Drill Guide for Suture Anchor Placement Instructions for Use

Parcus Drill Guide for Suture Anchor Placement (English) 1. Indications: Parcus Drill Guides are provided in various configurations to assist in the placement of suture anchors and/or drill bits. 2. Warnings: A. Caution: Federal law restricts this device to sale by or on the order of a physician. B. Parcus Drill Guides are supplied unsterile as reusable devices. C. Never use a bent or damaged drill guide or obturator. D. This product is not intended for use as an implant. E. Loading this instrument or any instrument used with this device in an off-axis manner may result in breakage or bending of the instrument, drill guide or obturator. 3. Material: The materials used in the manufacture of this device that are intended to be used inside the body are Stainless Steel Alloy and are, therefore, radio-opaque and can be detected with conventional X-Ray or fluoroscopy. Other parts of the device that are not used inside the body may be manufactured from Stainless Steel Alloy, Aluminum or Plastic. No part of this device is intended to be implanted in the body. 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. D. The device should be placed in an ultrasonic cleaning unit and processed according to the unit’s directions. E. The device should be rinsed thoroughly with water following the ultrasonic process. 6. Sterilization: This device is not provided sterile. The following table provides recommended minimum sterilization parameters that have been validated by Parcus Medical to provide a 10-6 sterility assurance level (SAL): Minimum Minimum Exposure Minimum Dry Cycle Type Temperature Time (Wrapped) Time Pre-vacuum

132°C / 270°F

4 minutes

30 minutes1

1 Drying times vary according to load size and should be increased for larger loads.

7. Instructions for use: A. Place the Drill Guide with obturator, as applicable, on the targeted bone through an open incision, percutaneously, or through an arthroscopic cannula. B. Remove obturator, as applicable, and advance the required instrumentation through the guide to the desired depth. C. Remove the instrumentation from the guide.