Integra LifeSciences Kirschner Wires - Manual

Integra
®
Miltex
®
Kirschner Wires
Directions for Use
The Kirschner wire is provided non sterile.
Please review sterilization instructions prior to use.
Indications
Orthopedic fixation pins and wires are intended to perform as fixation and
stabilization units of bone fractures or as guidance at insertion of implants into
the skeletal system.
Contraindications
Do not use the implant in cases of:
• States of health, which exclude adequate assistance or healing process:
• Impairment of blood supply
• Inadequate quantity and/or quality of bone structure
• Extreme adiposis
• Previous infection
• Strong twist or disposition of shank
• Mental conditions which exclude participation in rehabilitation programs
(Parkinson’s, alcohol or drug abuse, etc.).
• Major physical activities, adherent with intense percussion, on which
the implants are exposed to excessive pressure.
• Allergic reactions against components.
The pins and wires have not been evaluated for safety and compatibility in
the Magnetic Resonance (MR) environment. The pins and wires have not been
tested for heating or migration in the MR environment. Do not use the pins and
wire in a MR environment.
Warnings
• The device may only be resterilized if it has not been in contact with
bodily fluids.
• Do not use or process damaged or defective instruments. Contact your
local representative or dealer for repair or replacement.
• The use of an instrument for tasks other than those for which they
are intended may result in damage/broken instruments and/or patient injury.
• Do not use implants if the packaging is damaged.
• Do not use if sterility has been compromised.
Precautions
• Prior to use, thoroughly read these directions for use and become
familiar with the surgical technique.
• Keep the directions for use accessible to all staff.
• The operating surgeon must have a thorough command of both the
hands-on and conceptual aspects of the established operating techniques.
• Proper surgical performance of the implantation is the responsibility of
the operating surgeon.
• The manufacturer is not responsible for any complications arising from
incorrect diagnosis, choice of incorrect implant, incorrect operating
techniques, the limitations of treatment methods or inadequate asepsis.
• Under no circumstances should modular implant components from
different suppliers be combined.
• Each patient’s record must document the implant used including the
name, article number and lot number.
• During the postoperative phase, in addition to mobility and muscle
training, it is of particular importance that the physician keeps the
patient well informed about post-surgical behavioral requirements.
• Damage to the weight-bearing structure can give rise to loosening,
dislocation and migration as well as other complications. To ensure earliest
possible detection of such catalysts of implant dysfunction, the implant
must be checked periodically post-operative using appropriate techniques.
• Do not reuse an implant. Although the implant may appear undamaged,
previous stresses may have created non-visible damage which could result
in implant failure.
• Do not use an implant if the packaging is damaged. An implant with
damaged packaging may be damaged and should not be sterilized
and/or used.
• Do not resterilize implants which have been contaminated by
blood or secretions.
Adverse Reactions
Adverse reactions may include:
• Clinical failure (pain or injury) due to bending, loosening, wear and
tear, fracture of implant, loss of fixation, dislocation and/or migration
• Pain and/or abnormal sensations due to the presence of the implant
• Primary and/or secondary infections
• Allergic reactions to implant material
• Injury to vessels, nerves and/or organs
• Hematoma and/or impaired wound healing; hemorrhage
Instructions
Preoperative
The operating surgeon creates an operation plan specifying and
documenting the following:
• Implant component(s) and their dimensions
• Proper position of the implant component(s)
The following must be fulfilled prior to application:
• All required implant component(s) are readily available.
• Highly aseptic operating conditions are present.
• All requisite implantation instruments are available and in
working order, including the trial.
The operating surgeon and operating room team must be thoroughly
familiar with the operating technique, as well as the range of implants and
instruments to be applied. Complete information on these subjects must be
readily available at the operating facility.
The operating procedure must be explained to the patient and the patient’s
understanding of the following information must be documented:
• The patient is aware of the risk associated with general surgery,
orthopedic surgery and with general anesthesia.
• The patient has been informed about the advantages of the implant
procedure and possible alternative treatments.
• The implant may fail due to excessive load, wear and tear, or infection.
• The service life of the implant is determined by body weight and
physical activity. The implant must not be subjected to overload through
extreme strain, or through work-related or athletic activities.
• Corrective surgery may be necessary if the implant fails.
• The patient must have his or her physician carry out follow-up
examinations of the implant at regular intervals.
Postoperative
• Reiterate preoperative instructions to the patient.
• Ensure that the patient is aware of physical activity restrictions and
possible adverse reactions.
Storage, Inspection, Cleaning & Sterilization Instructions:
The implant is individually packaged in protective packaging and is labeled
according to its contents. The implant is labeled “non-sterile” and must be
cleaned and sterilized prior to use.
• Store the implant in the original protective packaging.
• Do not remove the implant from the packaging until
immediately before use.
• Store the implant in normal hospital environmental conditions.
ENGLISH