Important Safety Information
AutoCart™ Procedure
GraftNet™ Device
INDICATIONS
The 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.
Thrombinator™ Device
INDICATIONS
The Thrombinator system for use with Arthrex PRP systems—the Angel concentrated platelet-rich plasma (cPRP) system or the 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.
Autograft OATS® Technique
INDICATIONS
The OATS system is designed for osteochondral autograft transplantation.
CONTRAINDICATIONS
Insufficient quantity or quality of bone for autograft harvesting. Non-localized degenerative changes to hyaline cartilage. 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. The use of this devise 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
Infections, both deep and superficial. Increased effusion or morbidity.
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. Autograft transplantation requires careful harvesting, precise sizing, and accurate placement of osteochondral autograft cylinders (grafts) with hyaline cartilage from a DONOR joint to a RECIPIENT joint. The length of the harvested osteochondral graft, referred to as DONOR, MUST precisely match the length of the socket created in the osteochondral lesion, referred to as (RECIPIENT). When inserting the osteochondral graft (DONOR) into the osteochondral socket (RECIPIENT), do not countersink the hyaline cartilage graft. Past and current scientific publications, surgical technique manuals, or surgical technique training on any media (print, DVD, video) relating to osteochondral autograft transplantation should be reviewed prior to the procedure. DO NOT disassemble the harvester/collared pin assemblies. Arthrex recommends manual-skills training on cadaveric or bovine specimens with associated instrumentation prior to the procedure. All potential harvest site locations should be researched and understood prior to the procedure. 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.
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.
