Osteosynthesis Implants

Sterility ■ The implant components are supplied in an unsterile condition.

Aesculap® Osteosynthesis Implants

► Store the implant components in their original packaging and only remove them from their original and protec-

tive packaging immediately prior to application. ► Use the implant system storage devices for processing, sterilization and sterile setup. ► Ensure that the implant components in their implant system storage devices do not come into contact with each

other or with instruments. ► Ensure that the implant components are not damaged in any way.

Intended use The osteosynthesis implants, available in different geometries and sizes, are used for the temporary stabilization of the skeletal system to support normal healing processes. They comprise: ■ Bone plates ■ Bone screws ■ Plain washers ■ K-wires ■ Küntscher intramedullary nail ■ Hook-shaped intramedullary nails ■ Steinmann nails ■ Schanz screws ■ Bone wire ■ Ligature plates ■ Bone clamps

Materials ■ Implant steel according to ISO 5832-1

Indications Use for: ■ Fixation of bone fractures and fragments ■ Supportive function for the reconstruction of the bone anatomy ■ Corrective osteotomies ■ Arthrodeses

Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the following validated reprocessing procedure: Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Validated reprocessing procedure Mechanical alkaline cleaning and thermal disinfection ► Process the implant in its system storage device. ► Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots).

Machine type: single-chamber cleaning/disinfection device without ultrasound

Contraindications Do not use in the presence of: ■ Acute or chronic infection in the region of the implant fixation ■ Anticipated overloading of the implant ■ Foreign body sensitivity to the implant materials ■ Allergic reaction to implant material (e.g. metals) ■ Severe defects of the bone structures in the part of the skeletal system concerned, which cannot provide stable fixation of the implants ■ Dependency on pharmaceutical drugs, drug abuse, or alcoholism ■ Inadequate patient compliance ■ Medical or surgical conditions that could negatively affect the outcome of the implantation

Side effects and interactions ■ Change in position, loosening, and breakage of implant components ■ Delayed healing, or non-union and development of pseudarthrosis ■ Primary and secondary infections ■ Venous thrombosis, lung embolism, cardiac arrest ■ Tissue reaction to implant materials ■ Trauma to nerves, tendons, or vessels ■ Hematomas and wound healing disorders ■ Reduced joint mobility and flexibility ■ Arthralgia and reduced tolerance for exercise

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – < 5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

For implant components that are to be resterilized:

Safety notes CAUTION Federal law restricts this device to sale by, or on order of a physician! ■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly. ■ General risk factors associated with surgical procedures are not described in this documentation. ■ The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques. ■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood vessels, muscles, and tendons. ■ It is the operating surgeon's responsibility to ensure the correct combination of implant components and their implantation. ■ Aesculap is not responsible for any complications arising from erroneous indication, wrong choice of implant, incorrect combination of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis. ■ The user instructions for individual Aesculap implant components must be followed. ■ The implant components were tested and approved in combination with Aesculap components. If other combinations are used, the responsibility for such action lies with the operating surgeon. ■ Do not, under any circumstances, combine implant components from different manufacturers. ■ Do not, under any circumstances, use damaged or surgically excised components. ■ Implants that have been used before must not be reused. ■ The attending physician shall make any decision with regard to the removal of implant components that have been used, Interactions between MRI and implant components!

WARNING

WARNING

Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Handle the implants with new gloves only. ► Keep the implant system storage devices covered or closed. ► Process implant system storage devices separately from instrument trays. ► Clean implants must not be processed together with contaminated implants. ► Process the implant components individually and separately if no implant system storage devices are available, ensuring that the implant components are not damaged in the process. ► Mechanically clean and disinfect the implant components. ► Do not reuse surgically contaminated implants! Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood.

Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Immediately sort out damaged or inoperative products.

■ In case of long implants e.g. Küntscher intramedullary nails, MRI scans can induce a critical local heating effect.

■ Implants produce clear MRI artifacts. ■ MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an additional risk to implant wearers.

Packaging ► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Make sure that the packaging will prevent a recontamination of the product whilst in storage.

■ The implant components applied, along with their article numbers, the name of the implant, as well as the batch

Sterilization

number and serial number (if available) must be documented in all patient records. ■ Postoperatively, individual patient information, as well as mobility and muscle training, is of particular importance. ■ In order to promote the earliest possible detection of any problems or complications, the operation results must be followed up at regular intervals with the aid of appropriate examination procedures. A precise diagnosis requires x-rays taken in the directions anterior-posterior and medial-lateral.

► Validated sterilization process

– Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.