MINIBunion 3D Minimally Invasive Bunion System

The MiniBunion® System implants and instruments are provided sterile or nonsterile to the end user. Sterile packaging and components should be inspected to ensure there is no damage. If the packaging or implants’ integrity has been compromised use an alternate item and contact the manufacturer for further instructions. Implants are for single use only. A single use device (SUD) that comes into contact with human blood or tissue should not be re-used and should be returned to the manufacturer or properly disposed.
 
All components of the MiniBunion® System are provided sterile for single use only or non-sterile.
Inspect the sterile packaging used for the implants and instruments prior to use. If the packaging and/or seal is damaged, sterilization may be compromised, and the implant and/or instrument should not be used.

The MiniBunion® Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

Contraindications for the MiniBunion® System are as follows:

• Comminuted bone surface that would prevent proper implant placement
• Pathological bone conditions that would prevent secure implant fixation
• Acute or chronic infections local or systemic
• Physiological or psychological conditions that limit the patient’s ability and/or willingness to follow instructions during the healing process.
• Inadequate skin, bone, or neurovascular status
• Known allergies or sensitivity to metals, including titanium and nickel.

 
Contraindications may be relative or absolute and are left to the discretion of the surgeon.

• Surgeon familiarity with the device, instrumentation, and surgical technique prior to surgery is crucial to proper device installation.
• As with any implant system, the implants cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight-bearing or load-bearing in the presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using routine methods be maintained until bone healing has occurred.
• Reduction of the site should be achieved and maintained prior to implanting the device. The implant is only intended to provide a buttress for the healthy bone during the healing process. • If it is suspected that sterilization is compromised prior to implantation, another sterile implant should be used. Product should not be re-sterilized.
• A single use device (SUD) that comes into contact with human blood or tissue should not be re-used and should be returned to the manufacturer or properly disposed

Following the instructions for use provided in product literature can minimize the potential for complications or adverse reactions with any implant. It is the responsibility of each surgeon using implants to consider the clinical and medical status of each patient and to be knowledgeable about all aspects of implant procedure and the potential complications that may occur. The benefits derived from implant surgery may not meet the patient’s expectations or may deteriorate with time, necessitating revision surgery to replace the implant or to carry out alternative procedures. Revision surgeries with implants are common. The patient’s mental status must also be considered. Willingness and/or ability to follow postoperative instructions may also impact the surgical outcome. Surgeons must balance many considerations to achieve the best result in individual patients. IF EXCESSIVE LOADING CANNOT BE PREVENTED, AN IMPLANT SHOULD NOT BE USED. The main goal of surgery with this implant is to establish a buttress for stability of healthy bone during the healing process.
 
Abnormal or excessive forces could lead to delayed failure of the implant and suture construct. Abnormal force loading and subsequent wear may be caused by:

• Uncorrected instability
• Improperly sized implant
• Inadequate soft tissue support
• Implant malposition
• Excessive motion
• Uncorrected or recurrent deformity
• Patient misuse or over activity 

Proper fixation at the time of surgery is critical to the success of the procedure. Bone stock must be adequate to support the device. Some preventative measures to consider in order to minimize the potential for complications:
Follow guidelines for indications and contraindications provided below

• Identify prior pathology
• Stabilize collapsed deformities
• Bone graft pre-existing cysts
• Use a properly sized implant

 
Avoid flawing implant surfaces to minimize the potential for early fatigue failure. If complications develop, possible corrective procedures include:

• Implant removal
• Bone grafting of cysts
• Replacement of the implant 

Over time, implants may loosen, fracture, or cause pain after soft tissue is healed. Removal of implants is at the surgeon’s discretion, and the appropriateness of the selected procedure will be based on the surgeon’s personal medical training and experience. It is imperative that adequate postoperative care and protection be provided by the surgeon.

In any surgical procedure, the potential for complications exists. Surgical procedures involving these devices should not be attempted by physicians unfamiliar with possible adverse clinical events which may occur during or after the procedure and could require additional surgery for implant revision. The risks and complications with this system include:

• Failure or breakage of the implant or part of the implant
• Infection or painful, swollen, or inflamed implant site
• Loosening or dislocation of the implant requiring revision surgery
• Bone resorption or overproduction
• Allergic reaction(s) to implant material(s)
• Untoward histological responses possibly involving macrophages and/or fibroblasts
• Migration of particle wear debris possibly resulting in a bodily response
• Damage to nerves and vessels
• Delayed union or malunion; prolonged healing
• Edema
• Muscle tendon impalement and excessive operative bleeding
• Nonunion pseudoarthrosis development and persistence and failure of the bone regenerating satisfactorily
• Venous thrombosis, pulmonary embolism, cardiovascular problems
• Inability to compress the bone surface due to poorly fixated implant

 
The anticipated adverse device effects are the same as those associated with the currently available fixation procedures. No additional risks are associated with the MiniBunion® System.