DynaNail Mini® Fusion System - Product Information | MedShape, Inc.

PR O D U C T INFORM ATION

FEATURING PATENTED SUPERELASTIC NiTiNOL TECHNOLOGY

IT’S SUPERELASTIC! THE “RUBBER-BAND” EFFECT. The DynaNail Mini features MedShape’s patented and proven superelastic NiTiNOL technology.1,2 The internal NiTiNOL Compressive Element is stretched (1 in below graph) and fixed with screws (2). Post-surgery, the NiTiNOL Element will automatically recover its stretched length due to unloading in response to bone resorption or settling (3), analogous to a very strong rubber band.

NiTiNOL Stress Strain

2

1

Unloa

d

The DynaNail Mini® Fusion System is designed for use in subtalar fusion and in the fusion of other large bones in the foot and ankle.

“I was initially attracted to the DynaNail Mini due to its excellent post-operative

Stress

Stretch

Pseudoelastic Recovery

compression, particularly in patients with poor bone quality. From my experience so

3

far, I have found the nail to be easy to use and the results reproducible across my patient population.”

0

– Terrence Philbin, DO Orthopedic Foot & Ankle Columbus, Ohio

0

1

2

3

4

5

6

7

Strain (%)

“As a big believer in the dynamic compression capabilities of NiTiNOL in promoting fusion, I am pleased to add the DynaNail Mini to my arsenal of surgical tools.

NEW! PRE-LOADED ASSEMBLY

The DynaNail Mini offers the same benefits of sustained post-operative compression as its predecessor, the DynaNail, but now in a smaller size expanding the use of NiTiNOL to other indications.”

The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Just connect the Nail Guide to the Mini Targeting Frame and implant!

– Kent Ellington, MD OrthoCarolina Foot & Ankle Institute Charlotte, North Carolina Internal NiTiNOL Element 1-Yakacki CM, Gall K, Dirschl DR, Pacaccio DJ. Pseudoelastic intramedullary nailing for tibio-talo-calcaneal arthrodesis. Expert Rev Med Devices 2011; 8(2): 159-66.

2-1.Ford SE, Kwon JY, Ellington K. Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients. J Foot Ankle Surg, 2019. 58(2): 266-272.

3-Data on File, MedShape, 2019.

Nail Outer Body

Nail Guide

THE SAME MAINTAINED COMPRESSION PERFORMANCE. NOW IN A SMALLER FORM

• Offers between 2-4 mm of post-operative compression PLUS intra-operative manual compression Transverse Screw

• Provides strong joint stability due to maintained compression • Dual transverse screw fixation to prevent device migration

Titanium Outer Nail Body

Maintained Active Compression Unlike traditional screws that lose compression within 1 mm of bone resorption, the DynaNail Mini is the ONLY internal device for subtalar fusion procedures that maintains active compression post-surgery in response to bone resorption or settling. The amount of compression maintained varies by the length of the Mini Implant.3 Amount of available post-operative compression by implant length Nail Length

Internal NiTiNOL Compressive Element

Compression

60 mm

1.8 mm

70 mm

2.2 mm

80 mm

2.8 mm

90 mm

3.4 mm

100 mm

4.0 mm

Slotted Calcaneal Screw Hole

Transverse Screw Sliding Element

WATCH THE COMPRESSIVE ELEMENT IN ACTION 11 Weeks Post-Surgery X-Ray of 70 mm DynaNail Mini implanted in 81 year old female.

**

1 mm 1 mm

**

The distance the NiTiNOL Element recovers can be measured and tracked on x-ray post-surgery. In this case, with a 70mm, the Calcaneal Screw is located 1 mm from proximal end of Nail Outer Body slot indicating the NiTiNOL Element has recovered 1.2 mm of its stretched length with 1 mm of compression remaining.

Images courtesy of Terrence Philbin, DO (Orthopedic Foot & Ankle, Columbus, OH)

Targeting Arm

DYNANAIL MINI TARGETING FRAME

• Manufactured out of durable carbon-fiber PEEK Bone Apposition Sleeve

• Rigid, robust construction for accurate targeting and screw placement • Radiolucent to permit radiographic visualization

Manual Compression Wheel

Lasermarked numbers indicate order of steps

Retention Knob

DYNANAIL MINI IMPLANTS

DYNANAIL MINI SINGLE USE INSTRUMENTS

Part No.

Description

Part No.

Description

2600-00-7060

DynaNail Mini, 7 mm x 60 mm

2200-19-0020

Steinmann Pin, 2 mm x 9"

2600-00-7070

DynaNail Mini, 7 mm x 70 mm

2900-16-070

Cannulated Drill, 7.0 mm

2600-00-7080

DynaNail Mini, 7 mm x 80 mm

2900-16-075

Cannulated Drill, 7.5 mm

2600-00-7090

DynaNail Mini, 7 mm x 90 mm

2900-16-080

Cannulated Drill, 8 mm

2600-00-7100

DynaNail Mini, 7 mm x 100 mm

2900-16-085

Cannulated Drill, 8.5 mm

2600-00-8060

DynaNail Mini, 8 mm x 60 mm

2900-03-0400

Transverse Screw Drill, 4 mm

2600-00-8070

DynaNail Mini, 8 mm x 70 mm

2900-04-0380

Stepped Guidewire, 2.4 mm x 380 mm

2600-00-8080

DynaNail Mini, 8 mm x 80 mm

2600-00-8090

DynaNail Mini, 8 mm x 90 mm

2600-00-8100

DynaNail Mini, 8 mm x 100 mm

2600-03-4322

Headless Screw, 4 mm x 22 mm

2600-03-4324

Headless Screw, 4 mm x 24 mm

2600-03-4326

Headless Screw, 4 mm x 26 mm

2600-03-4328

Headless Screw, 4 mm x 28 mm

2600-03-4330

Headless Screw, 4 mm x 30 mm

2600-03-4332

Headless Screw, 4 mm x 32 mm

2600-03-4334

Headless Screw, 4 mm x 34 mm

2600-03-4336

Headless Screw, 4 mm x 36 mm

2600-03-4338

Headless Screw, 4 mm x 38 mm

2600-03-4340

Headless Screw, 4 mm x 40 mm

2600-05-0000

Endcap

For further product information or to arrange a product demonstration, please contact your local MedShape representative or call Customer Service at 877-343-7016.

You can also visit www.medshape.com.

CHECK OUT THE ENTIRE DYNANAIL® PRODUCT LINE!

Available in 220, 260, and 300 mm lengths for use in tibiotalocalcaneal (TTC) fusion procedures.

MedShape, Inc. 1575 Northside Drive, NW Suite 440 Atlanta, GA 30318 T: 877-343-7016 F: 877-343-7017

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ©MedShape, Inc., 2019. All rights reserved. Printed in the USA. MK-10173 Rev. 00. Issued 09/2019. Pat.: http://www.medshape.com/patents.html.

DynaNail is a registered trademark of MedShape, Inc. All other trademarks are trademarks of their respective owners or holders.