INSTRUCTIONS FOR USE
OsteoBridge
™
Knee Arthrodesis Nail cemented
PTI0040-1012
1. General Information
Prior to using Merete products, the operating surgeon and assisting personnel
must thoroughly study the precautions and safety instructions specified in this
product information as well as the product-specific information (manual, brochure
etc.). The respective documents are provided by Merete. Likewise, the operating
surgeon must know the remaining risk of the product he intends to use and inform
the patient in advance accordingly. Only specifically qualified surgeons who have
profound knowledge and expertise in the field of bone and joint surgery and who
have proven this capability accordingly may perform the implantation. The
operating surgeon is responsible for any negative effects or complications that can
arise from faulty indications or surgical techniques, false implant selection and
handling and non-observance of the precautions and safety instructions in these
instructions for use. In such cases neither the manufacturer nor the authorized
representative of Merete products can be made liable.
2. Basic Principals
2.1. Description
OsteoBridge™ Knee Arthrodesis is used for the fixation of the knee joint. The
system is modular and consists of two cylindrical half-shells which form the
resection element, the spacer. The spacer is attached by means of 8 screws to two
intramedullary nails. Spacers and nails are available in different sizes to adapt to
the size of bone and defect. The nails are inserted into the bone using bone
cement. The system consists of an angled spacer for bridging the defect and
additional spacers with an outer diameter of 40 mm in lengths of 40 mm, 50 mm,
60 mm and 70 mm that can be connected with a spacer connector.
2.2. Characteristics
All implants are individual parts of a system. Hence the operating surgeon has a
special obligation of operative care in regard to compatibility of the individual parts
among each other and their application. Combinations are only permitted for
Merete products which are part of the system. The implantation must be performed
with the corresponding Merete instruments. The use of Merete instruments for
other than the intended purposes is not permitted. The reuse of explanted
components is not permitted under any circumstances. Resterilization of sterile
delivered products is also prohibited. The single parts of the OsteoBridge™ System
are joined together via secure clamping connections. This is only possible when
the assembled parts correspond exactly. All possible combinations are listed in the
products handbook and brochure. An interaction with drugs is not known.
2.3. General information on Implants
• The implantation of OsteoBridge™ should only be considered if this system
represents the best solution compared to other possible surgical alternatives.
• The treatment of a severely altered, diseased joint or bone by an implant can
reduce pain, allow load bearing and improve the patient’s mobility.
• Even a stable embedded implant may be subject to loosening in the long term
due to different reasons, making revision surgery necessary. The lifespan of the
OsteoBridge™ System is 10-15 years.
2.4. Indications
• Conditions resulting from previous operations such as joint reconstruction
(osteotomy), arthrodesis or knee prosthesis,
• posttraumatic condition preventing an implantation of a knee prosthesis,
• loosening or impairment of the pulley,
• neuromuscular indications,
• infections, which require immediate weight bearing of the extremity and
• tumours in the region of the knee.
2.5. Contraindications
• Acute or chronic infections, local or systemic,
• severe muscle, nerve or vascular diseases, which would endanger the affected
extremities,
• defective bone structures which would impede adequate anchoring of the implant,
• all accompanying diseases which could endanger the function and success of the
implant and
• patients with mental or neurological disease conditions or patients who are not
capable of following the necessary postoperative treatment instructions.
2.6. Factors Interfering with Success
• Allergies to implanted materials as well as to bone cement,
• degenerative bone diseases,
• adiposity or overweight of the patient,
• systematic disease and metabolic disturbances,
• alcohol and drug abuse and
• physical activity associated with strong shocks, in which the implant is exposed to
blows and/ or excessive strain.
2.7. Possible Effects
The most common adverse effects after an implantation are:
• Loosening of the implant resulting from changed conditions of the load transfer or
abrasion and fracture of the cement bed and/ or tissue reaction of the implant and
the associated abrasion products,
• early and late infection,
• undesired shortening or lengthening of the relevant extremity due to non-optimal
positioning of the implant,
• bone fractures resulting from unilateral-stress or weakened bone substance,
• reduction of bone density as a result of stress shielding or bone resorption as
tissue reaction to abrasion articles,
• temporary or permanent nerve damage as a result of pressure or hematoma,
• wound hematoma and delayed wound healing,
• vascular disease including venal thrombosis, pulmonary embolism and cardiac
arrest,
• heterotopic ossification,
• nerve damage due to surgical trauma. MRI examinations show no hazard for the
patients as the implant material is nonferromagnetic.
In examinations with MRI material artifacts are possible.
2.8. Changes in the performance of the Implants
Severe morphological changes of the supporting bone structure or abrasion of the
moving parts can change the performance of the implant. In extremely rare cases,
especially with trauma or overstraining, this may lead to failure of a component. In
any case the patient should be informed and should take precautionary measures
to reduce the mechanical strain on the implant.
3. Instructions for Use
3.1. Pre-operative Planning
The planning of the surgery must take place on the basis of detailed evaluations of
the patient’s x-rays, which supply the necessary information for the selection of the
implant type and size and possible combinations. X-ray templates for pre-operative
planning are available from Merete on request. Pre-operative tests for allergic
reactions of the patient to the implant material are recommended. During the
surgery trial components should be used to check the correct position and size. All
sizes of the planned implants must be available. Prior to inserting the implant, do
not fail to check the marking (type, item number, material and size) with the labels
on the packaging. The enclosed labels have to be used for the surgical protocol
and the patient implant pass as well as for reordering.
Important:
Before implantation please check the validity of the expiration date.
3.2.Handling of the Implants
Please note:
• During the implantation the operating surgeon should pay attention that the
surfaces of the implant are not damaged due to nicks and scratches. Even a slight
scratch can considerably reduce the lifespan of an implant.
• The implantation must be performed with the corresponding Merete instruments.
The use of Merete instruments for other than the intended purposes is not
permitted. The reuse of explanted components is not permitted under any
circumstances.
• It is essential to ensure that the nails of the implants are clamped into
the spacer according to their respective minimal clamping length.
• Also the instructions for the assembling of the spacer with the spacer
screws are to be followed exactly. Screws must be tightened with the
required torque in the given order. The spacer half-shells have to be
aligned parallel.
• Prior to assembling the spacer wash the clamping surface in order to
completely remove all kinds of debris, including bone splinters, soft
tissue parts, bone cement and others.
• When using bone cement:
◦◦ Pay attention to the information given by the cement manufacturer,
◦◦ the cement bed should be spread evenly.
3.3. Revision Surgery
If all components of the implant have to be replaced, the same handling
instructions as in the initial surgery apply to the new components. Partial
replacement of implant components lead to mixing of used and possibly
damaged parts with new components. If only a few implant components
have to be replaced the interface of those components has to be in
proper condition. We always recommend a complete exchange of all
components.
4. Further Informations for use
4.1. Cleaning instructions for reusable surgical instruments and
non-sterile implants
• Cleaning
• Disinfection
• Sterilization with hot steam (DIN EN ISO 17665-1)
Warnings
Instruments / implants that are supplied non-sterile are clearly marked
with “NON STERILE” and must be cleaned, disinfected and sterilized
prior to their use. The instruments / implants may only be processed by
qualified personnel. Only approved cleaning agents and disinfectants
(RKI, DGHM/VHA, FDA) are to be used (pH < 12 pH < 12 for instruments
/ implants made of metal). Instruments / implants made from synthetic
materials or containing components made from synthetic materials may
by no means be sterilized using dry heat.
At the place of use
• Instruments / implants should be reprocessed as soon as possible after
their use.
• Remove surface contamination with a disposable towel / paper towel
• To reduce the risk of infection for the user and to facilitate cleaning, the
instruments / implants should be submerged in disinfectant solution or hot
water (80°C) immediately after use.
Preparation for cleaning
Dismantle detachable instruments / implants
Automatic cleaning and disinfection
• If possible, the instruments / implants should be cleaned mechanically
as opposed to being cleaned by hand.
• The cleaning device should offer a suitable program for thermal
disinfection. A0 value > 3000, or if using an older device at least 10 min.
at 93°C. If using chemical disinfection, the risk of residues on the
instruments / implants must be considered.
• When choosing the cleaning agent, the compatibility with the material of
the instrument / implant must be verified.
• When loading the device, the manufacturer‘s instructions are to be
followed. The instruments / implants are to be positioned in such a way,
that channels and cavities can be rinsed thoroughly and completely.
• The final rinsing is to be carried out with demineralised water.
• A sufficient drying phase is to be kept.
• Remove instruments / implants from the machine immediately after the
end of the program and dry with an absorbent, soft, lint-free towel if
necessary.
Manual cleaning
• First, rinse instrument / implant under clean running water or detergent
and remove debris from the surface using a soft bristle brush or lint-free
towel. Do not use abrasive cleaners or metal brushes.
• Submerge instrument / implant in detergent under observance of the
manufacturer‘s instructions for the detergents concentration and
exposure time as well as compatibility with the material of the
instrument/implant.
• Ensure that the instrument/implant is completely covered by the
detergent. Be sure tovent all cavities, lumens and openings. Use a
suitable brush to clean lumens and holes.
• After cleaning, rinse with demineralized water and dry sufficiently.
• Ultrasonic cleaning follows.
• Ensure that the ultrasonic bath is preheated as specified by the device
manufacturer or the manufacturer of the cleaning solution.
• Ensure that all instruments / implants in the ultrasonic bath are covered
by the cleaning solution and all cavities, lumens and openings are
completely vented.
• The instruments / implants are to be cleaned for 5 minutes at
35 - 40 kHz.
• After ultrasonic cleaning, rinse instruments / implants under clean
running water, making sure to also rinse cavities, lumens and holes
where necessary.
Maintenance of instruments
• Allow instruments / implants to cool down to room temperature.
• Slightly lubricate movable parts with sterilizable, steam-permeable
surgical oil.
Control and functional test
• After each cleaning / disinfection, ensure that the instruments / implants
are clean and functional, i.e. checking for any damaged, bent, broken or
worn parts.
• Damaged instruments / implants are to be removed and may not be
reused.
Packing
Prior to steam sterilization, the cleaned and disinfected
instruments/implants should be packed in suitable containers or suitable
sterilization-pouches (DIN EN ISO 11607).
Sterilization
• Instruments / implants are to be sterilized using a method validated in
accordance with EN ISO 17665. We recommend steam sterilization using
a fractionated vacuum procedure.
• The maximum sterilization temperature is 134°C (273°F) plus tolerance
according to EN ISO 17665-1.
• Sterilization time (exposure time at sterilization temperature) should be
at least 20 min at 121°C (250°F) or 5 min at 134°C (273°F).
• The recommended pressure is 3 bars.
Storage
After sterilization, the instruments / implants are to be stored dry and
dust free in their sterilization packaging.
Processing information in accordance with EN ISO 17664:2004
It is the responsibility of the operator to ensure that the carried out processing
achieves the desired result with the apparatus, materials and personnel used in the
sterilization facility. This usually requires validation and routine monitoring of the
process. Likewise, any deviations from the provided instructions should be carefully
evaluated by the operator for their effectiveness and possible adverse
consequences. Furthermore, we point out that it is important to consider the
recommendations of the Robert Koch Institute published in the
Bundesgesundheitsblatt (Federal Health Bulletin) 4 2006 and any other national
regulations relating to processing of instruments/implants.
4.2. Sterile Implants
Implants which are delivered in sterile condition are clearly labeled “STERILE”.
Sterile implants have been sterilized with 25 to 42 kGy (2.5 to 4.2 Mrad) gamma
rays. All sterile implants are to be stored unopened in the original packing,
protected from light, dry, in room temperature or cool, however frost-free. Before
using the implants, the sterilization expiration date should be noted and the
protective packaging checked for damage. The red sterilization-point indicates a
sterile product. Products with a damaged packaging may not be used. Aseptic
procedures should be observed when removing the implants.
4.3. Resterilization
Resterilization of polyethylene components is not allowed. All implants (metal or
ceramic) in original packaging can be resterilized by Merete for a fee. Any liability
for implants resterilized by the purchaser is excluded.
4.4. Reusable instruments
Careful handling is required for long-lasting functional capability.If not stated
otherwise by the distributor the instruments can be used for an indefinite length of
time, as long as their functionality is given. Upon request Merete will send detailed
instructions for cleaning. The instruments must be handled according to RKI
(Robert Koch Institute) guidelines and the German Medical Products Ordinance
PVertreibV).
4.5. Storage and handling of implants
OsteoBridge™ implants must be stored in the original packaging in a dry, clean
place at a temperature ranging from room temperature to cool but above freezing.
Prior to using the implant, the sterilization expiration date on the product label has
to be checked and the protective packaging inspected for any damage. If the
packaging is damaged the implants must not be used. When removing the implant
from the protective packaging, the rules of asepsis have to be followed.
OsteoBridge™ implants must be handled with extreme care, since even minimal
damage of the surfaces can lead to a failure of the implant. Therefore even the
subsequent marking of prostheses surfaces or touching them with metal or other
hard objects (e.g. instruments) must be avoided. The mechanical processing and
modification of medical components leads to a loss of authorization and is not
permitted. Implants that were handled in an improper way or exhibit damage (e.g.
scratches) must not be implanted. See also 4.2 Sterile Implants.
4.6. Patient information
The patient must be informed by the doctor regarding the information provided in
section 2, i.e. to factors which could interfere with the success of a surgery as well
as possible complications which could result from such an indication. The patient
must be informed about which measures he can take to reduce the possible effects
of these factors. All information given to the patient must be documented by the
operating surgeon in writing.
4.7. Materials of the implants
The implant must be inserted using bone cement (PMMA) according to the
specifications supplied by the manufacturer. All metal components are made of
the following material:
• TiAl6V4 ELI alloy (ASTM F 136, ISO 5832-3)
Further information about the chemical composition and the mechanical properties
of the used materials can be requested from Merete.
WARRANTY:
This product is warranted to be free from defects in material and workmanship.
SYMBOLS USED ON LABELING:
4828
CE-mark
Sterilized using irradiation
Batch code
Catalog number
Caution, consult
accompanying documents
Consult instructions for use
Do not reuse
Keep dry
Date of manufacture
Use by YYYY-MM
Manufacturer
Quantity
Information
Please contact us for further information.
Manufacturer
Merete Medical GmbH
Alt-Lankwitz 102
12247 Berlin / Germany
Tel.: +49 / (030) / 77 99 80-0
Fax: +49 / (030) / 76 68 03 61
E-Mail: [email protected]
www.merete-medical.com
QTY
1
