BioDrive Micro Screw System - Zimmer Biomet · 1 Introduction Available in diameters of 2.0 mm, 2.3...
Transcript of BioDrive Micro Screw System - Zimmer Biomet · 1 Introduction Available in diameters of 2.0 mm, 2.3...
At Biomet, engineering excellence is our heritage
and our passion. For over 25 years, through various
divisions worldwide, we have applied the most
advanced engineering and manufacturing technology
to the development of highly durable systems for
a wide variety of surgical applications.
To learn more about this product,
contact your local Biomet Sales Representative today.
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
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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)
3.0 mm BioDrive™ Micro Screw (Cannulated)
• 0.95 mm Plate Thickness
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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.
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Implant Specifications
2.3 mm BioDrive™ Micro Screw (Cannulated)
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
Shaft Diameter: 1.2 mm
Proximal Thread Pitch: 0.6 mm
Distal Thread Pitch: 0.8 mm
Diameter: 2.0 mm
Diameter: 3.4 mm
2.0 mm BioDrive™ Micro Screw (Solid)
Lengths: 11 mm -14 mm (1.0 mm increments)
Drill Bit Used: Catalog # FT150B
(1.5 mm Solid Drill Bit, Gray Ringed)
Screw Driver Used: Catalog # TV200B
(Solid 1.5 mm Hex Screw Driver, Green Ringed)
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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)
3.0 mm BioDrive™ Micro Screw (Cannulated)
Lengths: 10 mm -32 mm (2.0 mm increments)
Drill Bit Used: Catalog # FT300B
(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)
Shaft Diameter: 1.9 mm
Proximal Thread Pitch: 1.05 mm
Distal Thread Pitch: 1.25 mm
Diameter: 3.0 mm
Diameter: 4.7 mm
Micro Nail Plate with Inserter
(Catalog # A2300B)
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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
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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)
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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
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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
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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
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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.
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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.
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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
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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
2.0 mm BioDrive™ Micro Screws
3.0 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
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Ordering Information
Implants
Catalog # Description Qty.
V2011B BioDrive™ Micro Bone Screw 2.0 mm L 11 mm 3
V2012B BioDrive™ Micro Bone Screw 2.0 mm L 12 mm 3
V2013B BioDrive™ Micro Bone Screw 2.0 mm L 13 mm 3
V2014B BioDrive™ Micro Bone Screw 2.0 mm L 14 mm 3
V2310B BioDrive™ Micro Bone Screw 2.3 mm L 10 mm 3
V2312B BioDrive™ Micro Bone Screw 2.3 mm L 12 mm 3
V2314B BioDrive™ Micro Bone Screw 2.3 mm L 14 mm 3
V2316B BioDrive™ Micro Bone Screw 2.3 mm L 16 mm 3
V2318B BioDrive™ Micro Bone Screw 2.3 mm L 18 mm 3
V2320B BioDrive™ Micro Bone Screw 2.3 mm L 20 mm 3
V2322B BioDrive™ Micro Bone Screw 2.3 mm L 22 mm 3
V2324B BioDrive™ Micro Bone Screw 2.3 mm L 24 mm 3
V2326B BioDrive™ Micro Bone Screw 2.3 mm L 26 mm 3
V2328B BioDrive™ Micro Bone Screw 2.3 mm L 28 mm 3
V3010B BioDrive™ Micro Bone Screw 3.0 mm L 10 mm 3
V3012B BioDrive™ Micro Bone Screw 3.0 mm L 12 mm 5
V3014B BioDrive™ Micro Bone Screw 3.0 mm L 14 mm 6
V3016B BioDrive™ Micro Bone Screw 3.0 mm L 16 mm 6
V3018B BioDrive™ Micro Bone Screw 3.0 mm L 18 mm 4
V3020B BioDrive™ Micro Bone Screw 3.0 mm L 20 mm 3
V3022B BioDrive™ Micro Bone Screw 3.0 mm L 22 mm 3
V3024B BioDrive™ Micro Bone Screw 3.0 mm L 24 mm 3
V3026B BioDrive™ Micro Bone Screw 3.0 mm L 26 mm 2
V3028B BioDrive™ Micro Bone Screw 3.0 mm L 28 mm 2
V3030B BioDrive™ Micro Bone Screw 3.0 mm L 30 mm 2
V3032B BioDrive™ Micro Bone Screw 3.0 mm L 32 mm 2
A2311B BioDrive™ Micro Bone Screw for Micro Nail Plate 2.3 mm L 11 mm 3
A2312B BioDrive™ Micro Bone Screw for Micro Nail Plate 2.3 mm L 12 mm 3
A2313B BioDrive™ Micro Bone Screw for Micro Nail Plate 2.3 mm L 13 mm 3
A2314B BioDrive™ Micro Bone Screw for Micro Nail Plate 2.3 mm L 14 mm 3
A2315B BioDrive™ Micro Bone Screw for Micro Nail Plate 2.3 mm L 15 mm 3
A2300B BioDrive™ Micro - Micro Nail Plate 2
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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)
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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.
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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
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Notes:
19
Notes:
20
Notes:
C