Indications & General Knowledge 1

ClearView Top & Side Diagrams 2

Features & Benefits 2

Aligning the Clearview™ 3

Skin Incisions 3

Inserting 3mm Half Pins 4

Trimming & Locking Half Pins 5

Adjusting the ClearView™ 5

Distracting the Fixator 6

Finishing & Final Check 6

Fixator Removel 7

Components of the ClearView 8

Table of Contents

Indications for use. The ClearView™ wrist fixation system is indicated for treatment of a variety of distal radius fractures.

• Unstable fracture of the distal radius

• Fracture dislocation of the wrist

• Open fractures, forearm and wrist

• Fractures of the distal radius requiring distraction

• Colles Fractures

• Fracture dislocation with ligamentos instability

• Comminuted intra-articular radius fractures

• Post traumatic reconstruction for joint stiffness

• Distal Radius Fractures (Type B & C)

• Frykman type III & IV radius fractures

• Frykman type VII & VIII radius fractures

Contraindications. Do not use the ClearView™ system if the following occurs:

• Osteoporosis, insufficient bone quality

• Mental/noncompliant patient unable or unwilling to follow postoperative instruction

• Presence of Sepsis, active or latent Infection

• Severely comminuted fractures

• Any fracture where as rigid fixation or reduction cannot be achieved by means of external fixation

Preoperative. Treating surgeon should review the following recommendations prior to fixator application:

• The surgeon should be familiar with alternative fracture management of distal radius and wrist fractures.

• The surgeon should be familiar with the system and its various components before their use, and should personally assemble the fixator to verify that all component parts and necessary instruments are present before surgery.

• Physicians are strongly encouraged to study the surgical technique, which contains specific instructions and application notes regarding proper use of the device.

• Patient selection should be in accordance with the listed indications and contraindications.

• Patient should be informed of rationale, use and potential compliance of the ClearView™ System.

Possible adverse effects. Treating surgeon should advise patients of the following possible adverse effects:

• Damage to vessels, nerves and/or soft tissues caused by insertion or presence of skeletal pins.

• Damage to ligaments, tendons or other soft tissues caused by improper use of the device.

• Tissue necrosis during pin insertion.

• Superficial or deep pin track infection.

• Foreign body reaction to the pins, which are made of implant grade stainless steel containing nickel and other ingredients.

• Loosening or breakage of skeletal pins.

• Necessity for reoperation to replace a skeletal pin or the entire device.

• Pressure necrosis at the pin-tissue junction.

• Skin pressure problems caused by external fixator components.

• Excessive operative bleeding.

• Septic arthritis and osteomyelitis

• Persistent drainage after pin removal; chronic pin-site osteomyelitis

• The intrinsic risks associated with anesthesia.

• Inadvertent injury to the patient or operating room personnel caused by pin cutting during surgery.

Warnings and precautions. For safe and effective use, the surgeon should be familiar with the fixator device, method of application, instruments, and recommended surgical technique;

• This device is not intended to withstand the stress of weight bearing, load bearing, or excessive activity.

• Device breakage, damage, or malfunction can occur whn the implant is subject increased loading associated with delayed union, nonunion, or improper use.

• Improper insertion of the device can increase the possibility of loosening, breakage, and nonunion.

• This device is intended for single use only and should be used in conjunction with recommended procedures and techniques.

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ClearView™ Top & Side Diagrams

Construction & material. Made of lightweight, optically clear, radiolucent polycarbonate material • Polymer is designed specifi cally for Eto, steam and gamma sterilization. • Radio-lucent feature provides a clear unobstructed radiographic view of the trauma area while providing rigid and stable fi xation.

Simple application. The wrist fi xator is easier to apply than competing devices. Two small alignment beads — top and side — remove the guesswork as to where the fi xator should be positioned on the patient.

Translucent and radiolucent. The wrist fi xator is translucent and radiolucent, giving the operating surgeon an unobstructed view of the trauma area, regardless of the viewing angle — AP, oblique, or lateral. • Two alignment beads and half pins are the only elements visible on an x-ray.

Pin holder socket and assembly. Ball & pin holder assembly enables 3mm pins to be inserted and fi xed within a variable 40-degree arc for best possible placement. • Simple locking caps enable pins to be locked and unlocked quickly and easily, providing greater fl exibility throughout the surgical procedure.

Intraoffi ce adjustment. The ClearView™ wrist fi xator allows the surgeon to easily perform intraoperative and intraoffi ce distraction and adjustments.

And all the above enable the patient to quickly resume everyday tasks such as donning clothing and performing simple hygiene, “luxuries” that traditional, more cumbersome fi xation devices simply do not allow.

Features & Benefi ts

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Aligning the ClearView™Under appropriate anesthesia and with the patient in the supine position, properly drape the eff ected extremity and apply horizontal fi nger trap traction. Place the ClearView™ fi xator so that the AP alignment bead is over the distal aspect of the radial articular suface. Correct placement can be achieved though intraoperative image intensifi cation or palpation of the joint. Position the fi xator so that pin hole one (1) is aligned with the fi rst metacarpal and pin hole six (6) with the medial radial shaft. Using the skin marker provided, indicate the incision sites for half pins one (1) and six (6). Also mark any additional pin sites to be utilized, keeping in mind that a minimum of two distal and two proximal half pins are requireda afor proper fi xation.

Skin IncisionsMake a longitudinal one centimeter incision at the indicated position of the index metacarpal. Proper blunt dissection technique should be utilized to protect the branches of the radial nerve while exposing the boney surface. Full visualization prevents unintentional pinning of the muscle-tendon units to the skeleton and improves pin placement accuracy.

Repeat the above step, this time exposing the radial boney surface at pin site six (6).

Finally, incise at least two additional sites at pin locations two (2) thru fi ve (5).

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Pin insertion. Using the 3mm half pin driver, insert the appropriately threaded 3mm half pin into hole one (1) and six (6). The half pin thread selection will depend on patient anatomy and should reflect the bone characteristics at the fi xator pin site holes after alignment; i.e., cortical or cancellous bone.

After inserting half pins one (1) and six (6), the fi xator’s position is established, leaving the surgeon’s hands relatively free to insert additional half pins until satisfactory fi xation is achieved.

Use image intensifi cation to verify pin placement and the bicortical penetration depth of all half-pins. Makeadjustments as necessary.

Close wounds loosley with interrupted sutures.

Inserting 3mm Half PinsPin selection. Three cortical 3mm half pins and three cancellous 3mm self-drilling half pins are enclosed with the ClearView™ system. All enclosed half pins are bicortical and self tapping.

Pilot Drilling. With the metacarpal and radius boney surfaces exposed, and the ClearView™ fi xator in position, use the 2.5mm Sticktite™ bit to drill a bicortical pilot hole at both the one (1) and six (6) half pin sites. The enclosed variable angle drill guide may be pivoted 40˚degrees in any angle within the fi xator socket for optimal bicortical purchase.

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Adjusting the ClearView™Medial lateral adjustment. The ClearView™ fi xator can be adjusted in the ML plane within a 75˚ range. The fi xator is shipped in the neutral position and can be rotated both 50˚ laterally and25˚ medially. To adjust the fi xator to the desired position,use the enclosed 7/64” hex allen wrench to remove theML translation locking screw. Determine rotationalalignment of the fracture through a physical comparison with the uninjured arm. Rotate the hand and fi xator into position and replace the locking set screw. Verify position with image intensifi cation. The set screw should be tightened using the two fi nger technique and routinely checked .

Anterior posterior adjustment. The fi xator can also be palmar-fl exed 75˚ in the AP plane. To adjust the fi xator to the desired position, use the enclosed 7/64” hex allen wrench to remove the AP translation locking screw. Determine rotational alignment of the fracture through a physical comparison with the uninjured arm. Palmer-fl ex the hand and fi xator into position and repeat the above steps for alignment verifi cation and locking the device.

Trimming & Locking Half PinsTrimming half pins. With half-pins in desired position, gently slide the fi xator so it touches the patient’s skin. Use a rotating motion to slide the half-pin sphere down the pin shaft into the fi xator socket. Spheres may off er resistance and be diffi cult to slide if pulled along the pin shaft without rotation. Using a pin cutter, trim the half-pins withinone-quarter inch of the fi xator surface.

Distance fi xator and lock half pins. Elevate the fi xator away from the skin surface establishing a distance of approximately one-quarter inch along the entire length of the fi xator,making certain that no part of the fi xator touches the patient’s skin.

Place locking caps over trimmed half-pin shafts and spheres and loosely thread into place. Use the enclosed box-ended wrench and two-fi nger tightening techniqueto lock the half-pin caps. (Care should be taken to ensurethe wrench sits squarely on the pin caps to avoidstripping or damaging the caps.)

Remove fi nger traction.

5

Distracting the FixatorUsing the 7/64” hex allen wrench (provided), engage the distraction set screw and turn clockwise to distract the wrist joint space. The distraction gauge on the ClearView indicates approximate distraction length. Gauge markings are 0, 2.5 mm, 5 mm, and 7.5 mm. The device is shipped in the neutral or 0 distraction position.

One revolution of the set screw will distract the joint 1/32 of an inch. Six revolutions is equivalent to approximately fi ve millimeters of distraction. Intraoperative radiographs should be taken to avoid over distraction of the wrist joint.

Finishing & Final CheckCheck both set screws. When tightening the AP & ML set screws, be sure to utilize the two fi nger technique. It’s important to note that the set screws act as locking pins to inhibit fi xator component rotation. Applying excessive torque in an attempt to further secure the fi xator’s translation angle may actually damage the device.

Check pin caps and fi xator distance. Make certain that the proper distance of approximately 5mm between the skin and fi xator have been maintained. Inspect the pin sites and relieve any pressure on the skin adjacent to the pins by extending the incisions as necessary.Once veri-fi ed, use the enclosed box-ended wrench and two-fi nger tightening technique (making certain the wrench sits squarely on the pin caps) to confi rm that all half-pin caps are securely locked. Remove and discard any half-pin caps from sockets in which half-pins have not been inserted.

Distraction. Confi rm that the fi xator is distracted to the desired distance by utilizing image intensifi cation. Any further adjustment to the distracted distance that is required to treat swelling, patient discomfort, and/or enhance the healing process can easily be accomplished during intraoffi ce visits.

NOTE: Overdistraction may lead to delayed fracture union and should be reduced or eliminated.

6

Fixator RemovalIntraoffice removal. The ClearView Fixator can typically be removed in the office without sedation, narcotics or local anesthesia. A careful explanation of the procedure to the patient, followed by gentle removal of the fixator and pins, produces minimal, if any, discomfort.

• Begin removal of the device by using the supplied double ended combo wrench to unthread the square drive pin caps covering the half pin ends on the proximal fixator plate (pins 4 thru 6).

• Remove the dorsal metacarpal square drive pin caps covering any additional pins (pins 1 thru 3).

• With the pin caps removed, the half pin spheres can now be rotated in an upwardly direction off the pin shaft. Spheres may offer resistance and be difficult to remove if pulled along the pin shaft without rotation.

• Press the fixator close to the patient’s arm to expose as much of the pin shaft as possible.

• Use a manual or variable speed power drill to rotate each pin slowly counterclockwise, taking care to minimize displacement of the soft tissues as the tip exits the bone.

• After removal of the half pins, the fixator body can also be removed.

• Administer appropriate wound care and therapy as needed.

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Cap & spheres

Instrumentation

3mm Half Pin Driver Combo Drill Guide/Cap Wrench

Components of the ClearView™ Wrist Fixation System

Fixator body

weight 3oz.

length 5.75 inches (146mm)

profile 1 inch

pin holes 6 – 3mm pin holes

dynamic 25mm

palmar 75˚ translation

Lateral 75˚ translation

radiolucent Yes

Sterilization. The ClearView is sterilized using gamma radiation and has been validated to a sterility assurance level (SAL) of 10-6.

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Additional components. • Skin marker• Hex allen wrench 7/64”• Disposable 6” rule• K-wires .045 gauge (2)• 2.5mm drill bit• Distraction set screw• Translation set screws (2)

• 3mm cortical half pins (3)• 3mm cancellous half pins (3)

Also enclosed with the ClearView™ System• Quick start guide• Surgical technique• Patient wound care CD/DVD

This Surgical Technique is intended for use with devices: Part number CV1215-00 and CV1217-00. All are intended for single use only. United States patent pending. Foreign patents applied for. Regulatory Class: II, 510(k) K020311. Surgial Technique part number 2215-2005.

The ClearView™ wrist fixator is intended for single use only. Item CV-1215 is delivered as a complete, sterile system. The mis-use, repeat use, alteration, or re-sterilization of this item is strictly prohibited and voids any and all warranties, subjecting user to the hold harmless and indemnification provisions below. DO NOT REUSE ClearView™ components. This product is deigned for single use applications only, and failure to comply with this provision may cause the ClearView™ to fail.

Original Sterilization: The ClearView™ labeled as CV-1215L/R, 1216L/R and 1217L/R is delivered sterile. The sterilization process is gamma radiation and has been validated to a sterility assurance level (SAL) of 10-6. If the sterile packaging is opened and the System not used for the case, discard the item and use a properly packaged item.

Disclaimer and Hold Harmless/Indemnification Agreement:The ClearView™ has been designed for single-use applications only. Re-sterilization or use by more than one patient is strictly prohibited. By purchasing and/or using this product, you agree to indemnify and hold Rigid Medical Technologies Corporation and its subsidiaries harmless from any claims, law suits, or other demands resulting from violation of the single-use application and prohibition of re-sterilization provisions, and from use of this product after discovery of any defect, abnormal handling, misuse or alteration of the product. Acceptance of this product constitutes your agreement to these terms.

© 2004 Rigid fx Orthopedics Corporation. All rights reserved. ClearView, the Rigid fx logo are trademarks of Rigid Medical Tech-nologies Corporation, registered in the U.S. and other countries. Printed in the U.S.

CAUTION: Federal law restricts this device to sale by or on the order of a Physician

Contact Information & Resources

Support for the ClearView™ System:

Telephone: (866) 562-9335 Web-based: www.rigidfx.com/support E-mail: info@rigidmedical.com

Ordering made quick & simple.

Telephone: (866) 562-9335On-line sales: www.store.rigidfx.comOrdering info: (866) 562-9335Fax: (866) 443-7771

For information on other Rigid fx products:

Telephone: (866) 562-9335Web-based: www.rigidfx.com/productsE-mail: info@rigidmedical.comOr write: Rigid fx Orthopedics Corporation 3601 South Congress Avenue Building B, Suite 300 Austin Texas 78704 USA

Billing Reference.

CPT 25611 Percutaneous skeletal fixation of distal radius fracture, with or without external fixation.CPT 25620 Open treatment of distal radius fracture, with or without internal or external fixation.CPT 20900 Bone graft, minor or small.CPT 20690 Application of a uniplane, unilateral external fixator system.CPT 20694 Removal of an external fixator under anesthesia.L6630 Stainless steel any wrist (per skeletal pin)L3982 Upper extremity fracture orthosis, radius/ulna, prefabricated, includes fitting/adjustment.L3984 Upper extremity fracture orthosis, wrist, prefabricated, includes fitting/adjustment.