Special Request Instrument for Use

QF-10-01-64-ENGL-A

Special Request Instruments Rx Only Caution: Federal Law restricts this device to sale by or on the order of physician Manufacturer: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008, USA Telephone: +1-760-727-8399 Fax: +1-760-727-8809 Complaints: [email protected] Customer Service: [email protected] Website: www.seaspine.com DESCRIPTION The SeaSpine® instruments shipped with this insert is designed for use in orthopedic surgical procedures for implantation of devices manufactured by SeaSpine Orthopedics Corporation. Prior to use of these instruments, please refer to the product instructions for use specific to the product line and the surgical procedure to be followed. INDICATIONS FOR USE The surgical instruments are intended to manipulate tissue or for use with other devices in orthopedic and spine surgery. MATERIALS One or more of the following materials: Stainless Steel, Silicone, Aluminum, Acetal (plastic), Polypropylene (plastic) CONTRAINDICATIONS Refer to the contraindications for specific Spinal Systems and implants that may be used with these surgical instruments. With any surgery, the following contraindications exist:  Infection in or around the operative site  Allergy or sensitivity to instrument materials  Use of incompatible materials from other systems  Any case not described in the indication INSPECTION Please inspect all instruments prior to use for possible damage, unacceptable wear, or non-functioning components. Damaged instruments should not be used. Contact your local sales representative or distributor for repair or replacement. WARNINGS AND PRECAUTIONS  SeaSpine instruments should only be used with SeaSpine implants. Do not attempt to use with other competitive devices.  Avoid application of excessive stress on surgical instrumentation.  Carefully read and follow any package insert which accompanies the implants to be used with this instrumentation.  Instruments must be cleaned and decontaminated before they are returned to the manufacturer for any reason.  Carefully inspect all instruments prior to use. Do not use an instrument that is severely marred or worn, or a cutting instrument with dull edges. Note that at some time, instruments may wear out and should be replaced. CLEANING AND DECONTAMINATION All surgical instruments that have been previously taken into a sterile surgical field must be decontaminated and cleaned using established hospital methods before sterilization and reintroduction into the sterile surgical field. The following recommendations are for the manual cleaning and decontamination of surgical instruments. These recommendations are considered guidelines with

Single Use Only Lot Number (Batch Code) Manufacturer

Catalog Number Non-Sterile Caution, Consult Accompanying Documents

Consult Instructions for Use

the ultimate responsibility for verifying adequate cleaning remaining with the user. Automated cleaning systems differ between hospitals and therefore must be qualified by the hospital. 1. Remove packaging materials and disassemble instruments, as appropriate. 2. Submerge products in a standard hospital grade enzymatic detergent for a minimum of 1 hour. PRECAUTION: Avoid cleaning solutions containing caustic soda, caustic disinfectants, formalin, glutaraldehyde, bleach or other alkaline cleaners as these may damage some instruments. 3. Clean with a soft bristle brush, lint free cloth or sponge for a minimum of 8 minutes to remove any visible soil. Special attention should be applied to hard to reach areas and tight lumens. 4. Rinse each product in a brisk stream of clean, room temperature tap water for a minimum of 2 minutes. 5. Soak again for a minimum of 30 minutes in a freshly prepared solution of the cleaning detergent. 6. Sonicate for a minimum of 30 minutes. 7. Once all visible soil has been removed, rinse immediately and thoroughly with running tap water for a minimum of 3 minutes to remove detergent residues. 8. Use de-ionized water as a final rinse. 9. Immediately dry product with a lint-free towel and allow to air dry. Sterile compressed air may be used to dry product. Inspect all products prior to sterilization or storage for evidence of wear or damage. STERILIZATION The recommended sterilization process is high temperature steam autoclave sterilization. It is also recommended that the trays be doubled wrapped using two standard sterilization wraps. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10ˉ6. Following AAMI ST79 guidelines, the validated sterilization cycle for a fully loaded tray is Method

Steam

Cycle Temperature and Exposure Time

Pre-vacuum

Drying Time

270°F (132°C) for 8 minutes 30 minutes

System or Implants. Contact a SeaSpine Representative, [email protected] or 760-727-8399 for specific product Surgical Technique Guide. COMPLAINTS Immediately notify SeaSpine or a SeaSpine representative by phone, fax or email regarding complaints, malfunctions or adverse events associated with this product. When possible, retain the product involved in the complaint and return to SeaSpine as instructed by SeaSpine Customer Service. PRODUCT INFORMATION DISCLOSURE SeaSpine has exercised reasonable care in the selection of materials and the manufacture of these products. SeaSpine warrants to the original purchaser only that each new SeaSpine product is free from manufacturing defects in material and workmanship under normal use and service for a period of six (6) months from the date of delivery by SeaSpine to the original purchaser, but in no event beyond the expiration date stated on any product labeling. SEASPINE DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). Further, this warranty shall not apply to, and SeaSpine shall not be responsible for, any loss arising in connection with the purchase or use of any SeaSpine product that has been repaired by anyone other than an authorized SeaSpine service representative or altered in any way so as, in SeaSpine’s judgment, to affect its stability or reliability, or which has been subject to misuse, negligence or accident, or which has been used otherwise than in accordance with these instructions. IN NO EVENT SHALL SEASPINE BE LIABLE FOR ANY SPECIAL, INCIDENTAL CONSEQUENTIAL, OR CONTINGENT LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM ACQUISITION OR USE OF THIS PRODUCT. SeaSpine neither assumes nor authorizes any person to assume for it any other additional liability or responsibility in connection with this product. SeaSpine intends that this device should be used only by physicians having received proper training in the use of the device.

PACKAGING If the package or product is damaged, the product should not be used and should be returned. The product must be handled, stored, and opened in such a way that it is protected from inadvertent damage or contamination. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked for damage before use. SURGICAL TECHNIQUE This package insert is designed to assist in using surgical instruments only and is not intended to provide information on surgical technique for specific Spinal Page 1 of 1