Johnson & Johnson DePuy Synthes Mitek Tibial Guide, Manual

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DePuy Mitek Tibial Guide System
Rx Only
DEVICE DESCRIPTION
The DePuy Mitek Tibial Guide System is a non-sterile,
reusable, metal guide with three components:
1. Tibial Guide Arm,
2. Tibial Guide Rail,
3. Tibial Guide Bullet
INDICATIONS FOR USE
The DePuy Mitek Tibial Guide System is intended for use
during anterior cruciate ligament reconstruction.
CONTRAINDICATIONS
None Known
WARNINGS
• Appropriate personal protective equipment and attire
should be worn when cleaning and sterilizing soiled
surgical instruments.
• Instruments may have sharp cutting edges that will
puncture skin.
PRECAUTIONS
• It is imperative that the surgeon and operating theater
staff are fully conversant with the appropriate surgical
technique for the surgical instruments.
• Inspect for damage prior to use. Replace a damaged,
worn or bent instrument. Do not attempt to straighten,
sharpen or repair.
• Do not use a DePuy Mitek reusable instrument for
any purpose other than its intended use as that may
result in damage to the instrument.
• Follow the instructions and warnings issued by the
suppliers of any cleaning and disinfection agents and
equipment used.
• Do not exceed 137ºC during sterilization.
• Complex devices, such as those with tubes, hinges,
retractable features, mated surfaces, and textured
surface finishes, require special attention during
cleaning. Manual pre-cleaning of such device features
is required before automated cleaning processing.
• Avoid exposing instruments to hypochlorite solutions,
as these will promote corrosion.
• Repeated processing has minimal effects on
instrument life and function.
• End of useful instrument life is generally determined
by wear or damage from handling or surgical use.
Inspect instruments between uses to verify proper
functioning. (See “Inspection and Functional Testing”
instructions below.)