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Surgical Technique Surgical Protocol by Dmitry Sandler, DPM. ReUnite ® Small Screws Fixation System Hallux Valgus Correction

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Page 1: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Surgical Technique

Surgical Protocol by Dmitry Sandler, DPM.

ReUnite® Small Screws Fixation System

Hallux Valgus Correction

Page 2: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Over 1 million times per year, Biomet helps one surgeon

provide personalized care to one patient.

The science and art of medical care is to provide the right

solution for each individual patient. This requires clinical

mastery, a human connection between the surgeon and the

patient, and the right tools for each situation.

At Biomet, we strive to view our work through the eyes of

one surgeon and one patient. We treat every solution we

provide as if it’s meant for a family member.

Our approach to innovation creates real solutions that assist

each surgeon in the delivery of durable personalized care

to each patient, whether that solution requires a minimally

invasive surgical technique, advanced biomaterials or a

patient-matched implant.

When one surgeon connects with one patient to provide

personalized care, the promise of medicine is fulfilled.

One Surgeon. One Patient.®

Page 3: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Figure 1 Figure 2

IncisionMake a 3.5–4 cm linear incision beginning proximal to the first metatarsal head and extending distally to the base of the proximal phalanx (Figure 2).

Caution: If the incision is too short, it may be difficult to perform the interspace release adequately.

Pre-Operative Protocol/Patient PositioningPlace the patient in the supine position with a bump under the ipsilateral hip (Figure 1). Moderate sedation is performed by anesthesia. Administer 10 cc .5% Marcaine plain in a mayo block fashion.

This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not practice medicine or recommend any particular product or technique for a specific patient.

Hallux Valgus Correction

ReUnite® Small Screws Fixation System

Page 4: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

4

ReUnite® Small Screws Fixation SystemHallux Valgus Correction

Figure 3 Figure 4

Soft Tissue ReleasesMake a capsular incision linear to the skin. An L-incision can be utilized if preferred (Figures 3 & 3A). Use a periosteal elevator to facilitate removal of the dorsal periosteum. Attention is then directed to a lateral release. Perform a lateral release by dissecting down to the superficial fibers of the deep transverse intermetatarsal ligament and release the ligament.

Find the adductor hallucis tendon, release the tendon from base of proximal phalanx. Next shell out the fibular sesamoid and transect adductor tendon at myotendi-nous junction.

Ensure the sesamoid is freed distally, proximally and laterally leaving only the intersesamoidal ligament (Figure 4).

Figure 3A

Page 5: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

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Bony CutsUsing a sagittal saw blade resect the enlarged dorsomedial eminence. Orient the cut obliquely so that less bone isremoved plantarly (Figure 5/5A).

Perform a Chevron/Austin osteotomy with the apex dis-tally. The osteotomy is made perpendicular to original cut, to allow for ease of plantarflexion as the capital fragment is shifted laterally (Figure 6 / 6A).

The capital fragment should be shifted approximately 3–5 mm depending on the size of patient and deformity (Figure 7).

Surgeon Tip: This surgeon prefers to have the medial condyle of proximal phalanx to overhang slightly as a guideline.

Figure 5 Figure 7

Figure 6

Figure 6A

Figure 5A

Page 6: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

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ReUnite® Small Screws Fixation SystemHallux Valgus Correction

Drill Holes for ScrewsTo secure the osteotomy, a resorbable 2.8 mm screw is used. Create guide holes prior to using the drill. A 2.0 mm Steinmann pin is chucked to a drill and a guide hole is cre-ated. This is done bicortically. Both drill holes are prepared at this time. One pin is left in the proximal hole to hold the fixation (Figures 8/8A).

Figure 8 Figure 9

Figure 8A

Next, insert the appropriate drill sleeve into the guide handle (Figure 9).

Page 7: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

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Chuck up a 2.2 mm drill bit non-cannulated and drill bicortically to create the drill hole in the same orientation as the Steinmann pin. (Drilling by hand is preferred due to better control of depth) (Figures 9A /10 ). The hole for the ReUnite® 2.8 mm resorbable screw is now created.

Measure Hole DepthTo determine the length of screw required measure the length of the drill hole with depth gauge provided (Figure 11). Use a 13 –17 mm screw length depending on the size of patient and bone.

Figure 11Figure 9A

Figure 10

Page 8: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

8

ReUnite® Small Screws Fixation SystemHallux Valgus Correction

Nom

inal

Len

gth

TapIn preparation for the screw, tap bicortically with a 2.8 mm tap. Insert the appropriate tap sleeve into the guide handle. (Tapping by hand is preferred in order to allow better control of the thread pattern.) The hole must be fully tapped the entire threaded length of the screw (Figure 12).

Note: The length of tap threads measures 17 mm in length.

Insert ScrewsIdentify the required implant (Figure 13). Prior to insertion, dip the screw in saline to stimulate expansion (this is not required). To insert the screw, insert the hex head of the screw into the socket of the driver (Figure 13A).

Figure 12 Figure 13A

Figure 13

Page 9: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

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The screw is then inserted perpendicular to the dorsal wing of osteotomy (Figure 14). When the screw is fully seated, an additional turn of the driver will shear off the hex head, leaving the low-profile head intact (Figure 14A). The spent hex head may be ejected from the driver by pushing the driver handle on the device.

The head can be discarded. Then utilize the screw removal tool to finalize seating of the screw head (Figure 15).

The proximal Steinmann pin is then removed. If a secondary screw is required to prevent rotation follow these same steps again. This is usually determined by the length of the dorsal arm (if longer, the use of two screws may be appro-priate per the surgeon’s discretion). If minimal correction is needed a nail can be used proximally usually 14 mm or 18 mm in length to secure fixation.

Figure 14

Figure 14A

Figure 15

Page 10: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

10

ReUnite® Small Screws Fixation SystemHallux Valgus Correction

Insertion of the Nail (optional)If deemed appropriate, a nail can be inserted for minimal correction. A 2.0 mm x 14 mm nail is commonly used. To insert the nail seat the inserter against the soft tissue and drive a 2.0 mm guidewire into the bone to the selected length. Read the depth marking off the guidewire to deter-mine the size of the nail.

Note: When between sizes, move down in length.

Remove the guidewire and insert the measured length of the LactoNail® implant in the inserter (Figure 16) and tap the plunger with a mallet until it is seated against the inserter (Figures 17/17A).

Removal of Excess BoneAfter insertion of the nail, use the sagittal saw blade to resect any excess bone on the shaft of the first metatarsal (Figure 18).

Figure 17

Figure 17A

Figure 16 Figure 18

Page 11: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

11

ClosureThe capsule and subcutaneous tissue are closed with 3-0 monocryl. During capsular closure the toe is held in slight plantarflexion to allow for better toe purchase. The skin is closed with 5-0 monocryl subcuticular closure. Suture material varies based on surgeon preference (Figure 19).

Post-Op ProtocolThe patient can weight bear with surgical shoe or CAM walker immediately. Depending on swelling, shoe is worn for 4 weeks. The patient is then allowed to progress to sneakers. Physical strenuous activity is typically allowed at 8 weeks.

Figure 19

Page 12: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Product Part Number Description Size948490 2.0 mm Solid, Full Thread Orthopedic Screws 5 mm

948491 2.0 mm Solid, Full Thread Orthopedic Screws 7 mm

948492 2.0 mm Solid, Full Thread Orthopedic Screws 9 mm

948493 2.0 mm Solid, Full Thread Orthopedic Screws 11 mm

948494 2.0 mm Solid, Full Thread Orthopedic Screws 13 mm

948495 2.0 mm Solid, Full Thread Orthopedic Screws 15 mm

948496 2.0 mm Solid, Full Thread Orthopedic Screws 17 mm

948500 2.5 mm Solid, Full Thread Orthopedic Screws 5 mm

948501 2.5 mm Solid, Full Thread Orthopedic Screws 7 mm

948502 2.5 mm Solid, Full Thread Orthopedic Screws 9 mm

948503 2.5 mm Solid, Full Thread Orthopedic Screws 11 mm

948504 2.5 mm Solid, Full Thread Orthopedic Screws 13 mm

948505 2.5 mm Solid, Full Thread Orthopedic Screws 15 mm

948506 2.5 mm Solid, Full Thread Orthopedic Screws 17 mm

948507 2.5 mm Solid, Full Thread Orthopedic Screws 19 mm

948508 2.5 mm Solid, Full Thread Orthopedic Screws 21 mm

948509 2.5 mm Solid, Full Thread Orthopedic Screws 23 mm

948510 2.5 mm Solid, Full Thread Orthopedic Screws 25 mm

948511 2.5 mm Solid, Full Thread Orthopedic Screws 27 mm

948100 2.8 mm Solid, Full Thread Orthopedic Screws 11 mm

948101 2.8 mm Solid, Full Thread Orthopedic Screws 13 mm

948102 2.8 mm Solid, Full Thread Orthopedic Screws 15 mm

948103 2.8 mm Solid, Full Thread Orthopedic Screws 17 mm

948104 2.8 mm Solid, Full Thread Orthopedic Screws 19 mm

948105 2.8 mm Solid, Full Thread Orthopedic Screws 21 mm

948106 2.8 mm Solid, Full Thread Orthopedic Screws 23 mm

948107 2.8 mm Solid, Full Thread Orthopedic Screws 25 mm

948108 2.8 mm Solid, Full Thread Orthopedic Screws 27 mm

948109 2.8 mm Solid, Full Thread Orthopedic Screws 29 mm

948110 2.8 mm Solid, Full Thread Orthopedic Screws 31 mm

948111 2.8 mm Solid, Full Thread Orthopedic Screws 33 mm

Implants

Nom

inal

Len

gth

ReUnite® Small Screws Fixation System

Page 13: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Product Part Number Description Size950047 Resorbable Small Screwdriver N/A

950048 Modular Handle/Tap Handle N/A

950049 Direct Head Driver N/A

950086 Drill Bit Sterile 1.7 mm

950087 Drill Bit Sterile 2.2 mm

950050 Drill Bit Non-Sterile 1.7 mm

950051 Drill Bit Non-Sterile 2.2 mm

950114 Overdrill 2.5 mm

950107 Overdrill 2.8 mm

950101 Tap Sterile 2.0 mm

950102 Tap Sterile 2.5 mm

950103 Tap Sterile 2.8 mm

950053 Tap 2.0 mm

950054 Tap 2.5 mm

950083 Drill/Tap Guide N/A

950056 Drill Sleeve 1.7 mm

950057 Drill Sleeve 2.2 mm

950060 Tap Sleeve 2.0/2.5 mm

950061 Tap Sleeve 2.8 mm

950070 Depth Gauge N/A

950078 Instrumentation Case N/A

Instruments

Page 14: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Product Part Number Description Size948900 LactoNail® Bone Fixation 1.6 mm x 14 mm

948902 LactoNail® Bone Fixation 1.6 mm x 18 mm

948904 LactoNail® Bone Fixation 1.6 mm x 22 mm

948906 LactoNail® Bone Fixation 1.6 mm x 26 mm

948910 LactoNail® Bone Fixation 2.0 mm x 14 mm

948912 LactoNail® Bone Fixation 2.0 mm x 18 mm

948914 LactoNail® Bone Fixation 2.0 mm x 22 mm

948916 LactoNail® Bone Fixation 2.0 mm x 26 mm

Product Part Number Description Size948950 Steinmannn Pin/K-wire Depth Gauge 1.6 mm Sterile

948951 Steinmannn Pin/K-wire Depth Gauge 2.0 mm Sterile

948954 Single Ended K-wire (pkg. 6) 1.5 mm

948940 Inserter N/A

948943 Guide Tip 1.6/2.0 mm

948945 Plunger 1.6/2.0 mm

995154 Instrument Case Tray N/A

995150 Instrument Case Lid N/A

Implants

Instruments

LactoNail® Bone Fixation

Page 15: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

Indications for Use and Contraindications for Use for the ReUnite® Small Screw Fixation System are as follows:

INDICATIONS

1. The LactoSorb™ Hand System is indicated for surgical fixation of closed non- comminuted diaphyseal fractures in the presence of appropriate immobilization.

2. The LactoSorb™ 5.0 mm Washer is used in conjunction with the Biomet Sports Medicine™ 5.0 mm Bone Screw for ankle fractures, metatarsal fusion, and metatarsal osteotomies (Hallux Valgus) in the presence of appropriate protection or immobilization (e.g. casting, bracing, external fixator etc.).

3. The 2.0 mm, 2.5 mm and 3.5 mm Resorbable Bone Screws, and Resorbable Bone Pins, are indicated for use in the presence of appropriate immobilization in the following procedures: correction of Hallux Valgus (bunion) and repair of metacarpal and phalangeal fusion and fractures.

4. The resorbable mesh, sheets, 2.5 mm and 3.5 mm screws, and 2.5 mm rivets are indicated for maintaining the position of bony fragments or morselized bone graft in iliac crest autograft procedures. The LactoSorb™ devices are not intended for use in spine or joint space. This product is not intended for pelvic fracture fixation.

5. The Resorbable Hammer Toe Pin is a resorbable device used for proximal interphalangeal joint (PIP) arthrodesis.

6. The LactoNail™ Bone Fixation is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. Examples include the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

CONTRAINDICATIONS

1. Active Infection.

2. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

3. Patient conditions including, blood supply limitations, obesity, insufficient quantity or quality of bone stock or latent infection.

4. Do not use in load bearing procedures (excluding 5.0 screws and Hammer Toe Pins, see above indications).

5. Do not use LactoNail™ Bone Fixation for fractures and osteotomies of weight bearing cortical bone (except cortical bones of the foot and the hand).

6. Do not use LactoNail™ Bone Fixation for fractures and osteotomies in weight bearing cancellous bone.

7. Do not use LactoNail™ Bone Fixation in the treatment of physeal fractures in children.

For product information, including Indications for Use, Contraindications, Warnings, Precautions and Possible Adverse Effects, see the Patient Risk Information at Biomet.com.

Page 16: Surgical Technique - Shoulder€¦ · This brochure represents the surgical technique and post-op protocol utilized by Dr. Dmitry Sandler, DPM. Biomet, as the manufacturer, does not

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless other-wise indicated.

This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.

For additional product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert at Biomet’s website.

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 x 1501 ©2012 Biomet Sports Medicine • biomet.com

Form No. BSM0306.0 • REV041512

SPORTS MEDICINE