Indications, Safety & Warnings

UltraGuideTFR™

Intended Use:

UltraGuideTFR is a single-use, hand-held orthopedic manual surgical instrument to be used for trigger finger release.

Indications for Use:

UltraGuideTFR is indicated for the treatment of stenosing tenosynovitis (known as trigger finger) by incising the tendon sheath and A1 pulley, and as needed part of the A2 pulley (Excluding thumbs).

Contraindications:

  • Presence of infection.
  • Distorted anatomy, deformity, or other processes within the hand or finger preventing safe and effective incision of the tendon sheath and pulley.
  • Presence of a condition requiring surgical intervention beyond incision of the tendon sheath and pulley.
  • Use of the device on thumbs.
  • Additionally, in cases in which ultrasound guidance is used, inability to sonographically identify and protect relevant anatomic structures such as the arteries, veins, and nerves.

Possible Complications:

Operators should be familiar with the complications of trigger finger release using UltraGuideTFR, including but not limited to:

  • Procedure related discomfort.
  • Infection.
  • Wound complications such as delayed healing, scarring, tenderness and tenosynovial fistula.
  • Bruising.
  • Injury to arteries, veins, tendons, or other soft tissues.
  • Skin laceration.
  • Injury to nerves such as the digital nerves.
  • Injury to the A2 pulley.
  • Development of a chronic pain process such as complex regional pain syndrome.
  • Stiffness and/or tenosynovitis.
  • Recurrence of symptoms.
  • Incomplete symptom resolution.
  • Additionally, in cases in which ultrasound guidance is used, inability to complete the trigger finger release with ultrasound guidance requiring discontinuation of the procedure.

Warnings:

  • Safe and successful incision of the tendon sheath and A1 pulley (and as needed a portion of the A2 pulley) using UltraGuideTFR is dependent upon appropriate training, medical expertise regarding stenosing tenosynovitis (i.e., trigger finger) and careful study and adherence to the surgical technique. Failure to properly follow the instructions, warnings and precautions may lead to serious surgical consequences or injury to the patient or operator.
  • Use of UltraGuideTFR in conjunction with ultrasound guidance should only be performed by operators experienced in ultrasound guided procedures and who are properly trained and familiar with the correct operation of UltraGuideTFR as outlined in this document.
  • The safety and effectiveness of UltraGuideTFR to incise the tendon sheath and pulley in cases of recurrent stenosing tenosynovitis/trigger finger has not been established.
  • The cutting Blade of UltraGuideTFR is extremely sharp. Exercise caution to prevent injury.
  • Device misuse may damage the device, resulting in an inability to complete the procedure or potential injury.
  • If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored.
  • Following use, the device must be properly discarded as outlined in this document.
  • Do NOT Re-sterilize. Single Use Only. Do not attempt to clean, re-sterilize, or resharpen this device. After use, this product may be a potential biohazard.
  • UltraGuideTFR is to be used only as described by the surgical technique. The operator should be familiar with the surgical procedure prior to performing the surgery.
  • Postoperative care is important. The patient should be warned that failure to follow post-operative care instructions can lead to failure of the procedure or increase the risk of complications. The patient should be made aware and warned of the general surgical risks and the possible adverse effects as listed.

Precautions:

  • Operators using UltraGuideTFR should be familiar with the surgical technique and the required instrumentation.
  • Operators using UltraGuideTFR in conjunction with ultrasound guidance should be familiar with the use of ultrasound for interventional procedures.
  • Trigger Finger release using UltraGuideTFR represents a surgical procedure. Operators and staff should follow appropriate precautions and procedures.
  • The position of the patient’s hand and finger should be controlled during the procedure. Unwanted hand or finger movement may make the procedure more difficult or result in injury.

Product Users/Use Environment:

  • Customers: The device should be used by properly trained health care providers in hospital and clinic settings.
  • Users: The device should be used by a physician, surgeon, or other medical personnel qualified to perform a trigger finger release and/or ultrasound guided procedures (herein referred to as the operator).
  • Use Environments: Procedure room in a clinical facility such as an outpatient facility, physician’s office or a hospital.