SBFS Small Bone Fixation System

Surgical Technique
SBFS Small Bone Fixation System
Introduction

The Small Bone Fixation System is a percutaneous locked This material represents the surgical technique utilized
flexible intramedullary nail system for hand and foot by Brian Hartigan, M.D. (now deceased) and Lloyd
fractures. This self-contained system is provided in a sterile Champagne, M.D. Biomet does not practice medicine.
pack with the implant and instruments in a small tray to The treating surgeon is responsible for determining the
help reduce OR clutter and surgical time. The nails tapered appropriate treatment, technique(s), and product(s) for
and contoured design is intended to facilitate negotiating each individual patient.
the proximal fragment and assist its introduction into the
distal fragment. The nail is available in 2 diameters to
better match the patients size. The shape can be adjusted
to provide 3-point fixation and the locking mechanism
stabilizes rotation and length. An implantable nail cap
covers the cut nail to help avoid soft tissue irritation. The
simple surgical technique utilizes a smaller incision than
plating, minimizing the length of the resultant scar.

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Small Bone FixationSimplified

1 intramedullary nail available in 2 diameters: Slotted awl for nail insertion

0.045" (1.1 mm) nail diameter
0.062" (1.6 mm) nail diameter

1 implantable nail cap Locking Device Nail exchanger and

Helps avoid soft tissue irritation For rotational stability bending tool

Indications for Use

Self contained, pre-sterile kit is ready when you are For the fixation of extra-articular fractures of the long bones
1 part number per procedure for simplified of the hand including the metacarpals and the proximal and
inventory management middle phalanges, and the metatarsal bones of the foot.
Eliminates the need for power equipment, helping to
reduce surgical time and costs
3 points of fixation create rotational stability without
violating the joint space

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Small Bone Fixation System
Surgical Technique

Surgical Approach Reduce the Fracture

On metacarpals 2 and 5, the extensor tendons are easily The nail comes tapered and contoured to facilitate
avoided by approaching from a dorsal or lateral direction negotiating the proximal fragment and its introduction
On metacarpals 3 and 4, the approach is generally into the distal fragment
straight dorsal and the extensor tendons must be Advance the nail manually until the tip is just proximal
separated bluntly with a hemostat to the fracture site
Proximal phalanx fractures can be approached from Reduce the fracture using fluoroscopy and pass the
a dorsal or lateral portal nail into the distal fragment
Advance the nail to the head of the metacarpal
Obtain Percutaneous Access or phalanx
to the Medullary canal Transverse diaphyseal fractures should be manually
impacted to prevent over-distraction
Utilize fluoroscopy to place the tip of the awl 5mm
distal to the proximal joint surface
Perforate the first cortex of the bone manually and
then stop
Push the nail handle with the thumb, which will
advance it into the medullary canal. In the same
motion, pull back on the awl with your fingers and
remove it from the canal

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 Insertion
Re-Insertion
Nail Exchange
The shape of the nail may need adjustment in order to
enter the distal fragment or to provide 3-point fixation
Use the slotted nail exchange portion in the
accessory tool to insert under the nail and into the
medullary canal
Remove the nail, while keeping the accessory tool
inside the canal
Adjust the shape of the nail with sterile pliers
Re-insert the nail over the slotted portion of the
accessory tool
Remove the accessory tool
Cutting the Nail
Bending the Nail
Advance and Cut the Nail
Once the surgeon is satisfied with fracture reduction
and fixation, cut the nail from the handle
Utilize the tubular end of the accessory tool to bend
the nail approximately 7090
Note: If rotational stability is not a concern, the end
cap can be placed on the nail and the incision can be
closed.
Note: Ensure the nail is cut distal to the bevel/taper
located near the insertion handle to avoid difficulty
when sliding the locking sleeve over the tip of the nail.
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Small Bone Fixation System

Insert the Locking Device
Utilize fluoroscopy to insert the locking device,
making sure not to trespass the opposite cortex
Slightly tap the locking sleeve with a small mallet to
fully seat the tip into the opposite cortex
Cut the nail and locking device together
Place Protective Implantable Cap on the Nail
The use of the radiopaque implantable nail cap is
designed to reduce the risk of soft tissue irritation,
particularly tendon irritation in metacarpals 3 & 4
Introduce the cap over the cut end of the nail and
seat it fully by digital pressure

Note: The surgeon can elect to cut the implant above

or below the skin. If cut below the skin, it is important
to leave the cut end of the nail at a more superficial
level than the extensor tendons to prevent possible
irritation and to facilitate removal.

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Suggested Post-Op Instructions
1. Instruct the patient to wear a removable splint or
soft cast with thin plaster covering for 14 weeks,
depending on type of fracture, fixation and stability;
Smaller splints with less hindrance to the MCP (and
PIP) joints with stable fixation in reliable patients may
be more appropriate.
2. Allow early, gentle motion exercises after 110 days
post-op.
3. In most cases, a splint will not be necessary after
4 weeks.
4. If the nail is left above the skin, general wound
management will be required around the incision site
until it is removed.
Removal Instructions
1. After 46 weeks, have the patient return to the office
for pin removal.
2. Most nail removals should be done in the OR under
anesthesia.
3. If the nail was cut short and left under the skin, make
a small stab incision to expose the cap.
4. Remove the radiopaque cap from the nail with pliers.
5. Use pliers to remove the locking sleeve first (if it was
used) by pulling the nail vertically; you may need to
slightly rotate the locking sleeve back and forth around
the nail with the pliers as youre pulling up, in order to
free the two pieces from each other.
6. Once the locking sleeve is removed, use pliers to pull
the nail proximally, via the same path that was used
to insert it initially. You will experience resistance while
removing the nail, depending on the amount of time
the bone has had to heal around the nail.
7. After successful nail removal, close the stab incision.
Removal Tips and Pearls
During the insertion phase, removal strategy should be
pre-planned. Leaving exposed hardware or superficial
hardware makes an in-office removal possible and
perhaps easier. If a period of longer fixation is anticipated
(>56 weeks), consider cutting the pin very deep to
avoid pin site infections; deep pins should be removed
in the O.R., under general anesthesia.
The SBFS is an intramedullary (IM) device, not a
k-wire. It is designed to maximize stability in the IM
canal by allowing for 3-point fixation and length and
rotational control. Therefore, there will be resistance
when removing the nail. That is part of the design and
should reassure you that the SBFS provides a stable
construct from which the fracture may heal.
If you feel that you are having an increasingly hard time
removing the nail, try bending the proximal end of the
nail when it is initially inserted into the IM canal only
6070 (vs. 90). This will help the bend in the nail slide
out more easily. DO NOT BEND THE NAIL AS YOU ARE
REMOVING IT! This can potentially lead to a re-fracture
at the nail entry site.
If you wish to perform the removal under local anesthesia
in the exam room, give some thought to your patient
selection since they will experience discomfort and
possibly pain. A nerve block, administered by the
surgeon, is also recommended.
The above content was provided by Brian Hartigan, M.D.
(now deceased) and Lloyd Champagne, M.D. Biomet does
not practice medicine. The treating surgeon is responsible
for determining the appropriate treatment, technique(s),
product(s), and post-operative protocol for each individual
patient.
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INDICATIONS: Ordering Information
The Small Bone Fixation System is indicated for the fixation of
extra-articular fractures of the long bones of the hand including Small Bone Fixation System Standard Pack includes:
metacarpals and the proximal and middle phalanges, and the SBFS045 Size: 0.045" (1.1 mm) nail diameter
metatarsal bones of the foot.
SBFS062 Size: 0.062" (1.6 mm) nail diameter
CONTRAINDICATIONS: Each Standard Pack includes:
Fractures with insufficient size for fixation 1 Intramedullary Nail
Fractures involving the articular surface 1 Slotted Awl
1 Nail Exchanger/Bending Tool
1 Locking Device
1 Implantable Nail Cap

Small Bone Fixation Nail Replacement Pack includes:

SBFN045 Size: 0.045" (1.1 mm) nail diameter
SBFN062 Size: 0.062" (1.6 mm) nail diameter
Each Replacement Pack includes:
1 Intramedullary Nail
1 Locking Device
1 Implantable Nail Cap
For use in patients with multiple fractures

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force only. Distribution to any other recipient is prohibited. All content herein is
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by or licensed to Biomet Inc. or its affiliates unless otherwise indicated. This material
must not be redistributed, duplicated or disclosed, in whole or in part, without the
express written consent of Biomet.

Check for country product clearances and reference product specific instructions
for use. For complete product information, including indications, contraindications,
warnings, precautions, and potential adverse effects, see the package insert and
Biomets website.

This technique was prepared in conjunction with a licensed health care professional.
Biomet does not practice medicine and does not recommend any particular
orthopedic implant or surgical technique for use on a specific patient. The surgeon
is responsible for determining the appropriate device(s) and technique(s) for each
individual patient.

Not for distribution in France.

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