i. Implants i. Systems1. Surgical material2. Surgical approach I3. Application I4. Surgical approach II5. Application II6. Osteotomy 7. Finishing

MouseNailSurgical technique guide

Intramedullary fixationStabilization of a single cut / large gap osteotomy with a locked intramedullary nail. Possible osteotomy sizes from 0.25 to 2.00 mm. A fracture model is also possible.

i. ImplantsTechnology

The MouseNail system is a locked intramed-ullary nail made of medical grade stainless steel 1.4441 (316L). The implant is available in one standard size allowing for osteotomies from 0.25 to 2.00 mm. The pin driver for insertion of the locking pins is an integral component of the pin design and shears off once sufficient torque is applied.The locking pin is designed to extend over the opposite cortex and makes unlocking for implant removal possible.For practical application of the MouseNail an aiming device with various saw guide clips is available.

i

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MouseNail locking pin

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The MouseNail system can cover single cut osteotomies up to large bone defects within the femur.

i. Systems

MouseNail with 0.25 mm osteotomy

MouseNail with 2.00 mm osteotomy

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Implants:- 1x MouseNail - 2x MouseNail locking pin

1. Surgical material

Implant specific instruments:- 1x MouseNail aiming device- 1x Saw guide 0.25 mm

Instruments:- 4x hand drills - 1x Accu Pen 3V

Consumables:- 1x 0.30 mm Drill bit- 1x 0.22 mm Gigly wire saw, 0.50 m- 1x 1.00 mm centering bit- 1x 24-G/27-G needle, length > 19 mm- 1x Vicryl suture 3-0 & Vicryl suture 5-0 - 1x Ethibond Vicryl suture 6-0

RIS.221.122 MouseNail wide interlocking

RIS.221.121 MouseNail locking pin

RIS.390.130 Hand drill

RIS.390.200 AccuPen 3V

RIS.590.100 Gigly wire saw 0.22 mm

RIS.590.200 Drill Bit 0.30 mm

RIS.221.201 MouseNail aiming device, wide interlocking RIS.321.101 MouseNail Sawguide, 0.25mm

RIS.592.205 Centring Bit 1.00 mm

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Positioning

Mouse in dorsal position.

2. Surgical approach I

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Positioning

The knee is bent according to illustration.

2. Surgical approach I

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Dorsal approach

Longitudinal incision along the medial side of the patella from the distal third of the thigh to the proximal third of the lower leg.

2. Surgical approach I

MouseNail

Dorsal approach

Longitudinal incision along the medial side of the patellar tendon.

2. Surgical approach I

MouseNail

Dorsal approach

Lateral dislocation of the patella to expose the knee joint.

2. Surgical approach I

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Dorsal approach

Position of the intercondylary entry point of the femur.

2. Surgical approach I

X

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Opening of the epicondyle

Use the 1.00 mm centring bit to drill a hole into the intercondylar notch. According the illustration start drilling with a 45 ° offset to the axis of the femur and continuously decrease the angle to 0° offset (parallel with the bone axis). Make sure not to exceed 2.00 mm in depth for the drill hole !

Verify the orientation of the longitudinal axis and keep the centering bit right between the two condyles of the medullary cavity and parallel to the bone axis.

3. Application I

MouseNail

Proximal opening of femur

Use a 22G needle (length > 19 mm) to ream the medullary cavity. Again make sure that the needle is central to the medullary cavity and parallel to the bone axis ! Open the femur proximally with a 27G needle (length > 19mm) to prepare the insertion of the MouseNail.

3. Application I

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3. Application IInsertion

Insert the MouseNail under continous rota-tion until the distal end of the MouseNail is flush with the epycondyle.Make sure to apply smooth axial presure during insertion.

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MouseNail in situ.

3. Application I

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Positioning

Mouse in lateral position.

4. Surgical approach II

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Anterolateral approach

Longitudinal incision along the femur from the hip joint to the knee.

4. Surgical approach II

MouseNail

Anterolateral approach

Longitudinal incision of the fascia lata.

4. Surgical approach II

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Anterolateral approach

M. vastus lateralis and M. biceps femoris are split and M. tensor fasciae latae is lifted to expose the full length of the femur (preserv-ing the sciatic nerve).

4. Surgical approach II

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Anterolateral approach

Circular preparation of the femur.

4. Surgical approach II

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Assembly

Mount the aiming device to the MouseNail.

Pay special attention to the final position of the aiming device. If there is a gap between the MouseNail adapter flanch and the inner surface of the aiming device (marked in red) than the aiming device needs to be advanced more until the stop on the Mouse-Nail and the inner surface get in contact.

5. Application II

MouseNail

Orientation of the aiming device

Position the aiming device anterolaterally to the femur.

Interlocking of the MouseNail

Starting with the more distal interlocking position use the 1.00 mm centering bit to prepare for drilling. Maintain the orienta-tion of the aiming device and drill the first interlocking hole with the 0.3 mm bit. The countersinking as well as the drilling should be done by hand without the use of power tools ! Carefully apply the MouseNail locking pin via the aiming device and bring it into its final position by turning it into the MouseNail under continuos axial load. The locking pin drive shaft shears of as soon as the interlock-ing torque is achieved. Repeat this for the remaining interlocking position.

5. Application II

1. countersinking 2. drilling 3. interlocking

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6. OsteotomyPerforming the osteotomy

Attach the 0.25 mm saw guide on the lateral side of the aiming device and create a de-fined gap by using the Gigly saw (sufficient irrigation !) To avoid damage of the soft tissue cut the saw wire close to the bone on either side.

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6. OsteotomyAccomplishing the osteotomy

Remove the aiming device from the MouseNail and disconnect the shaft of the MouseNail at the groove (marked red).

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7. FinishingWound closure

Lift the M. quadriceps gently over the femur to its original position. Use Ethibond vicryl suture 6-0 to close the muscular layer, the fascia lata as well as the skin.

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Wound closure

Use Ethibond vicryl suture 6-0 on the patel-lar tendon and the fascia lata.

7. Finishing

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7. FinishingWound closure

Skin suture with Ethibond vicryl suture 6-0.

To avoid wound biting it is also possible to use skin glue instead of a suture.

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Hazards and legal restrictionsScientific editor: Moritz Klein, Germany; Patric Garcia, GermanyIllustrations: Sandra Wissing, SwitzerlandDesign and layout: Romano Matthys, Switzerland In collaboration with: University of Saarland, Germany Trauma, Hand and reconstructive Surgery Director: Tim PohlemannHazards Great care has been taken to maintain the accuracy of the information contained in this publication. However, the publisher, and/or the distributor, and/or the editors, and/or the authors cannot be held responsible for errors or any consequences arising from the use of the information contained in this publication. Contributions published under the name of individual authors are state-ments and opinions solely of said authors and not of the publisher, and/or the distribu-tor, and/or the RISystem Group. The products, procedures, and therapies described in this work are hazardous and are therefore only to be applied by certified and traine medical professionals in environments specially designed for such procedures.

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No suggested test or procedure should be carried out unless, in the user‘s professional judgment, its risk is justified. Whoever applies products, procedures, and therapies shown or described in this work will do this at their own risk. Because of rapid advances in the medical sciences, RISystem recommends that independent verification of diagnosis, therapies, drugs, dosages, and operation methods should be made before any action is taken. Although all advertising material which may be inserted into the work is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement by the publisher regarding quality or value of such product or of the claims made of it by its manufacturer.

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