Advansor TF Instructions for Use

advansor-instructions-for-use2

CAUTION: Rx Only

Description:

The Advansor TF™ is a sterile, single-use surgical instrument intended for percutaneous release of the A1 pulley. The tip is inserted through a small skin incision and used to spread the subcutaneous tissues. The DPO retractor is used to visualize the proximal aspect of the flexor sheath. The tip of the device is pushed beneath the sheath, thus introducing the monorail track along the digit to the level of the distal aspect of A1. The blade is “guided” in the monorail track, allowing release of the pulley while protecting surrounding tendons and neurovascular structures.

Surgical Technique:

Read the Advansor TF Surgical Technique document (pdf)

Indications:

Trigger Finger Release of the A1 Pulley

Contraindications:

  • Active localized infection
  • Patients with severe flexor tenosynovitis
  • Dupuytren’s Contracture
  • Congenital Trigger Digits
  • Previous open release
  • Trigger Thumb

Warnings and Precautions:

  • Do NOT Re-use. The device is intended for single use only.
  • The Trigger Finger Device is to be used only as described by the surgical technique included in the procedure pack.

Possible Adverse Effects:

  • Infection
  • Incomplete release of the A1 pulley
  • Instrument failure
  • Tendon injury and/or scarring
  • Neurovascular damage

How Supplied:

This product and its packaging have been sterilized with ethylene oxide gas (EtO).

Storage and Handling:

Store in a cool, dry place and keep away from direct sunlight. Prior to use, inspect product packaging for signs of tampering, damage or water contamination.

Manufactured for:
Del Palma Orthopedics, LLC
5865 E. State Road 14
Columbia City, IN 46725
(888) 875-4376