Parcus Tibial Plug Directions for Use

Parcus Tibial Plug 1. Indications: Parcus Tibial Plugs are used during ACL/PCL ligament repair or reconstruction procedures to limit the loss of irrigation fluid from the knee joint. The Parcus Tibial Plugs are supplied in two configurations; solid and with a 2.4mm cannulation. Both designs are tapered to accommodate tunnels from 7mm to 12mm in diameter. 2. Warnings: A. This product is intended for use by or on the order of a physician. B. Do not use this product if it shows any visible signs of damage. C. This device is not intended to be used to dilate the tibial tunnel. Care should be exercised when placing the plug to prevent fracture of the proximal tibia. D. This device is not intended to be used as an implant. 3. Material: This device is comprised of PEEK, is radiolucent, and may be visualized through the use of ultrasound or MRI. 4. Inspection: A. Inspect the device for damage at all stages of handling. B. If damage is detected, consult the manufacturer for guidance. 5. Cleaning: A. Immediate rinsing and cleaning after use with an enzymatic detergent will effectively remove and prevent drying of adherent blood, tissue, etc. B. Scrub device with a soft brush, paying special attention to areas where debris might accumulate. Always avoid any harsh materials that can scratch or mar the surface of the device. C. Rinse the device thoroughly with water following the cleaning process. 6. Sterilization: This product is a non-sterile item that must be cleaned and sterilized prior to use. The following table provides recommended minimum sterilization parameters that have been validated by Parcus -6 Medical to provide a 10 sterility assurance level (SAL):

1

Cycle Type

Minimum Temperature

Minimum Exposure Time (Wrapped)

Gravity

132°C / 270°F

15 minutes

Pre-vacuum

132°C / 270°F

4 minutes

Minimum Dry Time 30 minutes

1

Drying times vary according to load size and should be increased for larger loads 7. Directions for use: A. Create a tibial tunnel that is 7mm to 12mm in diameter. B. If a guide wire is present in the tunnel, select the cannulated version of the Parcus Tibial Plug. The cannulation is 2.4mm in diameter. If no guide wire is present, the non-cannulated Plug can be used. C. Gently press the tapered end of the Plug into the tunnel until an interference fit, sufficient to keep the Plug in place, is achieved. D. Remove the Plug to pass instruments, graft material and suture. E. Replace the Plug, described in Step C, as necessary.