S3® Proximal Humerus Plate Shoulder Plating System - Biomet

S 3®
Proximal Humerus Plate
Shoulder Plating System
Product Overview

S 3® Proximal Humerous Plate Shoulder Plating System
Restoration of the Anatomy
• Precisely contoured plates are designed to mirror the
complex shape of the proximal humerus
• The S3 plate is designed to act as a reduction template
to help restore the anatomy
• Multiple 4.0 mm subchondral support pegs & screws
maintain fracture reduction
Designed for Low Risk
of Subacromial Impingement
• The S3 plate is designed to be positioned approximately
3.0 cm distal to the greater tuberosity, preventing
subacromial impingement
• Anatomically contoured undersurface aids in restoring
proper humeral head rotation
Strong and Stable Construct
• Precise fixed angle peg distribution provides spatial
subchondral support to resist varus forces throughout
the full range of motion
• Proximal and distal locking screws and pegs permit a
strong interface for a secure and stable construct
• Blunt-tipped subchondral support pegs provide stability
while preventing protrusion through the articular
surface
Designed for Predictable
and Reproducible Results
• Central guiding K-wire provides visual confirmation for
plate positioning
• Manually inserted, blunt-tipped drill bits helps provide
protection against the potential perforation of the articular
surface
• Predetermined peg trajectories allow a consistent
spatial distribution within the humeral head
2

Simplified Soft Tissue Fixation
• Uniquely designed suture holes allow tuberosity repairs
after humeral head fixation
• Suture holes are designed to accomodate multiple
passes for extensive soft tissue fixation
F.A.S.T. Guide Technology
• Pre-loaded single use disposable drill guides
• No intraoperative assembly required, resulting in significant
time savings
• F.A.S.T. Guides are color-coded for easy plate identification:
Red=Right / Lime=Left
Surgical Technique Overview
See Surgical Technique, Cat. No. 0612-00-565 for details of the complete procedure.
Through a 12 cm to 14 cm incision, develop the deltopectoral
interval.
Debride then reduce the fracture through traction and
manipulation.
Position the plate approximately 3.0 cm distal to the
greater tuberosity and just lateral to the bicipital groove.
Secure the plate to the humeral shaft using a 3.8 mm
multidirectional cortical screw through the oblong hole
of the plate.
While maintaining the reduction, place a 2.0 mm guide
wire through the central hole at the head of the plate.
Advance slowly and verify its trajectory under fluoroscopic
imaging until it reaches 2-3 mm below the
subchondral bone.
Using the short 4.0 mm drill bit, drill under power
through the F.A.S.T. Guides across the near cortex
until the mechanical safety stop of the drill is reached.
Manually advance the appropriate 4.0 mm long drill bit
through the F.A.S.T. Guides under fluoroscopic imaging
until 2-3 mm below the subchondral bone.
Be sure to torque the proximal plate pegs so that they
are fully seated. The head of a properly seated peg
should sit beneath the surface of the plate.
Using the end of the drill guide labeled “90°”, drill the
remaining shaft screws. Then use a locking setscrew
with each 90° locking shaft screw.
Repair the tuberosities to the plate through the side
loading suture attachment points.
Evaluate the humerus under fluoroscopy to assess the
final reduction and to confirm proper peg positioning.
3

Peg and Screw Options:
Item
STP Series,
Smooth Peg, Locking
STPT Series,
Threaded Peg, Locking
NL-SS Series,
90° Locking Setscrew
NL Series,
90° Cortical Screws,
Non-locking
MD Series,
Multi-directional Cortical
Screws, Non-locking
Description
Provides spatial subchondral support
Helps capture and
lag the humeral head
Secures the 90° lock distal screws
to the S3 Proximal Humerus Plate
Provide bi-cortical fixation while locking to the
plate using the NL-SS setscrews
Provide multi-directional fixation when used
through the oblong hole
S 3 Modular Tray:
New fully modular tray system that
offers intra-operative flexibility.
• Multiple Applications
• Reduced OR Clutter
• Improved Workflow
Plate Options:
Item Description
Head
Width
Shaft
Width
Overall
Length
S3 Proximal Humerus Plate, 3 Hole 16 mm 12 mm 71 mm
S3 Proximal Humerus Plate, 4 Hole 16 mm 12 mm 84 mm
S3 Proximal Humerus Plate, 6 Hole 16 mm 12 mm 109 mm
S3 Proximal Humerus Plate, 8 Hole 16 mm 12 mm 150 mm
S3 Proximal Humerus Plate, 11 Hole 16 mm 12 mm 195 mm
S3 Proximal Humerus Plate, 14 Hole 16 mm 12 mm 246 mm
Important:
This Essential Product Information sheet does not include all of the information necessary for selection and use of a
device. Please see full labeling for all necessary information.
Indications:
The S 3 Shoulder Fixation System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the
proximal humerus.
Contraindications:
If any of the following are suspected, tests are to be performed prior to implantation. Active or latent
infection. Sepsis. Insufficient quantity or quality of bone and/or soft tissue. Material sensitivity. Patients who are unwilling
or incapable of following post operative care instructions.
Warnings and Precautions:
• Although the surgeon is the learned intermediary between the company and the patient, the important information
conveyed in this document should be conveyed to the patient. The patient must be cautioned about the use, limitations
and possible adverse effects of these implants. The patient must be warned that failure to follow postoperative
care instructions may cause the implant or treatment to fail.
• An implant must never be reused. Previous stresses may have created imperfections that can potentially lead
to device failure. Protect implant appliances against scratching or nicking. Such stress concentration can lead to
failure.
• Orthopaedic instrumentation do not have an indefinite functional life. All re-usable instruments are subjected to
repeated stresses related to bone contact, impaction, routine cleaning and sterilization processes. Instruments
should be carefully inspected before each use to ensure that they are fully functional. Scratches or dents can result
Essential Product Information
in breakage. Dullness of cutting edges can result in poor functionality. Damaged instruments should be replaced to
prevent potential patient injury such as metal fragments into the surgical site. Care should be taken to remove any
debris, tissue or bone fragments that may collect on the instrument. Most instrument systems include inserts/trays
and a container(s). Many instruments are intended for use with a specific implant system. It is essential that the
surgeon and operating theatre staff are fully conversant with the appropriate surgical technique for the instruments
and associated implant, if any.
• Use fluoroscopy to prevent unintentional penetration of subchondral bone.
• The distal end of the pegs should be 3-6 mm below the subchondral plate. Readjust as necessary.
• Do NOT use unicortical screws (SNUS) with the shoulder plates. Use the SNUS with the SNP and the MD and NL
series multi-directional and locking screws with the shoulder plates.
• Ensure removal of all F.A.S.T. Guides after use.
• Do NOT permanently implant K-wires through the holes of the plate as they may back out and cause tissue damage.
Use of the K-wires allows you to provisionally secure the plates to the anatomy.
• Supply a sufficient amount of torque to the pegs to ensure that each is fully seated. If not seated properly, remove,
re-drill and reinsert the peg until fully seated. The head of the peg should sit beneath the surface of the plate to
avoid soft tissue irritation.
Adverse Effects:
• The following are possible adverse effects of these implants: potential for these devices failing as a result of
loose fixation and/or loosening, stress, excessive activity, load bearing particularly when the implants experience
increased loads due to a delayed union, nonunion, or incomplete healing. Failure to follow postoperative care
instructions may cause the implant or treatment to fail.
All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless
otherwise indicated.
For product information, including indications, contraindications, warnings, precautions
and potential adverse effects, see the product labeling.
This material is intended for the sole use and benefit of the Biomet sales force and
physicians. It is not to be redistributed, duplicated or disclosed without the express
written consent of Biomet.
P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 x 1501
©2012 Biomet Orthopedics • biomet.com
Form No. BMET0019.0 • REV053112