3.6.9 Introducing stoppers
A stopper is introduced to the hole in the proximal part of the nail. The length of the stopper is based by the
the nail as it is embedded (0 mm; 5 mm; 10 mm; 15 mm; 20 mm). The stopper should be flushed with the
outer cortex.
3.7 Final inspection of reposition, position and length of screws in the lateral, axial and Broden projection.
3.8 Completion of the operation
The wounds are rinsed with a sufficient quantity of physiological solution, or a Redon drainage catheter is
introduced. Closing the operating access point is performed in individual layers. The final step is application of
a sterile dressing, plaster splint or elastic bandage. The chosen variation depends on the decision of the treating
physician based on stability of fixation of the fracture and condition of soft tissue.
Post-operative care
The treating physician determines a rehabilitation plan based on results of the operation and consequent checkups.
It is recommended to commence rehabilitation immediately on the first day after operation or after removal of the
plaster splint. It is always necessary to respect the fact that the applied osteosynthetic material is only for fixation
and is not designed for receiving the full weight of the patient. Full weight is recommended only after creation of a
strong bony callus, so that the bone tissue that has grown over receives the full weight. If creation of a sufficiently
strong bony callus does not occur, it is not possible to allow full weight on the extremity due to the danger of
fixation failure and damage to the osteosynthetic material, and it is necessary to choose an osteosynthesis method
based on assessment by the treating physician.
Magnet therapy is recommended to accelerate healing.
Removing osteosynthetic material
1. It is recommended to extract the implants. All osteosynthetic material however can be left in the patient if
there are no reasons for its removal, such as infection, impingement syndrome, pain, etc.
2. Extraction procedure:
Loosen stopper.
Loosen fixation screws.
Nail extraction.
WaRninG
The aiming device arms are produced from an X-ray-transparent material. Sterilization
can be performed only by using steam at a max. temperature of 134 °C, overpressure of
304 kPa for a period of 10 minutes!
When applying higher temperatures, permanent deformation and loss of function of
the arms may occur!
When cleaning and disinfecting, it is necessary to avoid agents containing chloride ions, which may cause corrosion
of the steel parts.
Implants – different types of materials must not be combined
(steel-titanium) – incorrect
(titanium-titanium), (steel-steel) – correct
Products may not be combined with products of different manufacturers.
READ CAREFULLY!
Preventative measures:
1. The implant must never be used twice! Previous stress may decrease its fatigue limit, and if applied twice, it
may lead to failure of osteosynthesis.
2. The implant is only for fixation and may not receive the full weight of the patient. After healing and fixed
bone fusion, it is recommended to remove the implant. Extraction depends on the judgment of the physician
providing treatment.
3. The operator must be familiar with the surgical procedure while using prescribed instrumentation. Only a person
who has undergone instruction in accordance with this instruction manual may use these medical devices.
4. Only use the prescribed instrumentation for performing the operation.
5. Consider the appropriateness of using the implant in patients where it is not certain that they will cooperate
with the physician after the operation (ex. alcoholics, addicts, the mentally ill).
6. Protect the implant from deformation and scratching, when handling, avoid contact with other metal materials
and chemicals.
7. Do not use implants with a given patient that are different in terms of material, because contact of various
metals may accelerate the corrosion process, which may lead prematurely to a decrease in the effectiveness
and service life of the implant, as well as to an increased quantity of metallic compounds that are released in
the body of the patient and could evoke a toxic reaction.
8. Decide on the possible premature removal of the implant if you suspect poor healing of the bone or that it is
becoming loose, bending, or breaking in the bone, because this could lead to serious injury to the patient.
9. Decide on removing the implant for internal fixation while taking into account such factors as the risks for
patients in consequence of an additional surgical procedure, and difficulties during and after implant removal.
10. Patients who smoke or use products containing nicotine have increased frequency of the fractures failing to
heal. It is necessary to notify such patients of this fact, and warn them of possible consequences.
11. The appearance of implant failure is more probably amongst heavy, physically active persons.
12. The manufacturer bears no liability if the product is used in a manner other than as stated in the instruction
manual, or in the surgical procedure.
13. The manufacturer bears no liability if the product is used in combination with implants of other manufacturers.
Instructions to the patient:
1. Notify the patient that he or she must follow precisely the instructions of the treating physician.
2. Inform the patient on the course of the operation, on potential risks and on the rehabilitation program.
3. Instruct the patient when he or she can apply full body weight on the bone with internal fixation, in order to
prevent damage to the implant.
4. Instruct the patient to maintain a reasonable level of activity in order to keep from refracturing the calcaneus.
5. Inform the patient when probable removal of the implant is to occur.
6. Inform the patient to maintain a reasonable level of activity after implant removal, because refracturing could
occur before the bone completely heals over and before the bone cavity becomes full.
Possible side effects:
1. Poor fusion of fragments, suppressed revascularization and poor formation of bony callus may cause loosening,
bending or breaking of the implant or premature loss of solid bone fixation.
2. Early or late infection, both deep and superficial.
3. Avascular necrosis.
4. Damage to nerves and tendons as a result of the surgical procedure.
5. Allergy to Ni.
6. Development of arthrosis.
7. A risk of incorrect diagnosis when the diagnostic devices CT or MRI are used where the presence of steel implant
in the given locality causes a wrong image.
Serious complications may occur with every surgical operation when removing the results of multiple injuries. These
complications include urogenital, gastrointestinal and vascular disorders including thrombosis, bronchiopulmonary
disorders including embolism, myocardial infarct and death.
Limitation of repeated use:
The implants are designed for one-time use in humans. If the implants were
prepared for a surgical procedure and became contaminated, they may be prepared for use again through a process
of cleaning, disinfection and sterilization described hereunder.
insTRucTiOns
NOTICE:
The implant is supplied UNSTERILE. It is wrapped in polyethylene packaging. It is cleaned and disinfected by
the manufacturer. Prior to first use, remove the implant from the packaging and perform sterilization based on
the regulation. If the packaging is not fully intact, it is necessary to return the implant to the manufacturer for
repackaging.
Place of use:
Specialized facility for health-care providers, mainly surgical and orthopedic facilities.
Storage and transport:
Protect the implant from deformation and scratching, when handling, avoid contact
with other metal materials and chemicals.
Preparation for cleaning:
IMPLANTS
Implants are cleaned by the manufacturer, so it is not necessary to clean or disinfect them. If it becomes
necessary to disinfect an unused implant, it is necessary to use a disinfectant containing no chloride ions
and which is appropriate for use on steel instruments. Damage (scratching) of the implant must not occur
during disinfection.
INSTRUMENTATION
1. Remove the arms from the aiming device body.
2. Perform mechanical cleaning with water and brush.
3. Rinse the instruments with pressurized water.
4. Submerge the instruments in a disinfecting solution for 20 to 30 minutes. The recommended disinfection agent
is
Sekusept pulver, NeodisherseptoMED
. Danger of damaging instruments exists if a different solution is applied.
5. Rinse again with pressurized water until only clean water runs off. Rinsing may be performed in a conventionally
supplied pressurized washer for connecting instruments to the jets.
6. Blow dry the instruments with pressurized air.
Disinfection:
We recommend either a washing appliance and thermal or thermochemical disinfection, or hand
washing of the implants and instruments after chemical disinfection with an agent having virucidal effects, whereas
it is possible to join both stages by use of disinfecting agents with combined washing effect. It is possible to
use the disinfecting agent in accordance with the instructions listed on the label of this agent. When preparing
the disinfectant and washing solutions, you must uphold the procedure given by the manufacturer. Instruments
designed for disassembly are disassembled and each part is then considered to be separate. After performing
disinfection, the implants and instruments are rinsed with pure demineralized water to remove chemical residue
remaining on the implants and instruments.
Recommended agents:
Sekusept pulver, NeodisherseptoMED
Drying:
If drying is a part of a machine washing and disinfection cycle, the temperature may not exceed 120 °C.
Maintenance:
After performing each operation, it is necessary to check individual parts of the instrumentation.
It is also necessary to check cutting instruments for bluntness. In the event of damage, it is necessary to send the
parts to the manufacturer for performing repairs. After 10–20 performed operations, it is recommended to contact
the manufacturer for performing a service inspection.
Inspecting and testing function:
Prior to using the implant, it is necessary to visually inspect for completeness
and proper function.
Sterilization:
If not stated otherwise, sterilization is recommended with moist heat in a steam sterilizer equipped
with an antibacterial filter at a temperature of 121 °C, overpressure of 205 kPa for a period of 20 minutes or a
temperature of 134 °C, overpressure 304 kPa and for a period of 10 minutes.
Further information:
The company MEDIN, a.s., validated the above-mentioned procedures of cleaning,
disinfection, drying and sterilization. By this validation, these procedures have been recognized as qualified for
preparation of medical devices designed for repeated use.
The user is responsible for acquiring the necessary materials, equipment and training of employees in accordance
with these prescribed procedures, in order to achieve the required result.
The user may also apply other procedures, but the effectiveness of these alternative procedures must be verified
by a qualified laboratory.
Storage:
Store the packed products in a dry and clean environment without extreme temperatures and humidity,
out of the reach of direct sunlight.
Liquidation of the implant:
The implant is considered hazardous waste after use. The user is responsible for
performing measures assuring safe handling and liquidation of the product.
After drying, used implants are discarded and put aside as potentially hazardous waste.
Manufacturer: CZ43378030
MEDIN, a.s. | Vlachovická 619 | CZ 592 31 Nové Město na Moravě | Czech Republic
tel.: +420 566 684 336 | fax: +420 566 684 385 | e-mail: [email protected]
Number and date of last revision: R01/2015-03-24
