into the proximal hole. The K-Wire should pass through the nail

plate’s screw hole as shown (Figure 7).

Once the nail portion is fully implanted, the driver handle is

detached and the nail plate inserter is removed.

The screw is then inserted over the guide wire through the

hole of the nail plate using the 1.5 mm Cannulated Hex Driver

(Blue and Gray Ringed, Catalog # TV230B) (Figure 8).

Following the guide wire’s path through the nail plate’s

screw hole, a compressive force is exerted as the screw

gains purchase.

NOTE 2: Do not over-tighten the screw. Once screw head is flush

with plate, stop turning. Do not reduce the nail plate to the bone

using the screw (Figure 9).

Micro Nail Plate with Inserter (Catalog # A2300B)

BioDrive™ Micro Nail Plate Surgical Technique (Continued)

Figure 7

Figure 9

Figure 8

The distal fragment is compressed as screw gains purchase.

11

Step 5: Wound Closure and Postoperative Care

Once the screw is fully seated, check final placement with

image intensification prior to capsular and incision closure.

Once the wound is closed, the extremity is then bandaged.

It is advisable to place lower extremity patients in a

postoperative shoe or boot during the return to weight bearing.

Patients are encouraged to perform range of motion exercises

in the early postoperative period.

12

Kit # 14-400170

Micro Nail Alignment Guide, Catalog # VA000B

Small Bone Holding Forceps, Catalog # 22894

Large Bone Holding Forceps, Catalog # 22896

Bone Reduction Forceps, Catalog # DA000B

Depth Gauge, Catalog # JA000B

Wire Depth Gauge, Catalog # 14-400171

Ergonomic Handle, Catalog # MV000B

Bone Lever, Catalog # SP000B

Baby Hohmann Retractor, Catalog # 14-401421

Tray Layout

13

Implant Caddy

Screw Drivers, Drill Bits and Countersinks

1. 2.0 mm Cannulated Hex Screw Driver (3.0 mm Screws), Catalog # TV300B

2. Cannulated Countersink (3.0 mm Screws), Catalog # FR300B

3. 1.9 mm Cannulated Drill Bit (3.0 mm Screws), Catalog # FT300B

4. 2.0 mm Solid Drill Bit (3.0 mm Screws), Catalog # FT301B

5. 1.5 mm Cannulated Hex Screw Driver (2.3 mm Screws/Nail Plate Screws), Catalog # TV230B

6. Cannulated Countersink (2.3 mm Screws), Catalog # FR230B

7. 1.6 mm Cannulated Drill Bit (2.3 mm Screws/Nail Plate Screws), Catalog # FT230B

8. 1.5 mm Solid Drill Bit (2.0 mm Screws), Catalog # FT150B

9. 1.5 mm Solid Hex Screw Driver (2.0 mm Screws), Catalog # TV200B

Micro Nail Plate Screws

2.3 mm BioDrive™ Micro Screws



Micro Nail Plates with Inserters, Catalog # A2300B

K-Wires, 0.8 x 120 mm (double-tipped), Catalog # BR101DT

1 2 3 4 5 6 7 8 9

14

Ordering Information

Implants

Catalog # Description Qty.

V2011B BioDrive™ Micro Bone Screw 2.0 mm L 11 mm 3


























A2311B BioDrive™ Micro Bone Screw for Micro Nail Plate 2.3 mm L 11 mm 3





A2300B BioDrive™ Micro - Micro Nail Plate 2

15

Instruments and Disposables

Catalog # Description Qty.

FT301B BioDrive™ Micro 2.0 mm Solid Drill Bit (3.0 mm Screws) 2

FR300B BioDrive™ Micro Cannulated Countersink (3.0 mm Screws) 1

FT300B BioDrive™ Micro 1.9 mm Cannulated Drill Bit (3.0 mm Screws) 2

TV300B BioDrive™ Micro 2.0 mm Cannulated Hex Screw Driver (3.0 mm Screws) 2

FR230B BioDrive™ Micro Cannulated Countersink (2.3 mm Screws) 1

FT230B BioDrive™ Micro 1.6 mm Cannulated Drill Bit (2.3 mm Screws/Nail Plate Screws) 2

TV230B BioDrive™ Micro 1.5 mm Cannulated Hex Screw Driver (2.3 mm Screws/Nail Plate Screws) 2

TV200B BioDrive™ Micro 1.5 mm Solid Hex Screw Driver (2.0 mm Screws) 2

FT150B BioDrive™ Micro 1.5 mm Solid Drill Bit (2.0 mm Screws) 2

MV000B BioDrive™ Micro Ergonomic Handle - Quick A.O. Coupling 1

JA000B BioDrive™ Micro Depth Gauge 1

VA000B BioDrive™ Micro Alignment Guide for Micro Nail Plate 1

DA000B BioDrive™ Micro Bone Reduction Forceps 1

SP000B BioDrive™ Micro Bone Lever 1

22894 Small Bone Holding Forceps 1

22896 Large Bone Holding Forceps 1

14-401421 Baby Hohmann Retractor 1

14-400171 Wire Depth Gauge 1

BR101DT BioDrive™ Micro 0.8 mm x 120 mm K-Wire (double-tipped) (5 Per Pack) 2

14-400169 Replacement Tray

Sterile Packed Disposables (Not included in set)

Catalog # Description

FT301BS BioDrive™ Micro 2.0 mm Solid Drill Bit (3.0 mm Screws) (Sterile)

FT300BS BioDrive™ Micro 1.9 mm Cannulated Drill Bit (3.0 mm Screws) (Sterile)

FT230BS BioDrive™ Micro 1.6 mm Cannulated Drill Bit (2.3 mm Screws) (Sterile)

FT150BS BioDrive™ Micro 1.5 mm Solid Drill Bit (2.0 mm Screws) (Sterile)

BR101DTS BioDrive™ Micro 0.8 mm x 120 mm K-Wire (Double-tipped) (5 Per Pack) (Sterile)

16

SterilizationThe BioDrive™ Micro Screw System is provided in both sterile and non-sterile configurations.

1. The sterile system is provided sterile using a minimum dosage of 2.5 megaRad (25 kGy) of gamma radiation. Where specified, do not use implants after expiration date.

2. The non-sterile system must be sterilized prior to use. All packaging materials must be removed prior to sterilization. Allcomponents should be sterilized in a loosened state such that components may move freely.

3. Re-sterilization of sterile products which have been opened is permissible as long as the components have not been previously implanted, not been exposed to biological contamination, nor appear to have compromised mechanical integrity.

The following steam sterilization parameters are recommended:

Cycle: Vacuum SteamTemperature: 270°F(132°C)Time: 8 minutesRecommended drying time: 20 minutes

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.

17

Further Information

This brochure describes a surgical technique used by Charles

Zelen, D.P.M. and Selene Parekh, M.D. Biomet Trauma as the

manufacturer of this device, 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 product(s) and

utilizing the appropriate technique(s) for said implantation

in each individual patient. The contents of this manual are

intended to be only a guide and are not intended to set a

standard of care.

CAUTION: Federal Law (USA) restricts this device to sale

by or on the order of a physician.

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

18

Notes:

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Notes:

20

Notes:

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Documents

BioDrive Micro Screw System - Zimmer Biomet · 1 Introduction Available in diameters of 2.0 mm, 2.3 mm and 3.0 mm, the BioDrive™ Micro Screw System offers a wide range of cannulated