Ortheon Medical

1. Does the Teno Fix® impede gliding of the tendon under the pulley system?
2. Does the Teno Fix® hinder blood supply or healing rate of the tendon?
3. What is the Teno Fix® device made of and why?
4. How strong is the Teno Fix® compared to the current suture techniques?
5. What other areas of the body can the Teno Fix® device be used?
6. What are the contraindications for the Teno Fix® device?
7. How does the device hold the tendon so securely?
8. Does the Teno Fix® device come in more than one size?
9. Can the Teno Fix® device be removed if improperly placed?
10. Can the FDS be repaired using the Teno Fix® device?
11. Does the Teno Fix® device interfere with an MRI?
12. Can the installation device or the crimper be reloaded?
13. Does the Teno Fix® device require an epitendinous suture to be used?
14. When I deploy the anchor, should I stop when the tendon starts to rotate?
15. Can the Teno Fix® be used to navigate the tendon back under the pulleys?
16. What is the proper way to open the sterile Teno Fix® System package?
17. Placing a distal anchor via the volar side of the tendon seems to not be feasible due to tendon thickness. What other option do I have in placing the anchor?
18. What are the options available to handle distal flexor lacerations?
19. Is there a way to manage distal avulsions of the flexor tendon using the Teno Fix® device?

The Teno Fix® device is designed to glide smoothly under the zone II pulley system of the digit. Each anchor is 3.5mm long by 2mm in diameter. This mass is offset by the unique ability to capture the collagen fibers and compress them between the coil and the core. The natural taper of the Teno Fix® anchor along with the intratendinous placement allow for minimal distention of the tendon decreasing the chance of an increased work of flexion or triggering of the tendon on the pulley system. The Teno Fix® device also requires a single 2-0 stainless steel suture to pass through the center of the injury reducing the bulking at the injury when compared directly to the number of sutures passing through the center of the injury in a standard suture repair. There should be no bunching at the repair site in a Teno Fix® repair due to the use of stainless steel which has no elastic properties as opposed to typical suture repairs utilizing polypropylene or nylon sutures that are expected to stretch.

In animal studies the post mortem histology at 6 weeks & 12 weeks post repair shows no compromise in the vascular supply which may impede healing.

The Teno Fix® device is comprised of implant grade surgical stainless steel. The body's reaction to implant grade stainless steel has been well studied and documented, as it has been used in the human body for more than 25 years.

The pullout force that obtained in the cadaver model is 45 Newtons. The unique capturing and compression of the collagen fibers of the tendon allow the device to use the high intrinsic strength of the tendon for a very strong repair. This allows for possible early active motion and the associated benefits. The 2-0 stainless steel suture has a >90 Newton tensile strength. The use of stainless steel eliminates the effects of gapping in the repair while the standard polypropylene suture repair which has a high elasticity rate, allowing stretching and gap formation. Gapping at the repair site of more than 2mm has been shown to reduce healing.

The TenoFix® device has been cleared by the FDA for use in severed or lacerated digital flexor tendons.

The contraindications of the Teno Fix® device used in tendons are:

• Lack of cutaneous coverage
• Inadequate osseous stability
• Conditions that may preempt patient healing such as necrotic or ischemic tissues

The use of this system is contraindicated in the patients with known sensitivities or allergies to the metals contained in stainless steel, i.e., chromium, nickel, copper, cobalt, and iron.

The device has a unique way of gathering the collagen fibers of the flexor tendon and wedging them between the coil and core portion of the anchor device. This harnesses the intrinsic strength of the flexor tendon. When force is applied to the tendon the fibers are pulled into the distal portion of the anchor allowing for a very strong hold reducing the chance of "rake out" as is often seen in the standard suture repair. The anchors on each end of the tendon are held together by a 2-0 stainless steel suture which has been cycled to over 26 million cycles and has a tensile strength of 90 Newtons (approximately 21lbs). As of May, 2007, a redesigned anchor, the Xtra, which replaced the original, increased the hold on the tendon by 50%.

At this time, the Teno Fix® device is only available in one size. The caution for this device is the ability of the tendon to accept the delivery device completely, thus ensuring proper anchor placement and seating. In fact, as of May, 2007, the anchor size was reduced by 50% to accommodate more tendon sizes.

Ortheon Medical provides an anchor removal device that can remove an improperly placed anchor with minimal trauma to the tendon. After removal of the anchor a new device may be inserted into the tendon.

There are no contraindications in repairing the Flexor Digitorum Superficialis with the Teno Fix® device. A surgeon should adhere to his/her normal technique in deciding whether repair of the FDS is necessary or may hinder the function of the Flexor Digitorum Profundus. The FDS, like the FDP, must be able to accept the delivery device in order to assure proper seating of the anchor.

The Teno Fix® device has been shown to be "MRI safe".

No. Ortheon is currently providing the device in a sterile, fully loaded, and ready to fire system. The delivery device and crimper are not re-loadable due to the close tolerances and complex mechanisms. Individual instruments are available separately in case of error which will help reduce costs by preventing the user from having to open a whole new kit.

Ortheon believes the surgeon should remain true to their usual surgical techniques in regard to the epitendinous suture.

The physician's assistant should provide gentle counter-traction to the rotation of the tendon upon deployment with a Mosquito or grasper by grasping mid substance. Even if there is some resistance felt during the anchor installation or if the tendon continues to rotate with counter-traction, completely fire the instrument to its hard stop.

For re-approximation of the repair site and tissue structure management, the surgeon should remain true to their usual surgical techniques. Other surgeons have utilized two techniques listed below to manage the tendon:

Option 1:

1. Install the Teno Fix® anchor and place the core suture.
2. Loop the core suture needle back towards the anchor to form a U-shape.
3. Feed a Mosquito or Fisher under the pulley to grasp the core suture and guide the tendon under the pulley. An elevator, tenolysis scalpel, or small forceps may need to be used to dilate a contracted pulley or some surgeons have bulleted the end of the tendon with an epitendonous stitch.

Option 2:

1. Install the Teno Fix® anchor and place the core suture.
2. Pass the core suture needle through a Kiddy Catheter.
3. Feed a Mosquito or Fisher under the pulley to grasp the Kiddy Catheter and guide the tendon under the pulley.An elevator, tenolysis scalpel, or small forceps may need to be used to dilate a contracted pulley or some surgeons have bulleted the end of the tendon with an epitendonous stitch.

1. When presenting to the sterile field, the circulating nurse should grasp the bottom of the tray with the Tyvek® lid and labeling facing themselves.
2. The circulating nurse should then grab the top right of the Tyvek® lid and peel down exposing the contents while pinching the bottom of the package.
3. Pinching the bottom of the package lifts up the inner sterile tray cover for the sterile nurse to pull out and discard.
4. The sterile nurse should push down on the circular (indented or dimple) area of the orange shipping tab on the Installation Instrument which lifts the end up to be grasped. Repeat with the second installation instrument.
5. The sterile nurse should grasp one arm of the Crimping Instrument near the proximal crimping end by the finger holes in the tray and pull the instrument out taking care not to pre-crimp or squeeze the device.
6. The sterile nurse should grasp the Suture Pack out of the tray and place it into the sterile field. The suture pack should be opened completely before removing the suture to prevent the suture from curling.
7. The circulating nurse may then discard the packaging.

Rather than making the tenotomy on the volar side of the tendon along the raphe, an option described by many surgeons is to make the incision along the radial or ulnar side of the tendon. After the tenotomy is made, the Teno Fix® anchor may be installed into that tenotomy keeping in mind that the goal of the placement is to install the anchor mid-substance along the centerline of the tendon.

For a laceration that is immediately proximal to the A4 pulley, several surgeons have utilized the following technique: (Also see Distal Repair Technique)

1. To manage the distal stump, an option is to bring the tendon out from under the A4 pulley in order to obtain exposure. The installation procedure of placing a Teno Fix® anchor can now be completed including the placement of the Teno Fix® stainless steel suture assembly.
2. After closing the tenotomy, encapsulating the Teno Fix® anchor, the Teno Fix® suture may now be used to navigate the distal stump back under the A4 pulley. Options to return the distal stump under the pulley are discussed in question 15.
3. The repair is then completed after placing the proximal anchor, delivering the stainless steel suture through the proximal anchor and crimping on the proximal side.

Some surgeons have utilized the Teno Fix® to resolve a rupture close to or at the point where the tendon inserts on the distal phalanx. A proximal anchor is placed as well as the stainless steel suture. The tenotomy is closed via a 6-0 Prolene (or equivalent) suture. A small hole is made in the distal phalanx and the Teno Fix® stainless steel suture is then passed through the hole and exteriorized out the nail. The stainless steel suture is then crimped on top of the nail with either a surgical button placed underneath the Teno Fix® stop bead. (See Distal Repair Technique)