Important Safety Information
InternalBrace™ Technique / TightRope® Device
Indications
TightRope devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small-bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Arthrex ACL/PCL/BTB/RT/ABS TightRope and TightRope II are used for fixation of bone-to-bone or soft–tissue-to-bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction; MCL, POL, LCL repair and reconstruction; ITB and PTR repair (except in Canada); and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction (except in Canada).
Contraindications
Insufficient quantity or quality of bone; blood supply limitations and previous infections, which may retard healing; foreign body sensitivity; foreign body reactions; 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.
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.
Adverse Effects
Infections, both deep and superficial; foreign body reactions; allergic-like reactions to polylactic acid (PLA), poly-L-lactic L acid (PLLA), poly-L-D-lactic acid (PLDLA) have been reported, and have sometimes necessitated the removal of the implant. Patient sensitivity to device materials must be considered prior to implantation. Silicone sensitivity, though very rare, has been reported.
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. An internal fixation device must never be reused. Do not resterilize this device. ACL/PCL/BTB/RT/ABS TightRope devices are not intended to be used as a ligament replacement. Do not add additional suture to the ACL TightRope device. The extra suture may impede passage of the device through the femur. All metallic implant devices used for this surgical procedure should have the same metallurgical composition. Therefore, different material implants are provided. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight-bearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device and bone. 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. The appropriate Arthrex delivery system is required for proper implantation of the device. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Device removal should be followed by adequate postoperative management. 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. Removal of supplemental fixation after healing. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. Patient sensitivity to the device materials should be considered prior to implantation. See Adverse Effects. Once open, discard any unused suture. 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.
BioACL™ Technique / AlloSync™ Demineralized Bone Matrix
Indications
This human tissue allograft is processed and manufactured by CellRight Technologies. All tissue was retrieved, processed, stored, and distributed for use in accordance with the standards of the American Association of Tissue Banks (AATB), FDA requirements for Human Cellular and Tissue Based Products (HCT/Ps 21 CFR Part 1271), and applicable State regulations. The donor has been determined to be eligible based on the results of screening and testing. Screening includes a review of medical and social history, available hospital records, infectious disease screening, autopsy report (if performed), and physical exam. The donor has been tested and was found negative or non-reactive for human immunodeficiency virus types 1 and 2 antibody (anti-HIV-1/anti-HIV-2), hepatitis B surface antigen (HBsAg), hepatitis B core antibody - total (anti-HBc), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus 1 and hepatitis C virus nucleic acid test (HIV 1/HCV NAT), syphilis rapid plasma reagin or treponemal specific assay. Additional tests, including but not limited to HTLV I/II and HBV nucleic acid testing, may have been performed and were found to be acceptable for transplantation. US Food and Drug Administration (FDA) licensed, approved, or cleared donor screening test kits are used when available. Communicable disease testing has been performed by a laboratory registered with the FDA to perform donor testing in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). A list of additional communicable disease test(s) performed will be provided upon request. The CellRight Technologies Medical Director has determined this donor tissue to be suitable for transplantation. The testing and medical release records are maintained by CellRight Technologies. The names and addresses of the testing laboratories, the interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are kept on file at CellRight Technologies and are available upon request. Tissue has been sterilized, using Cobalt 60, to a sterility assurance level of 10-6. Allografts are processed using some or all of the following agents: physiological buffers, acids, alcohols, surfactants, hydrogen peroxide, gentamicin sulfate, vancomycin HCl, amphotericin B, polymyxin B, and/or ciprofloxacin and traces may remain.
Adverse Effects
Adverse outcomes potentially attributable to this tissue must be reported promptly to Arthrex, Inc., at 1-800-933-7001, ext. 78718, or email at: Complaints@Arthrex.com.
Warnings
Intended for use in one patient, on a single occasion only. Do not use if package integrity has been compromised. Once the user breaks the seal on the inner-most pouch, the tissue grafts must be transplanted or discarded. Tissue may not be sterilized or resterilized. This tissue is intended for use by qualified healthcare specialists such as physicians, dentists, or podiatrists. Although this tissue has been tested and screened for human pathogens and processed under aseptic conditions, human-derived tissue may still transmit infectious agents. It is the responsibility of the tissue-dispensing service, tissue distribution intermediary, and/or end-user clinician to maintain tissue intended for transplantation in appropriate storage conditions prior to further distribution or transplant.
Arthrex Angel® System
Indications
The Arthrex Angel System Kits are to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet-poor plasma and platelet concentrate (platelet-rich plasma) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The platelet-poor plasma and platelet-rich plasma are mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
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. 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. 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.
Adverse Effects
Infections, both deep and superficial; foreign body reactions; hematoma.
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. 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. 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. Failure to use this device in accordance with the directions for use may result in device failure, render the device unsuitable for its intended use, or compromise the procedure. 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.
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.