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TRANSCRIPT
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.
Forerunner™ Plating System
©2013 Biomet Orthopedics • Form No. BMET0354.0 • 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.
Forerunner™ Plating System
Surgical Technique
Contents
Introduction .................................................... Page 1
Indications And Contraindications ................. Page 2
System Design Features ................................ Page 3
Instrumentation .............................................. Page 4
Tray Layout ..................................................... Page 8
Relevant Anatomy – Midfoot .......................... Page 9
Surgical Technique ........................................ Page 10
Surgical Technique For Lisfranc Fractures .... Page 14
Ordering Information ...................................... Page 16
Package Insert Information ............................ Page 18
Further Information ........................................ Page 21
1
Introduction
Implant Rationale
The Biomet Forerunner Plating System is a comprehensive
plating system designed for fixation of boney pathology
for the foot and ankle. The wide range of plates with varying
lengths between screw holes, as well as the multiple screw
diameters made available to the foot and ankle surgeon provide
for unlimited combinations for the unique and complicated
boney structure of the foot. In addition, providing non-locking,
fixed angle locking and poly-axial locking options provides the
surgeon even more choices for fixation of the most complex
deformities. The Forerunner Plating System can be used in
combination with many other foot and ankle products offered by
Biomet Trauma, including screws, Biomet® Vision™ FootRing™
System and XS Rail external fixation systems as well as a wide
range of osteobiologics and bone grafts to achieve optimized
foot and ankle reconstruction.
Source: Charles Zelen, D.P.M.
2
Indications And Contraindications
INDICATIONS
The Biomet® Forerunner Plating System is intended for adult
or pediatric patients as indicated for pelvic, small and long
bone fracture fixation and fixation of bones that have been
surgically prepared (osteotomy) for correction of deformity or
arthrodesis. Indications for use include internal fixation of the
tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna,
radius, middle hand and middle foot and forefoot bones.
Specific indications for midfoot/forefoot procedures:
1. Treatment of fractures and fracture dislocations of the
midfoot/forefoot
2. Malunions
3. Non-unions
4. Joint fusions/arthrodesis
5. Corrective osteotomies for deformities
These procedures in the midfoot/forefoot may be indicated as
a result of trauma, deformity, osteoarthritis and rheumatoid
arthritis.
Patient selection factors to be considered include:
1. Need for alignment and stabilization of bone fractures.
2. Ability and willingness of the patient to follow postoperative
care instructions until healing is complete.
3. A good nutritional state of the patient.
4. Vascular status of patient.
CONTRAINDICATIONS
1. Active infection.
2. Patient conditions including blood supply limitations, and
insufficient quantity or quality of bone.
3. Patients with mental or neurologic conditions who are
unwilling or incapable of following postoperative care
instructions or materials.
4. Foreign body sensitivity. Where material sensitivity is
suspected, testing is to be completed prior to implantation
of the device.
3
System Design Features
Plates And Screws
The Forerunner Plating System is a versatile system that
allows for constrained and semi-constrained fixation. This low
profile system features a one step locking mechanism and
a unique open design for intra-operative visualization of the
graft. This exclusive locking mechanism features SphereLock ™
technology that allows for simplified and secure locking.
SphereLock Technology
As the screw head advances into the recess of the plate,
the threads on the bone screw interlock with the threads
of the plate. The threads of the plate and the bone screw
resemble a sphere. In general, a spherical thread design has
the ability to self-center itself. In addition, a unique feature
of the Biomet Forerunner Plating System is the Variable Bone
Screw. The Variable Bone Screw features a poly-axial head.
The head is independent of the screw shaft and creates a 20°
cone of angulation.
• Titanium alloy provides strength and biocompatibility
• Locking and Non Locking options for the surgeon
• Fixed and Variable Angle options for screw placement
• Multiple screw diameters (4.0mm and 4.75mm)
• Screw lengths from 12mm through 50mm
• Plating options with 4, 6, 8 hole plates with variable distances between holes to optimize plating selection for the surgeon
Plates Available From 12mm To 66mm In Length
• 4-Hole Plate (12mm to 22mm)
• 6-Hole Plate (24mm to 42mm)
• 8-Hole Plate (44mm to 66mm)
• All Plates have a 1.9mm profile
Variable Bone Screw20°
Instrumentation
4
PN 14-401420Plate Bending Handles
PN 14-401416Reducer Sleeve
PN 14-4014172.5mm Temporary Fixator (Whirlybird)
PN 14-401413AO Screw Inserter Shaft (150mm)
PN 14-401424AO Screw Inserter Shaft (80mm)
PN 14-401414AO Awl Shaft
Temporary fixation device attachment
for precise placement of plate
in the foot and ankle
5
PN 14-401418Extreme Angle Plate Bender
PN 14-401419Mid-Plate Bender
PN 14-401422Baby Bennett Retractor
PN 14-401415Screw Depth Gauge
PN 14-401421Baby Hohman Retractor
PN 14-401423Screw Remover Lag Plate
Instrumentation (Continued)
6
PN 14-401425Fixed Drill Guide
PN 14-401426Variable Drill Guide
PN 14-401427Fixed Drill Guide Tube
PN 14-401428Variable Drill Guide Tube
7
PN 14-4014302.0mm x 150mm Drill
PN 14-4014312.8mm x 150mm Drill
PN 14-4014342.0mm x 230mm Drill
PN 14-4014352.8mm x 230mm Drill
Tray Layout
Instrumentation tray optimized for the foot and ankle surgeon
complete with AO compatible handles and specialized
instrumentation dedicated to the lower extremity surgeon.
Instrument Loaner Kit PN 14-401400
Instrument Sterilization Tray PN 14-401410
8
See page 16 for Complete Instrument and Implant Set List
Implant Loaner Kit PN 14-401401
Implant Sterilization Tray PN 14-401411
4-Hole Forerunner Plate Caddy
6-Hole Forerunner Plate Caddy
8-Hole Forerunner Plate Caddy
Forerunner Screw Caddy
BioDrive Implant Caddy1.6mm x 6” Threaded K-Wires
Relevant Anatomy – Midfoot
9
First Metatarsal
Second Metatarsal
Third Metatarsal
Fourth Metatarsal
Fifth Metatarsal
Lateral Cuneiform
Cuboid
Calcaneous
Medial Cuneiform
Intermediate Cuneiform
Navicular
Talus
Surgical Technique
10
Surgical Exposure of the Lateral Column
Reduction of Deformity, Placement of Bone Wedge, and
Propeller Head™ Screw for Compression
Source: Charles Zelen, D.P.M.
Step 1 - Surgical Exposure
The dissection and surgical exposure are determined by
the boney segments to be stabilized and the severity of the
deformity. Sufficient exposure for insertion of the plates and
screws is recommended unless a percutaneous technique is
being utilized.
NOTE: Unnecessary tension on the skin and soft tissue
structures is not recommended since this may lead
to wound dehiscence and breakdown.
Step 2 - Deformity Correction
Once exposure of the boney segments is obtained, appropriate
boney resections are then performed and deformity is then
corrected. In some cases, bone grafting may be utilized to
assist in achieving optimal correction of deformity. In fusion
procedures the surgeon may consider the use of cannulated
screws for compression of the boney fragments prior to
placing the Forerunner plates into position.
11
Step 3 - Preparation Of Forerunner Plate
The Forerunner Plating System offers unique Plate Benders
(PN 14-401420) that allow for an exact contour of the plate
specific for the foot and ankle deformity to be addressed.
Step 4 - Application Of The Forerunner Plate
A specialized instrument is included in the system for
placement of the Forerunner plate known as the Temporary
Fixation Device (PN 14-401416 and PN 14-401417).
This instrument will assist the surgeon in exact placement of
the plate as well as assist in close adherence of the plate to
the bone interphase and prevent prominence of the plate on
the surrounding soft tissues. One or two of these devices can
be used based on surgeon preference.
Bending of the plate to contour to the boney surface
PN 14-401420
Use of the temporary fixation device for plate adherence
to bone
Source: Charles Zelen, D.P.M.
PN 14-401416PN 14-401417
Surgical Technique (Continued)
12
Step 5 - Placement Of Screws
The surgeon may choose non-locking, fixed angle locking
or poly-axial locking screws. In addition, the surgeon has
the option of the 4.0mm standard or 4.75mm relief screw.
The lengths of the screws range in total from 10mm to 50mm.
All the screws within the Forerunner Plating System are self
drilling and self tapping, however in hard bone the surgeon
may choose to drill. A drill guide is available to pre-drill with
a specialized Variable Angle Drill Guide (PN 14-401426 or PN
14-401428) for use with the poly-axial locking screws. The
variable angle guide should sit firmly into the drill hole to
ensure that the screw is not inserted beyond the 20 degree
cone of angulation required for achieving locking.
NOTE: In addition, the drill bit is calibrated so that the surgeon
can measure directly from the drill bit to prevent the need for
use of another measuring device.
Use of the Variable Angle Drill Guide
A close up view of the variable angle locking screw
prior to insertion
Source: Charles Zelen, D.P.M.
13
Placement Of Screws (Continued)
Insertion of the variable angle locking screw into the
Forerunner plate
Final insertion of six variable angle locking screws into the
lateral column with a six-hole Forerunner plate
Final insertion of four variable angle locking screws into the
medial column with a four-hole Forerunner plate
Source: Charles Zelen, D.P.M.
Surgical Technique For Lisfranc Fractures
14
Introduction
A plate applied to the plantar (tension) side of the medial
midfoot provides a strong, sturdy construct for arthrodesis
and ambulation after Lisfranc’s dislocation. The tension
side is able to maintain correction over high and repetitive
loading, which is ideal for arthrodesis and early ambulation of
neuropathic joints. Research has shown that a plate applied
to the plantar (tension) aspect of the medial midfoot provides
a stronger, sturdier construct than does midfoot fusion with
screw fixation.* Studies have also revealed that a plantar plate
allows significantly less initial displacement and maintains
stabilization at a much higher load. By maintaining correction
over high and repetitive loading, the patient should be able to
ambulate earlier while maintaining arthrodesis.
Technique
Step 1 - Patient Positioning
Patients are taken to the operating room and placed in a
supine position. Following admission of general anesthesia,
cotton padding is placed over the upper thigh of the foot being
operated on and a pneumatic thigh tourniquet is applied. The
foot is then prepped and draped in the usual sterile manner.
Step 2 - Incision 1
The tourniquet is applied and elevated. Attention is directed to
the Achilles tendon where a linear incision is made over the
distal 1/3 of the leg.
The tendoachilles lengthening is performed. Approximately
2cm of lengthening is achieved. The paratenon was
re-approximated using 3.0 vicryl. The subcutaneous tissue
is closed using 3.0 vicryl, skin was closed in a horizontal
mattress type stitch using 4.0 nylon.
Step 3 - Incision 2
Attention is then directed to the planter medial aspect of the foot.
A straight incision is made beginning at the talonavicular joint
and extending to the distal one-third of the 1st metatarsal shaft.
The incision is deepened via sharp and blunt dissection
down to the 1st metatarsal, medial cuneiform, and
navicular. A full thickness tissue flap is reflected off of the
tarsometatarsal joints.
15
Step 4 - Necrotic Bone Removal
Attention is directed to the base of Lisfranc’s articulation.
An osteotome is used to remove approximately 1.0cm block
of necrotic bone across Lisfranc’s joint, down to good healthy
bleeding bone. If necessary, a second incision can be made
on the lateral aspect of the foot between the 4th and 5th
metatarsals. This incision is deepened down to the base of
the metatarsals and cuboid. All necrotic bone from lateral to
medial is removed, completing the resection of neuropathic
bone across Lisfranc’s joint.
The same procedure is performed through the innominate i.e.
naviculo-cuneiform joints, depending on the extension
of neuroarthropathy destruction, in order to restore the medial
arch of the foot.
Step 5 - Plate Insertion
The Lisfranc’s joint is adducted and held into a plantar flexed
position using two 1.6mm Wires (PN 245020) for temporary
fixation. Next, the Forerunner plate is eccentrically loaded and
applied to the plantar aspect of the first metatarsal, medial
cuneiform and navicular.
One cortical screw is placed outside of the Forerunner plate
in an oblique fashion, seating on the medial wall of the first
metatarsal and aiming at the lateral edge of the navicular.
Its length depends on the extension of the debrided region.
A second cortical screw is inserted outside of the Forerunner
plate from the medial cuneiform or navicular into the 2nd or
3rd metatarsal base. No fixation is used on the 4th and 5th
rays. Autogenous cancellous bone might be used to fill any
void or space at the arthrodesis site.
Step 6 - Wound Closure And Dressing
The incisions are then dressed using betadine soaked adaptic,
4 x 4’s, and kling. A dry sterile dressing is applied, followed by
a posterior splint or Jones compression dressing.
16
Ordering Information
Instruments
Catalog # Description Qty.
14-401410 Instrument Tray 1
14-401411 Implant Tray 1
14-401415 Screw Depth Gauge 1
14-401413 AO Screw Inserter Shaft (150mm) 1
14-401414 AO Awl Shaft 1
14-401418 Extreme Angle Plate Bender 1
14-401420 Plate Bending Handles 2
14-401425 Drill Guide (Fixed) 1
14-401426 Drill Guide (Variable) 1
14-401427 Drill Guide Tube (Fixed) 2
14-401428 Drill Guide Tube (Variable) 2
14-401421 Baby Hohman 2
14-401422 Baby Bennett 2
14-401424 AO Screw Inserter Shaft (80mm) 2
22894 Small Bone Reducing Forceps 1
22896 Large Bone Reducing Forceps 1
14-401416 Reducer Sleeve 2
22880 AO Ratcheting Handle 2
14-401423 Screw Remover Lag Plate 1
14-401419 Mid-Plate Bender 1
14-401417 Temporary Fixator (Whilybird - 2.5mm) 2
14-401430 2.0mm x 150mm Drill 2
14-401434 2.0mm x 230mm Drill 1
14-401431 2.8mm x 150mm Drill 1
14-401435 2.8mm x 230mm Drill 1
Plates
Catalog # Description Qty.
14-401112 4-Hole Plate - 12mm Length 2
14-401114 4-Hole Plate - 14mm Length 2
14-401116 4-Hole Plate - 16mm Length 2
14-401118 4-Hole Plate - 18mm Length 2
14-401120 4-Hole Plate - 20mm Length 2
14-401122 4-Hole Plate - 22mm Length 2
Plates (Continued)
Catalog # Description Qty.
14-401224 6-Hole Plate - 24mm Length 2
14-401226 6-Hole Plate - 26mm Length 2
14-401228 6-Hole Plate - 28mm Length 2
14-401230 6-Hole Plate - 30mm Length 2
14-401232 6-Hole Plate - 32mm Length 2
14-401234 6-Hole Plate - 34mm Length 2
14-401236 6-Hole Plate - 36mm Length 2
14-401238 6-Hole Plate - 38mm Length 2
14-401240 6-Hole Plate - 40mm Length 2
14-401242 6-Hole Plate - 42mm Length 2
14-401344 8-Hole Plate - 44mm Length 2
14-401346 8-Hole Plate - 46mm Length 1
14-401348 8-Hole Plate - 48mm Length 2
14-401350 8-Hole Plate - 50mm Length 1
14-401352 8-Hole Plate - 52mm Length 2
14-401354 8-Hole Plate - 54mm Length 1
14-401356 8-Hole Plate - 56mm Length 2
14-401358 8-Hole Plate - 58mm Length 1
14-401360 8-Hole Plate - 60mm Length 2
14-401362 8-Hole Plate - 62mm Length 1
14-401364 8-Hole Plate - 64mm Length 2
14-401366 8-Hole Plate - 66mm Length 1
4.0mm Locking Variable Self-Drilling Screws
Catalog # Description Qty.
14-401512 4.0mm x 12mm 4
14-401514 4.0mm x 14mm 4
14-401516 4.0mm x 16mm 8
14-401518 4.0mm x 18mm 8
14-401520 4.0mm x 20mm 8
14-401522 4.0mm x 22mm 8
14-401524 4.0mm x 24mm 8
14-401526 4.0mm x 26mm 8
14-401528 4.0mm x 28mm 8
14-401530 4.0mm x 30mm 8
14-401535 4.0mm x 35mm 4
17
4.0mm Locking Variable Self-Drilling Screws (Continued)
Catalog # Description Qty.
14-401540 4.0mm x 40mm 4
14-401545 4.0mm x 45mm 0*
14-401550 4.0mm x 50mm 0*
* The part is not included in set, but can be ordered separately.
4.75mm Locking Variable Salvage Screws
Catalog # Description Qty.
14-401712 4.75mm x 12mm 0*
14-401714 4.75mm x 14mm 0*
14-401716 4.75mm x 16mm 0*
14-401718 4.75mm x 18mm 0*
14-401720 4.75mm x 20mm 0*
14-401722 4.75mm x 22mm 0*
14-401724 4.75mm x 24mm 0*
14-401726 4.75mm x 26mm 0*
14-401728 4.75mm x 28mm 0*
14-401730 4.75mm x 30mm 0*
14-401735 4.75mm x 35mm 0*
14-401740 4.75mm x 40mm 0*
14-401745 4.75mm x 45mm 0*
14-401750 4.75mm x 50mm 0*
* The part is not included in set, but can be ordered separately.
4.0mm Locking Fixed Self-Drilling Screws
Catalog # Description Qty.
14-401612 4.0mm x 12mm 4
14-401614 4.0mm x 14mm 4
14-401616 4.0mm x 16mm 8
14-401618 4.0mm x 18mm 8
14-401620 4.0mm x 20mm 8
14-401622 4.0mm x 22mm 8
14-401624 4.0mm x 24mm 8
14-401626 4.0mm x 26mm 8
14-401628 4.0mm x 28mm 8
14-401630 4.0mm x 30mm 8
14-401635 4.0mm x 35mm 4
14-401640 4.0mm x 40mm 4
14-401645 4.0mm x 45mm 0*
14-401650 4.0mm x 50mm 0*
* The part is not included in set, but can be ordered separately.
4.0mm Non-Locking Fixed Self-Drilling Screws
Catalog # Description Qty.
14-402012 4.0mm x 12mm 2
14-402014 4.0mm x 14mm 2
14-402016 4.0mm x 16mm 2
14-402018 4.0mm x 18mm 2
14-402020 4.0mm x 20mm 2
14-402022 4.0mm x 22mm 2
14-402024 4.0mm x 24mm 2
14-402026 4.0mm x 26mm 2
14-402028 4.0mm x 28mm 2
14-402030 4.0mm x 30mm 2
14-402035 4.0mm x 35mm 2
14-402040 4.0mm x 40mm 2
14-402045 4.0mm x 45mm 0*
14-402050 4.0mm x 50mm 0*
* The part is not included in set, but can be ordered separately.
4.75mm Non-Locking Fixed Self-Drilling - Salvage Screws
Catalog # Description Qty.
14-402212 4.75mm x 12mm 0*
14-402214 4.75mm x 14mm 4
14-402216 4.75mm x 16mm 0*
14-402218 4.75mm x 18mm 4
14-402220 4.75mm x 20mm 0*
14-402222 4.75mm x 22mm 4
14-402224 4.75mm x 24mm 0*
14-402226 4.75mm x 26mm 4
14-402228 4.75mm x 28mm 0*
14-402230 4.75mm x 30mm 4
14-402235 4.75mm x 35mm 4
14-402240 4.75mm x 40mm 4
14-402245 4.75mm x 45mm 0*
14-402250 4.75mm x 50mm 0*
* The part is not included in set, but can be ordered separately.
Package Insert Information
18
DESCRIPTION
Biomet® manufactures a variety of internal fixation devices
intended to aid in the alignment and stabilization of fractures
to the skeletal system. These implantable devices include bone
screws and bone plates. Instrumentation has been designed
specifically for use with each system of implants.
MATERIALS
Titanium Alloy
INDICATIONS
The Biomet® Forerunner Plating System is intended for adult
or pediatric patients as indicated for pelvic, small and long
bone fracture fixation and fixation of bones that have been
surgically prepared (osteotomy) for correction of deformity or
arthrodesis. Indications for use include internal fixation of the
tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna,
radius, middle hand and middle foot and forefoot bones.
Specific indications for midfoot/forefoot procedures:
1. Treatment of fractures and fracture dislocations of the
midfoot/forefoot
2. Malunions
3. Non-unions
4. Joint fusions/arthrodesis
5. Corrective osteotomies for deformities
These procedures in the midfoot/forefoot may be indicated as
a result of trauma, deformity, osteoarthritis and rheumatoid
arthritis.
Patient selection factors to be considered include:
1. Need for alignment and stabilization of bone fractures.
2. Ability and willingness of the patient to follow postoperative
care instructions until healing is complete.
3. A good nutritional state of the patient.
4. Vascular status of patient.
CONTRAINDICATIONS
1. Active infection.
2. Patient conditions including blood supply limitations, and
insufficient quantity or quality of bone.
3. Patients with mental or neurologic conditions who are
unwilling or incapable of following postoperative care
instructions or materials.
4. Foreign body sensitivity. Where material sensitivity is
suspected, testing is to be completed prior to implantation
of the device.
WARNINGS
Internal fixation devices aid the surgeon in the alignment
and stabilization of skeletal fractures and provide a means of
fracture management in reconstructive surgical applications.
While these devices are generally successful in attaining these
goals, they cannot be expected to replace normal healthy bone
or withstand the stress placed upon the device by full or partial
weight bearing or load bearing, particularly in the presence of
nonunion, delayed union, or incomplete healing. Metallic bone
fixation devices are internal splints that align the fracture until
normal healing occurs. The size and shape of bones and soft
tissue place limitations on the size and strength of implants. If
there is delayed union or nonunion of bone in the presence of
weight bearing, or load bearing, the implant could eventually
break. Therefore, it is important that immobilization (use of
external support, walking aids, braces, etc.) of the fracture site
be maintained until firm bony union (confirmed by clinical and
radiographic examination) is established. Surgical implants are
subject to repeated stresses in use, which can result in fatigue
fracture. Factors such as the patient’s weight, activity level,
and adherence to weight bearing or load bearing instructions
have an effect on the service life of the implant. The surgeon
must be thoroughly knowledgeable not only in the medical and
surgical aspects of the implant, but also must be aware of the
mechanical and metallurgical aspects of the surgical implants.
19
1. Correct selection of the implant is extremely important.
The potential for success in fracture fixation is
increased by the selection of the proper type of implant.
While proper selection can help minimize risks, the size
and shape of human bones present limitations on the size
and strength of implants. Internal fixation devices cannot
withstand the activity levels and/or loads equal to those
placed on normal healthy bone. These devices are not
designed to withstand the unsupported stress of full weight
bearing, or load bearing.
2. The devices can break when subjected to increased loading
associated with nonunion or delayed union. Internal fixation
devices are load-sharing devices that hold a fracture in
alignment until healing occurs. If healing is delayed, or
does not occur, the implant can be expected to break,
bend or fail. Loads produced by weight bearing, and activity
levels may dictate the longevity of the implant.
3. Implant materials are subject to corrosion. Implanting
metals and alloys subjects them to constant changing
environments of salts, acids, and alkalis that can cause
corrosion. Putting dissimilar metals and alloys in contact
with each other can accelerate the corrosion process that
may enhance fracture of implants. Every effort should be
made to use compatible metals and alloys when marrying
them to a common goal, i.e., screws and plates.
4. Correct handling of implants is extremely important. Do not
modify implants. Do not notch or bend implants. Notches or
scratches put in the implant during the course of surgery
may contribute to breakage. Intraoperative fracture of
screws can occur if excessive force (torque) is applied
while seating bone screws.
5. Remove after fracture has healed. Implants can loosen,
fracture, corrode, migrate, or cause pain. If an implant remains
implanted after complete healing, the implant may cause
stress shielding, which may increase the risk of refracture in
an active patient. The surgeon should weigh the risks versus
benefits when deciding whether to remove the implant.
Adequate postoperative management to avoid refracture
should follow implant removal.
6. Adequately instruct the patient. Postoperative care is
important. The patient’s ability and willingness to follow
instruction is one of the most important aspects of
successful fracture management. Patients with senility,
mental illness, alcoholism, and drug abuse may be at
higher risk. These patients may ignore instructions and
activity restrictions. The patient is to be instructed in the
use of external supports, walking aids, and braces that
are intended to immobilize the fracture site and limit
weight bearing or load bearing. The patient is to be made
fully aware and warned that the device does not replace
normal healthy bone, and that the device can break, bend
or be damaged as a result of stress, activity, load bearing,
or weight bearing. The patient is to be made aware and
warned of general surgical risks, possible adverse effects,
and to follow the instructions of the treating physician.
The patient is to be advised of the need for regular
postoperative follow-up examination as long as the device
remains implanted.
7. In pediatric patients, care should be taken to avoid the
growth plate during plate/screw insertion.
8. Patient smoking may result in delayed healing, non-healing
and/or compromised stability in or around the placement site.
PRECAUTIONS
Device is single use only.
Do not reuse implants. While an implant may appear
undamaged, previous stress may have created imperfections
that would reduce the service life of the implant.
Do not treat patients with implants that have been even
momentarily placed in a different patient.
Instruments are available to aid in the accurate implantation of
internal fixation devices. Intraoperative fracture or breaking of
instruments has been reported.
Package Insert Information (Continued)
20
Surgical instruments are subject to wear with normal usage.
Instruments which have experienced extensive use or excessive
force are susceptible to fracture. Surgical instruments
should only be used for their intended purpose. Biomet
recommends that all instruments be regularly inspected for
wear and disfigurement.
All trial, packaging, and instrument components must be
removed prior to closing the surgical site. Do not implant.
POSSIBLE ADVERSE EFFECTS
1. Nonunion or delayed union, which may lead to breakage
of the implant.
2. Bending or fracture of the implant.
3. Loosening or migration of the implant.
4. Metal sensitivity, or allergic reaction to a foreign body.
5. Decrease in bone density due to stress shielding.
6. Pain, discomfort, or abnormal sensation due to the
presence of the device.
7. Nerve damage due to surgical trauma.
8. Necrosis of bone.
9. Postoperative bone fracture and pain.
10. Inadequate healing.
11. Early or late postoperative infection and/or
allergic reaction.
MAGNETIC RESONANCE (MR) STATEMENT
The effects of the MR environment have not been determined
for this device. This device has not been tested for heating or
migration in the MR environment.
STERILITY
The Forerunner Plating 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. All
components 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:
Pre-Vacuum Steam Sterilization:
Temperature: 270°F (132°C)
Time: Eight (8) Minutes
Drying Time: Twenty (20) Minutes
NOTE: Allow for Cooling
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.
CAUTION: Federal law (USA) restricts this device to sale by or on
the order of a physician.
Comments regarding this device can be directed to Attn:
Regulatory Dept., Biomet Inc., P.O. Box 587, Warsaw, IN 46581
USA, FAX: 574-372-3968.
All trademarks herein are the property of Biomet, Inc. or its
subsidiaries unless otherwise indicated.
Further Information
21
This brochure describes a surgical technique used by Charles
Zelen, D.P.M. and Larry Didominico, D.P.M. 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
22
Notes:
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Notes:
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Notes: