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BIOMET MICROFIXATION PECTUS Support Bar System 01-50-1049 Warnings and Precautions

Revision Rev E

BIOMET MICROFIXATION PECTUS Support Bar System

4 Pages

0086  1520 Tradeport Drive Jacksonville, Florida 32218 904-741-4400FAX 904-741-4500  01-50-1049 Revision: E Date: 2012/08  WARNINGS AND PRECAUTIONS FOR PECTUS SUPPORT BAR SYSTEM ATTENTION OPERATING SURGEON DESCRIPTION The Biomet Microfixation Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity... he 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... he device should be removed when remodeling is evident... ATERIALS The Pectus Support Bar and stabilizers are made from Stainless Steel or Titanium... NDICATION Pectus Excavatum and other sternal deformities... ONTRAINDICATIONS 1... atients with mental or neurological conditions who are unwilling or incapable of following instructions... atients presenting metal sensitivity reactions... atients with insufficient quantity or quality of bone or fibrous tissue to allow remodeling... nfection 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... he device is not intended to replace chest wall structures... hile 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... he surgeon is to be thoroughly familiar with the implants and the surgical procedure prior to surgery... he correct selection and placement of the implant is important... reoperative planning to determine the most appropriate size and final position of the implant is required... he surgeon should avoid sharp bends, reverse bends, or bending the device at a hole... he 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... ven 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... f the deformity is not partially eliminated, a secondary Pectus Support Bar may be required or an alternative method of treatment is to be considered... uring 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... hen considering removal, the surgeon should weigh the risks verses benefits when deciding when to remove the implant... here evidence of adequate remolding is present, removal should be performed... mplant removal is to be followed by post operative monitoring to check for reoccurrence of the deformity... here reoccurrence is encountered, a secondary treatment or alternative treatment may be necessary...  Do not reuse implants... hile an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant... o not treat patients with implants that have been even momentarily placed in a different patient... ATIENT WARNINGS Post operative care and monitoring is important... etallic fixation devices cannot withstand activity levels and loads equal to those placed on a normal healthy chest wall... he implant can loosen, migrate, bend, or break as a result of weight bearing, load bearing, strenuous activity, or traumatic injury... he patient is to be warned by the operating surgeon to limit activities accordingly... imitation 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... he patient must be made aware and warned that the deformity or some degree of deformity may be present even after treatment... n addition, the patient is to be warned of general surgical risks and possible adverse effects as listed, prior to surgery... OSSIBLE ADVERSE EFFECTS 1... etal sensitivity reactions or allergic reaction to the implant material... ain, discomfort, or abnormal sensation due to the presence of the device... urgical trauma; permanent or temporary nerve damage, permanent or temporary damage to heart, lungs, and other organs, body structures or tissues... kin irritation, infection, and pneumothorax... racture, breakage, migration, or loosening of the implant... nadequate or incomplete remodeling of the deformity or return of deformity, prior to or after removal of implant... ermanent injury or death... LEANING Prior to sterilization, all implants must be carefully cleaned and inspected... t 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... mplants in the tray which have touched the defect or entered the operative site, should be discarded... leaning should be performed by trained medical personnel... or additional cleaning information, contact Biomet Microfixation Regulatory Affairs department fax 904-741-9425... TERILITY Steam sterilize the Pectus Support Bar prior to implantation using steam sterilization equipment which has been properly validated... ollowing is a recommended minimum cycle for steam sterilization that has been validated by Biomet Microfixation under laboratory conditions... ndividual users must validate the cleaning and autoclaving procedures used on-site, including the on-site validation of recommended minimum cycle parameters described below... re-vacuumed Steam Sterilization (Hi-VAC) Wrapped: Temperature: 270 o Fahrenheit (132o Celsius) Time: 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... esting should be conducted in the health care facility to assure that conditions essential to sterilization can be achieved... ince 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...
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biomet_microfixation_pectus_support_bar_system_01-5.pdf

Page 1

0086

1520 Tradeport Drive

Jacksonville, Florida 32218

904-741-4400 . FAX 904-741-4500

01-50-1049

Revision: E

Date: 2012/08

WARNINGS AND PRECAUTIONS FOR

PECTUS SUPPORT BAR SYSTEM

ATTENTION OPERATING SURGEON

DESCRIPTION

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.

MATERIALS

The Pectus Support Bar and stabilizers are made from Stainless Steel or Titanium.

INDICATION

Pectus Excavatum and other sternal deformities.

CONTRAINDICATIONS

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.

4. Infection

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.

Page 2

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.

PATIENT WARNINGS

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

implant.

7. Permanent injury or death.

CLEANING

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.

STERILITY

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:

Temperature:

270 o Fahrenheit (132o Celsius)

Time:

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.

Page 3

MRI Information

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.

MRI-Related Heating

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

MRI Condition

+2.5C

1.5-T/64-MHz



+3.7 C

3-T/128-MHz

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.

Artifact Information

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:

Pulse Sequence

T1-SE

T1-SE

GRE

GRE

Signal Vold Size

34,454-MM2

20,670-mm2

54,785-mm2

17,877-mm2

Imaging Plane

Parallel

Perpendicular

Parallel

Perpendicular

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

Page 4

Fax:

European Sales Headquarters:

(+44) 1656 645454

Biomet Microfixation Europe

Toermalijnring 600

3316 LC Dordrecht

Netherlands

Phone: (+31) 78 629 29 10

Fax:

(+31) 78 629 29 12

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