Advansor TF Instructions for Use
CAUTION: Rx Only
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.
Trigger Finger Release of the A1 Pulley
- 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:
- Incomplete release of the A1 pulley
- Instrument failure
- Tendon injury and/or scarring
- Neurovascular damage
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.
Del Palma Orthopedics, LLC
5865 E. State Road 14
Columbia City, IN 46725