Important Safety Information
AutoCart™ Procedure
GraftNet™ Device
INDICATIONS
The Arthrex GraftNet device is designed to be used as an autologous tissue collection device during orthopedic surgery.
CONTRAINDICATIONS
The risk/benefit ratio of autologous sequestration must be determined on a case-by-case basis by the qualified medical personnel in charge of the patient’s care. The responsibility for the use of this device belongs solely to the physician in charge.
ADVERSE EFFECTS
Allergies and other reactions to device materials.
WARNINGS
Federal law restricts this device to sale by or on the order of a physician. This device is intended to be used by a trained medical professional. Do not resterilize this device. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user. When collecting autologous tissue(s), it is recommended to use sterile techniques to ensure that the autologous product is not contaminated. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.
BioCartilage® Extracellular Matrix
INDICATIONS
BioCartilage extracellular matrix is intended for use as an articular cartilage defect filler.
CONTRAINDICATIONS
BioCartilage extracellular matrix is contraindicated inpatients with known sensitivities or allergies to any of the agents listed below in the Warnings section and in patients who have an active systemic infection or any disorder that would create an unacceptable risk of postoperative complications.
ADVERSE EFFECTS
Possible adverse events may include immunologic response (the possibility that a patient may develop alloantibodies should be considered for any patient who might be a future recipient of allograft tissue or cells); transmission of disease of unknown etiology and transmission of infectious agents including but not limited to HIV, syphilis, or microbial contaminants; infection of soft tissue and/or bone (osteomyelitis); and fever.
WARNINGS
The donor of BioCartilage extracellular matrix is screened and tested for relevant communicable diseases and disease agents. BioCartilage extracellular matrix is processed using aseptic techniques, microbiologically tested, and may be exposed to gentamicin, vancomycin, and hydrogen peroxide. Although the tissue is rinsed using sterile water or sterile saline during the manufacturing process, trace amounts may remain. Although all efforts have been made to ensure the safety of the allograft, there is no assurance that this allograft is free from all infectious diseases or microbial contamination.BioCartilage extracellular matrix may transmit infectious agents.
Do not freeze the allograft by any method.
For use in one patient on a single occasion only.
Thrombinator™ Device
INDICATIONS
The Thrombinator system for use with Arthrex PRP systems—Arthrex Angel concentrated platelet-rich plasma (cPRP) system or Arthrex double-syringe (ACP) system)—is designed for the preparation of autologous serum from anticoagulated or non-anticoagulated peripheral blood, platelet-poor plasma, or PRP that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics.
CONTRAINDICATIONS
Blood supply limitations and previous infections, which may retard healing; any active infection or blood supply limitations; conditions that tend to limit the patient’s ability or willingness to restrict activities or follow directions during the healing period. Do not use for surgeries other than those indicated, as a dializer or for dialysis with a dialysate, or direct connection to patient’s vascular system of circulating blood volume.
ADVERSE EFFECTS
Infections, both deep and superficial; allergies and other reactions to device materials; hematoma; damage to blood vessels and nerve damage resulting in pain or numbness from autologous sampling; delayed wound healing.
WARNINGS
Federal law restricts this device to sale by or on the order of a physician This device is intended to be used by a trained medical professional. The autologous thrombin serum exhibits thrombin activity and therefore must not be injected into or otherwise allowed to enter the patient’s vascular system. Do not resterilize this device. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user. The safety and effectiveness of the device for bone healing and hemostasis has not been established. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.
Cartiform® Osteochondral Allograft
INDICATIONS
Cartiform is an osteochondral allograft. Cartiform is limited to the homologous use for the repair, replacement, or reconstruction of osteochondral/cartilage defects. The size and quantity of the product will vary based upon the defect size and physician recommendation. Donor eligibility screening and testing: All donors have been screened and tissue recovered, processed, stored, tested, and distributed in accordance with current US Federal Regulations as disseminated in 21 CFR 1271, current AATB standards, and state/local regulations as required. Cartiform was deemed suitable for transplant by Osiris Therapeutics, Inc. The medical director of Osiris Therapeutics, Inc. or physician designee, has determined that the donor of the tissue contained in this product is eligible to donate tissue for transplantation based on meeting the following criteria: (1) The results of donor screening indicated that donor was free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases, and is neither a xenotransplantation recipient nor a close contact of a xenotransplantation recipient, and (2) the results of donor testing by the following methodologies are negative or nonreactive: human immunodeficiency virus type 1 antibody (HIV), human immunodeficiency virus type 2 antibody (HIV), hepatitis C virus antibody (HCV), hepatitis B surface antigen (HBV), hepatitis B core antibody (HBV), syphilis rapid plasma reagin (RPR) or treponemal specific assay human T cell lymphotropic virus type I antibody (HTLV) human T cell lymphotropic virus type II antibody (HTLV), HIV/HCV/HBV nucleic acid test (NAT). Communicable disease testing was performed by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CUA) and 42 CFR Part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). The testing was conducted using FDA-licensed, -approved, or -cleared donor screening tests for testing cadaveric specimens for cadaveric donor screening following manufacturers' instructions for these tests. The records of this testing are maintained at Osiris at the address on this document.
CONTRAINDICATIONS
There are no known contraindications for this product.
WARNINGS AND PRECAUTIONS
Do not use if package integrity has been compromised. Once the user breaks the seal on the pouch, the tissue grafts must be transplanted or discarded. The tissue may not be sterilized. The same medical/surgical conditions or complications that may apply to any medical/surgical procedure may occur during or following transplant. The health care professional is responsible for informing the patient of the risks associated with his/her treatment and the possibility of any complications or adverse reactions. Caution should be exercised for patients with known sensitivities to the following reagents used for processing, disinfection, and storage and may remain on the product: Cryopreservation solution: 10% v/v dimethyl sulfoxide (DMSO), 20% v/v human serum albumin (HSA) (25% solution), 70% v/v sodium chloride (0.9% solution) Disinfection: povidone Iodine, 50 µg/mL gentamicin sulfate, 50 µg/mL vancomycin reconstituted in water for injection (WFI), 2.5 µg/mL amphotericin B, lX Dulbecco's Modified Eagle's Medium (DMEM), sterile water for injection Processing solution: sodium chloride irrigation solution (saline) Although the tissue has been tested and screened for human pathogens and processed under aseptic conditions, human derived tissue may still transmit infectious agents or diseases of known or unknown etiology including, but not limited to fungi, bacteria, or viruses (eg, HIV). Other complications of the tissue transplantation may occur, such as immune rejection of implanted HCT/P or loss of function and/or integrity of HCT/P.
Allograft OATS® and BioUni® Procedure
The allograft OATS and BioUni procedures are associated with certain risks, including graft delamination, lack of incorporation, and injury to the surrounding cartilage. An allograft may not be the correct choice for patients who have sensitivity to antibiotics and some cleansing agents.1 Talk to your doctor to learn more about potential complications and adverse reactions.
IntraOsseous BioPlasty® (IOBP®) Procedure
INDICATIONS
The Arthrex mixing and delivery system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate premixing of allograft, autograft, or synthetic bone graft materials with IV fluids, blood, plasma, platelet-rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
CONTRAINDICATIONS
Insufficient quantity or quality of bone; blood supply limitations and previous infections, which may retard healing; foreign body sensitivity; where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation; any active infection or blood supply limitations; conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. Do not use for surgeries other than those indicated.
ADVERSE EFFECTS
Allergies and other reactions to device materials; foreign body reactions.
WARNINGS
Federal law restricts this device to sale by or on the order of a physician. This device is intended to be used by a trained medical professional. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device. Do not resterilize this device. Do not reuse this device. A device labeled as a single-use device must never be reused. Reuse may pose health and/or safety risks to the patient that can include, but are not limited to cross-infection, breakage resulting in irretrievable fragments, compromised mechanical performance due to wear, lack of or no function, no guarantee of proper cleaning or sterilization of the device. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institution’s policy. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.
