1520 Tradeport Drive
Jacksonville, Florida 32218
904-741-4400 . FAX 904-741-4500
WARNINGS AND PRECAUTIONS FOR
PECTUS SUPPORT BAR SYSTEM
ATTENTION OPERATING SURGEON
The Biomet Microfixation Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of
Pectus Excavatum deformity. The Pectus Support Bar provides the surgeon with a means to reposition bony
structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity.
The device should be removed when remodeling is evident.
The Pectus Support Bar and stabilizers are made from Stainless Steel or Titanium.
Pectus Excavatum and other sternal deformities.
1. Patients with mental or neurological conditions who are unwilling or incapable of following instructions.
2. Patients presenting metal sensitivity reactions.
3. Patients with insufficient quantity or quality of bone or fibrous tissue to allow remodeling.
WARNINGS AND PRECAUTIONS
The Pectus Support Bar provides the surgeon with a means of treating Pectus Excavatum, funnel chest, a
congenital deformity often accompanied by shortness of breath in children. The device is not intended to replace
chest wall structures. While the device is intended to expand the chest wall cavity eliminating the features of the
deformity, the degree of initial reshaping and permanent remodeling for each case cannot be predetermined.
The surgeon is to be thoroughly familiar with the implants and the surgical procedure prior to surgery. The
correct selection and placement of the implant is important. Preoperative planning to determine the most
appropriate size and final position of the implant is required. The surgeon should avoid sharp bends, reverse
bends, or bending the device at a hole. The implant can become dislodged, shift, or flip as a result of improper
device selection, improper stabilization, not suturing the device(s), or patient activity too soon after surgery.
Even though the implant is mechanically fixed (sutured) in position, care is to be taken to assure that the device
is rigidly in apposition to the area of the deformity, as demonstrated by total or partial elimination of the visible
deformity. If the deformity is not partially eliminated, a secondary Pectus Support Bar may be required or an
alternative method of treatment is to be considered. During the course of the surgical procedure, and during
implantation, extreme care is to be taken to avoid contact with the heart and lungs with either the implant or
instruments, as contact to these organs can cause death or permanent injury to the patient. When considering
removal, the surgeon should weigh the risks verses benefits when deciding when to remove the implant. Where
evidence of adequate remolding is present, removal should be performed. Implant removal is to be followed by
post operative monitoring to check for reoccurrence of the deformity. Where reoccurrence is encountered, a
secondary treatment or alternative treatment may be necessary.
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.
Post operative care and monitoring is important. Metallic fixation devices cannot withstand activity levels and
loads equal to those placed on a normal healthy chest wall. The implant can loosen, migrate, bend, or break as a
result of weight bearing, load bearing, strenuous activity, or traumatic injury. The patient is to be warned by the
operating surgeon to limit activities accordingly. Limitation of physical activities may be unique to each patient
and the patient should be warned that noncompliance with post operative instructions could lead to
complications described above. The patient must be made aware and warned that the deformity or some degree
of deformity may be present even after treatment. In addition, the patient is to be warned of general surgical
risks and possible adverse effects as listed, prior to surgery.
POSSIBLE ADVERSE EFFECTS
1. Metal sensitivity reactions or allergic reaction to the implant material.
2. Pain, discomfort, or abnormal sensation due to the presence of the device.
3. Surgical trauma; permanent or temporary nerve damage, permanent or temporary damage to heart, lungs, and
other organs, body structures or tissues.
4. Skin irritation, infection, and pneumothorax.
5. Fracture, breakage, migration, or loosening of the implant.
6. Inadequate or incomplete remodeling of the deformity or return of deformity, prior to or after removal of
7. Permanent injury or death.
Prior to sterilization, all implants must be carefully cleaned and inspected. It is important to confirm that
implants which are returned for processing from the operating room have not entered the operative site, as they
may have been compromised. Implants in the tray which have touched the defect or entered the operative site,
should be discarded. Cleaning should be performed by trained medical personnel. For additional cleaning
information, contact Biomet Microfixation Regulatory Affairs department fax 904-741-9425.
Steam sterilize the Pectus Support Bar prior to implantation using steam sterilization equipment which has been
properly validated. Following is a recommended minimum cycle for steam sterilization that has been validated
by Biomet Microfixation under laboratory conditions. Individual users must validate the cleaning and
autoclaving procedures used on-site, including the on-site validation of recommended minimum cycle
parameters described below.
Pre-vacuumed Steam Sterilization (Hi-VAC) Wrapped:
270 o Fahrenheit (132o Celsius)
Four (4) minutes
Drying Time: Thirty (30) minutes MINIMUM
Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material,
including a reusable rigid container system, is suitable for use in sterilization processing and sterility
maintenance in a particular health care facility. Testing should be conducted in the health care facility to assure
that conditions essential to sterilization can be achieved. Since Biomet Microfixation is not familiar with
individual hospital handling methods, cleaning methods and bioburden, Biomet Microfixation cannot assume
responsibility for sterility even though the guideline is followed.
The Pectus Bar Implant, Part #01-3717 is MR-conditional according to the terminology specified in the American Society
for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices
and Other Items for Safety in the Magnetic Resonance environment. ASTM International, 100 Barr Harbor Drive, P.O.
Box C700, West Conshohocken, Pennsylvania, 2005.
Non-clinical testing demonstrated that the Pectus Bar Implant, Part#01-3717 is MR-Conditional. A patient with this
implant can be scanned safely immediately after placement under the following conditions:
Magnetic Field Interactions
• Static magnetic field of 3-Tesla or less
• Maximum spatial gradient magnetic field of 720-Gauss/cm or less.
In non-clinical testing, the Pectus Bar Implant, Part #01-3717 produced the following temperature rises during MRI
performed for 15-min in 1.5-Tesla (1.5-Tesla/64MHz, Magnetom, Siemens Medical Solutions, Malvern, PA. Software
Numaris/4, Version Syngo MR2002B DHHS) and 3-Tesla (3-Telsa/128-MHz, Excite, Software G3.0-052B, General
Electric Healthcare, Milwaukee, WI) MR systems, as follows:
Highest Temperature Change
Therefore, the MRI-related heating experiments for the Pectus Bar Implant, Part#01-3717 at 1.5-Tesla and 3-Tesla using a
transmit/receive RF body coil at MR system reported whole body averaged SARs of 2.4-W/kg (i.e., associated with a
calorimetry value of 2.0-W/kg) and 2.5-W/kg (ie., associated with a calorimetry value of 2.2-W/kg), respectively, indicated
that the greatest amount of heating that occurred in association with these specific conditions was equal to or less than 2.5º
C at 1.5-Tesla and 3.7º C at 3-Tesla.
MR image quality may be compromised if the area of interest is in the same area or relatively close to
the position of the Pectus Bar Implant, Part #01-3717. The artifact size information is, as follows:
Signal Vold Size
Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.
Operating Surgeons and all personnel involved with handling these products are responsible for attaining
appropriate education and training within the scope of the activities with which they are involved in the
handling and use of this product.
Authorized Representative in EC: Biomet UK, Ltd.
Waterton Industrial Estates,
Bridgend, South Wales
CF31 3XA, U.K.
Phone: (+44) 1656 655221
European Sales Headquarters:
(+44) 1656 645454
Biomet Microfixation Europe
3316 LC Dordrecht
Phone: (+31) 78 629 29 10
(+31) 78 629 29 12