1.5mm Bone Fixation Kit Ref BXSxxxx Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE

1.5 mm Bone Fixation Kit FOR FRACTURE FIXATION OF NON-LOAD-BEARING BONES REF

Description

BXS6114

1 - 1.5 mm x 14 mm SmartNail, 1 Piston (PS6015), 1 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6116

1 - 1.5 mm x 16 mm SmartNail, 1 Piston (PS6015), 1 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6118

1 - 1.5 mm x 18 mm SmartNail, 1 Piston (PS6015), 1 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6120

1 - 1.5 mm x 20 mm SmartNail, 1 Piston (PS6015), 1 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6125

1 - 1.5 mm x 25 mm SmartNail, 1 Piston (PS6015), 1 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6214

2 - 1.5 mm x 14 mm SmartNail, 1 Piston (PS6015), 2 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6216

2 - 1.5 mm x 16 mm SmartNail, 1 Piston (PS6015), 2 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6218

2 - 1.5 mm x 18 mm SmartNail, 1 Piston (PS6015), 2 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6220

2 - 1.5 mm x 20 mm SmartNail, 1 Piston (PS6015), 2 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000).

BXS6225

2 - 1.5 mm x 25 mm SmartNail, 1 Piston (PS6015), 2 Insertion Sheath (SH6015) and 1 - 1.5 mm K- Wire (BXS6000). 1

DESCRIPTION Each Bone Fixation Kit consists of one or two 1.5mm SmartNail® implants with lengths of either 14mm, 16mm, 18mm, 20mm or 25mm, as well as the disposable, sterile, single use instruments necessary to insert the SmartNail® implants – insertion piston, insertion sheath, K-Wire (packaged separately). The SmartNail® implant is constructed of Self-Reinforced™ (SR) polylactide copolymer material. The manufacturing process provides high initial mechanical strength and stiffness of the nails for insertion through the healing phase (approximately 12 weeks). Properly used, in the presence of adequate immobilization, SmartNail® implants maintain correct realignment and allow secure fixation until clinical determination of healing of a fracture or corrective osteotomy. As the fractured or osteotomized bone gains strength during healing, the SmartNail® implant gradually loses its strength. Absorption follows strength loss and is completed within several years, depending also on patient variables. SmartNail® implants are Latex Free products. MATERIALS AND SPECIFICATIONS Implant Materials: Self-Reinforced™ Polylactide Copolymer (SR-96L/4D PLA cop) Instrument Materials: K-Wire, Piston, Insertion Sheath – Stainless Steel INTENDED USE/INDICATIONS FOR USE The 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate brace and / or immobilization. CONTRAINDICATIONS 1. Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand). 2. Fractures and osteotomies in weight bearing cancellous bone. 3. Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed. 4. Treatment of physical fractures in children, because the effect of SmartNail® implants upon the healing of growth plates has not been tested clinically. 5. Patients with suspected or known allergy to the implant materials.

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WARNINGS 1. Until healing is complete, all fixation achieved with this device should be considered as only temporary and may not withstand weight-bearing or other unsupported stress. Premature bending, loosening, fracture or migration of the nails may result from early stress and activity. Appropriate immobilization/ controlled mobilization should be used until clinical determination of healing. 2. Transient local fluid accumulation and/or sinus formation may occur, but very seldom, in sterile circumstances. Aspiration (simple drainage) may yield implant remnants and usually results in healing of the sinuses without adverse effect to fracture healing. 3. Sterility and Handling: The 1.5 mm Bone Fixation Kit has been sterilized with gamma radiation (SAL 10-6). Removal from the sterile package using aseptic techniques should only take place after the correct size of nail has been determined immediately before use. 4. The SmartNail® implant and Bone Fixation Kit Instrumentation MUST 2 NOT BE RESTERILIZED BY ANY METHOD. Single use only. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and / or sterility of the device. 5. The kit is sterile if the package is not damaged. Discard open, unused nails and instruments. 6. Do not use the kit beyond the expiration date on the label. The performance,safety, and/or sterility of the device cannot be assured beyond the expiration date. 7. Do not store SmartNail® implants in temperatures exceeding 40°C 40° C (104°F). The implant may not retain the proper shape with exposure to 104° F excessive heat. 8. A surgeon must give the patient appropriate instructions for post-operative care and rehabilitation in order to prevent premature load bearing and other complications. 9. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the nail are important considerations in the successful utilization of this device. Surgeons must choose the proper nail size based on specific procedure and patient history. 10. Improper insertion technique may cause breakage of the nail or premature failure. 11. Patients should be advised that product materials may cause allergic reactions including but not limited to foreign body reactions, tissue irritation/inflammation or other allergic STERILIZE

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reactions. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. 12. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure. Nail removal should be followed by adequate postoperative management. PRECAUTIONS 1. The SmartNail® implant should only be used with the designated surgical instruments as outlined above. 2. Postoperative or Intraoperative Cutting of Nails: SmartNail® implants must not be cut by any method. 3. The SmartNail® implant has not been evaluated for safety and compatibility in the MRI environment. The SmartNail® implant has not been tested for heating or migration in the MRI environment. ADVERSE EVENTS 1. Infections, both deep and superficial. 2. Allergies, tissue irritation/inflammation and other reactions to implant and/or instrument materials. 3. Transient local fluid accumulation or sinus formation, arthritis pain or deformity and stiffness. INSTRUCTIONS FOR USE/SURGICAL TECHNIQUE As with other methods of internal fixation: • Proper local, regional or general anaesthesia • Aseptic conditions • Proper exposure • X-ray control • Perioperative antibiotics are recommended.

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1. 2. 3. 4. 5.

The fragment is reduced through standard techniques. The 1.5 mm K-Wire (BXS6000) is drilled into the bone up to the corresponding laser line indicating length of the implant. The K-Wire is removed. The Insertion Sheath (SH6015) containing the appropriate length SmartNail® implant is placed over the drilled hole and the piston (PS6015) is used to advance the SmartNail® implant until it is fully seated. A small mallet should be used to advance the piston, until the implant is fully seated and penetrated totally beneath the surface of the tissue. The procedure would be repeated if using two SmartNail® implants. Once adequate and stable fixation has been achieved, the wound is closed and dressing is applied using standard principles of orthopedics and traumatology. Standard post-operative care protocols should be followed.

PACKAGING AND LABELING

Upon initial receipt of the product, this device should only be used if original packaging and labeling are intact. If packaging has been opened or altered, contact your local ConMed Linvatec sales representative, or in the U.S., contact the Customer Service Department. INFORMATION For more information or a product demonstration, contact your regional ConMed Linvatec sales representative.

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FRANÇAIS/MODE D’EMPLOI

1.5 mm Bone Fixation Kit POUR LA FIXATION DES OS NON PORTEURS RÉF.

Description

BXS6114

1 - SmartNail 1,5 mm x 14 mm, 1 piston (PS6015), 1 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6116

1 - SmartNail 1,5 mm x 16 mm, 1 piston (PS6015), 1 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6118

1 - SmartNail 1,5 mm x 18 mm, 1 piston (PS6015), 1 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6120

1 - SmartNail 1,5 mm x 20 mm, 1 piston (PS6015), 1 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6125

1 - SmartNail 1,5 mm x 25 mm, 1 piston (PS6015), 1 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6214

2 - SmartNail 1,5 mm x 14 mm, 1 piston (PS6015), 2 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6216

2 - SmartNail 1,5 mm x 16 mm, 1 piston (PS6015), 2 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6218

2 - SmartNail 1,5 mm x 18 mm, 1 piston (PS6015), 2 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6220

2 - SmartNail 1,5 mm x 20 mm, 1 piston (PS6015), 2 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

BXS6225

2 - SmartNail 1,5 mm x 25 mm, 1 piston (PS6015), 2 gaine d'insertion (SH6015) et 1 broche de Kirschner de 1,5mm (BXS6000).

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2797 EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany STERILE

40° C 104° F

ConMed Corporation 525 French Road Utica, NY 13502-5994 USA Phone: (727) 392-6464 Customer Service: 1-800-237-0169 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com ©2011, 2012, 2013 ConMed Corporation. All rights reserved. P000015885 Rev A

10/2019