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Femoral Reconstruction Nail Specification, Uses, Sizes and Surgical Techniques

Femoral Reconstruction Nail is designed to help treat various fractures of the femur. Different nails are available to be placed through the tip of the Greater Trochanter. Screws are placed through the nail to secure the implant in place and maintain length and alignment while healing occurs. The nails have multiple screw holes in the proximal body to allow surgeons to address different fracture types. Proximal and distal slots allow for compression or dynamization across a fracture.

Femoral Reconstruction nail

Femoral Reconstruction Nail Introduction

Femoral Reconstruction Nail System offers an extensive range of surgical entry points and locking options to meet more surgeons’ needs for femoral shaft fractures.

Designed for anatomical fit

Nail designed to better fit patient anatomy and help avoid impinging anterior cortex compared to nails with a larger radius of curvature.

Reduced procedural complexity

Femoral Reconstruction Nail instrumentation includes features designed to reduce surgical complexity facilitating intraoperative visualization, implant positioning and alignment as well as ease of use for OR staff.

Proximal locking options

Choice of standard and reconstruction locking modes allows for the treatment of a variety of femoral fracture patterns and locations.

Distal locking options

Equipped with four distal locking options, including an oblique distal hole to better target bone in the condyles and an A/P hole that provides an optional purchase point.

Entry point selection

Greater Trochanter and Piriformis Fossa entry point nail designs to accommodate varying patient anatomies and surgeon preference.

Femoral Reconstruction Nail Specification

Advanced nail design

  • Femoral Reconstruction Nail design offers great flexibility
  • Different Nails for left and right femur
  • Anatomic bend for ease in insertion and extraction
  • Cannulation of all nails for guided insertion in reamed and unreamed technique
  • Large portfolio with nail diameters ranging from Dia 9 to 14 mm and lengths ranging from 280 to 460 mm
  • Versatile locking configuration for static, dynamic and standard locking
  • Femoral Reconstruction Nail available in Titanium and SS 316L

Unique distal locking options

The unique distal combination hole enables the optimal locking for every anatomical situation and fracture type. The surgeon can use standard locking (with two locking screws). The end cap allows for angular stable locking of the most distal locking implant in both configurations.

End caps

  • Self-retaining Screw driver for effortless and secure end cap pick-up and insertion
  • Possibility to block most proximal locking screw  for absolute angular stability
  • End cap prevents ingrowth of tissue and facilitates nail removal

Locking screws

  • The 6.4 mm Cannulated Lag Screws have a unique thread design that provide an excellent grip. Improved front cutting flutes allow for lesser insertion torque and thinner flanks for less bone removal.
  • Secure placement of the Lag Screws within small neck diameters can be achieved due to separating the two 6.4 mm lag screws and distance between the 6.4 mm Lag screws.
  • The distal locking configuration features a round and an oblong hole to allow for static and / or dynamic distal locking.
  • 5 mm cortical screws, common to the Femoral Reconstruction Nails, are designed to simplify the surgical procedure and promote a minimally invasive approach.
  • Self-holding Screw driver for effortless and secure locking screw pick-up.
  • Double thread for more contact points leading to enhanced stability
  • Larger cross-section for improved mechanical resistance
  • Thread closer to screw head providing better bone purchase and improved stability
  • Self-holding Screw driver for effortless and secure locking screw pick-up

Femoral Reconstruction Nail Uses

Femoral Reconstruction Nail System is intended for treatment of fractures in adults and adolescents in which the growth plates have fused. Specifically, the system is indicated for:

  • Subtrochanteric fractures
  • Ipsilateral neck/shaft fractures
  • Femoral shaft fractures
  • Impending pathologic fractures
  • Malunions and nonunions

Femoral Reconstruction Nail Uses

Femoral Reconstruction Nail Contraindications

The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

  • Any active or suspected latent infection or marked local inflammation in or about the affected area.
  • Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
  • Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.
  • Material sensitivity, documented or suspected.
  • Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to
    failure of the device itself.
  • Patients having inadequate tissue coverage over the operative site.
  • Implant utilization that would interfere with anatomical structures or physiological performance.
  • Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
  • Other medical or surgical conditions which would preclude the potential benefit of surgery.

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What is a femoral shaft fracture?

A femoral shaft fracture is a break of the femur (thighbone). Femoral nailing is an operation to fix a broken femur using a metal rod. The metal rod is called a femoral nail (also called an intramedullary or interlocking nail)

Your surgeon has recommended femoral nailing to treat your broken femur. However, it is your decision to go ahead with the operation or not. This document will give you information about the benefits and risks to help you make an informed decision. If you have any questions that this
document does not answer, you should ask your surgeon or any member of the healthcare team.

How does a femoral shaft fracture happen?

Road accidents and sport are the cause of most femoral shaft fractures. You can lose up to a litre (about two pints) of blood into the thigh muscle at the time of the injury. Sometimes the injury causes the bone to break through the skin. This is known as an open or compound fracture.

What are the benefits of surgery?

The main benefits of surgery are that you will only need a short stay in hospital and you will be able to use your leg sooner. Surgery will also make sure your bone heals in a good position.

Are there any alternatives to femoral nailing?

A femoral shaft fracture can be treated in traction (using a heavy weight fixed to the leg to pull the bones into position until they heal). However, some fractures are difficult to hold in a good position without surgery. If you have an open fracture, you will almost certainly need an operation. Your surgeon can sometimes fix your femoral shaft fracture with an external fixator or a plate and screws instead of a femoral nail. They will explain why they recommend femoral nailing for your fracture.

What will happen if I decide not to have the operation?

You will have your leg in traction. You may need to stay in hospital for a long time. This can lead to complications such as blood clots, chest infection and pressure sores. After a number of weeks, your leg may be put into a large plaster cast (called a hip spica) or a brace. The fracture will take about three to six months to heal. You will need physiotherapy to learn to walk again because your muscles will have become weak after spending such a long time in bed.

What does the operation involve?

The healthcare team will carry out a number of checks to make sure you have the operation you came in for and on the correct side. You can help by confirming to your surgeon and the healthcare team your name and the operation you are having.

A variety of anaesthetic techniques is possible. Your anaesthetist will discuss the options with you and recommend the best form of anaesthesia for you. You may also have injections of local anaesthetic to help with the pain after surgery. You may be given antibiotics during the operation to reduce the risk of infection. The operation usually takes between an hour and an hour and a half.

Your surgeon will push the femoral nail down the inside of the bone, either through a cut on the side of the hip or on the front of the knee. The nail goes across the break and holds it in position. The nail is held in the bone by locking screws that pass through holes in the nail. If you have an open fracture, your surgeon will clean the skin wound thoroughly during the operation to reduce the risk of infection. If the skin is badly damaged, you may also need one or more plastic surgery operations. At the end of the operation, your surgeon will close the skin with stitches or clips.

What should I do about my medication?

You should let your doctor know about all the medication you are on and follow their advice. This includes herbal remedies and medication to control diabetes and blood pressure. If you are on beta-blockers, you should continue to take them as normal. You may need to stop taking warfarin or clopidogrel before your operation. Anti-inflammatory painkillers may stop the fracture healing properly, so it is better not to
take these if possible.

What can I do to help make the operation a success?

If you smoke, stopping smoking may reduce your chances of getting complications and will improve your long-term health. Nicotine is known to stop fractures from healing. Regular exercise should help you recover and improve your long-term health. Before you start exercising, ask a member of the healthcare team or your GP for advice. You can reduce your risk of infection in a surgical wound by keeping warm around the time of your operation. Let a member of the healthcare team know if you are cold.

Warnings and Precautionary for Femoral Reconstruction Nail

Before using Femoral Reconstruction Nail, the surgeon and ancillary staff should study the safety information in these instructions, as well as any product-specific information in the product description, surgical procedures and/or brochures.

Femoral Reconstruction Nail is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Nails assure best working results provided they are used in the proper manner. Therefore, the following instructions for use and safety recommendations must be observed.

Improper use of  Nails can lead to damage to the tissue, premature wear, destruction of the instruments and injury to the operator, patients or other persons.

It is vital for the operating surgeon to take an active role in the medical management of their patients. The surgeon should thoroughly understand all aspects of the surgical procedure and instruments including their limitations. Care in appropriate selection and proper use of surgical instruments is the responsibility of the surgeon and the surgical team. Adequate surgical training should be completed before use of implants.

Factors which could impair the success of the operation:

  • Allergies to implanted materials.
  • Localized bone tumours.
  • Osteoporosis or osteomalacia.
  • System disease and metabolic disturbances.
  • Alcohol and drug abuse.
  • Physical activities involving excessive shocks, whereby the implant is exposed to blows and/or excessive loading.
  • Patients who are mentally unable to understand and comply with the doctor’s instructions.
  • Poor general health.

Possible Adverse Effects

The following adverse effects are the most common resulting from implantation:

  • Loosening of the implants, which may result from cyclic loading of the fixation site and/or tissue reaction of the implant.
  • Early and late infection.
  • Further bone fracture resulting from unusual stress or weakened bone substance.
  • Temporary or chronic neural damage resulting from pressure or hematomata.
  • Wound hematomas and delayed wound healing.
  • Vascular disease including venal thrombosis, pulmonary embolism and cardiac arrest.
  • Heterotopic ossification.
  • Pain and discomfort due to presence of the Femoral Reconstruction Nail.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for Femoral Reconstruction Nail

The operating planning is carried out following a thorough clinical evaluation of the patient, Also, x-rays must be taken to allow a clear indication of the bony anatomy and associated deformities. At the time of the operation, the corresponding implantation instruments in addition to a complete size of Femoral Reconstruction Nail must be available.

The clinician should discuss with the patient the possible risks and complications associated with the use of implants. It is important to determine pre-operatively whether the patient is allergic to any of the implant materials. Also, the patient needs to be informed that the performance of the device cannot be guaranteed as complications can affect the life expectancy of the device.

Femoral Reconstruction Nail Precautions

  • Confirm functionality of instruments and check for wear during reprocessing. Replace worn or damaged instruments prior to use.
  • It is recommended to use the instruments identified for this Nails.
  • Handle devices with care and dispose worn bone cutting instruments in a sharps container.
  • Always irrigate and apply suction for removal of debris potentially generated during implantation or removal.

Femoral Reconstruction Nail Warnings

  • Femoral Reconstruction Nail can break during use (when subjected to excessive forces). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail.
  • Instruments, screws and cut plates may have sharp edges or moving joints that may pinch or tear user’s glove or skin.
  • Take care to remove all fragments that are not fixated during the surgery.
  • While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Nails removal should be followed by adequate post-operative management to avoid refracture.

Femoral Reconstruction Nail General Adverse Events

As with all major surgical procedures, risks, side effects and adverse events can occur. While many possible reactions may occur, some of the most common include: Problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues incl. swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hypersensitivity reactions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the Femoral Reconstruction Nail, reoperation.

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