PFN Nail (Proximal Femoral Nail) Specification, Uses, Sizes and Surgical Techniques

Proximal Femoral Nail

PFN Nail (Proximal Femoral Nail) Specification

  • Rotational stability: Combining a hip pin which provides rotational stability with a load-bearing femoral neck screw ensures intra- and postoperative safety.
  • Insertion safety stop: The screw shoulder prevents the femoral neck screw from undesired slippage through the nail into the femoral neck.
  • An anatomical angle of 6° allows the nail to be inserted and positioned in the medullary canal with ease.
  • PFN Nail (Proximal Femoral Nail) diameters of 9, 10, 11 and 12 mm permit insertion without reaming allowing a simplified, time saving surgical procedure with less blood loss.
  • A choice of static or dynamic interlocking. The distal interlocking slot makes primary or secondary axial dynamization possible.
  • The nail’s distal flexibility and optimal distance between the interlocking bolt and the tip of the nail minimize stress concentration and tension in the femoral shaft.

PFN Nail (Proximal Femoral Nail) Sizes

  • PFN Nail (Proximal Femoral Nail) Short sizes: Distal diameter 9-13 mm, Angle 130° or 135°, Length from 180 to 240 mm. Available in both stainless Steel and Titanium.
  • PFN Nail (Proximal Femoral Nail) Long sizes: Distal diameter 9-13 mm, Angle 130° or 135°, Length from 300 to 420 mm. Available in both stainless Steel and Titanium. Proximal Femoral Nail available for both Left and Right.
  • 4.9 mm Locking Bolt Sizes: Length from 22 to 100 mm in both stainless Steel and Titanium.
  • 6.4 mm Bolt Sizes: Length from 55 to 130 mm in both stainless Steel and Titanium.
  • 8 mm Bolt Sizes: Length from 70 to 120 mm in both stainless Steel and Titanium.

PFN Nail (Proximal Femoral Nail) Uses

PFN Short Indications: The short femoral nail is used for small stature.

  • Pertrochanteric fractures
  • Intertrochanteric fractures
  • High subtrochanteric fractures

PFN Short Contraindications

  • Low subtrochanteric fractures
  • Femoral shaft fractures
  • Isolated or combined medial femoral neck fractures

PFN Long Indications

  • Low and extended subtrochanteric fractures
  • Ipsilateral trochanteric fractures
  • Combination of fractures (trochanteric area / shaft)
  • Pathological fractures

PFN Long Contraindications
Isolated or combined medial femoral neck fractures

Proximal Femoral Nail Uses

PFN Nail (Proximal Femoral Nail) Instruments Set

PFN Nail Instruments Set

Our Orthopedic Instruments Set comprises many of items which are manufacture by superior grade of stainless steel, Aluminum and Carbon Fiber etc. These are the tools specifically designed to carry out different actions and to achieve various purposes during a surgery or an operation. We are giving our best efforts to keep the same quality standards of all orthopedic instruments as needed.

We are keeping wide range of instruments in PFN Nail Instruments Set to ensures that Doctors get almost all required items during surgery for this instruments set. Instruments can be modified according to the customer’s requirement. All these instruments can be used several times.

Below are list of items in PFN Nail Instruments Set.

  • Trocar for 8 mm Protection Sleeve : 1 Qty
  • Trocar for 6.4 mm Protection Sleeve : 1 Qty
  • Guide Wire Sleeve for 2 mm Guide Wire : 1 Qty
  • Guide Wire Sleeve for 2.5 mm Guide Wire : 1 Qty
  • Drill Sleeve for 4 mm Drill Bit : 1 Qty
  • Protection Sleeve for 4 mm Drill Sleeve : 1 Qty
  • Protection sleeve for 6.4 mm reamer : 1 Qty
  • Protection sleeve for 8 mm reamer : 1 Qty
  • Ram Rod : 1 Qty
  • Ram : 1 Qty
  • Spanner 17 mm : 1 Qty
  • PFN Nail Holding Bolt : 1 Qty
  • Driving Head : 1 Qty
  • PFN Target Device, 135° : 1 Qty
  • Tissue Protector : 1 Qty
  • Holding Forcep for Guide Wire : 1 Qty
  • Bone Awl : 1 Qty
  • Hexagonal Screw Driver Cannulated for 8 mm and 6.4 mm Bolts : 1 Qty
  • Hexagonal Screw Driver for 4.9 mm Bolts : 1 Qty
  • Depth Gauge 110 mm with Long Sleeve : 1 Qty
  • Medullary Tube, 450 mm Length : 5 Qty
  • Threaded Guide Wire 2.5 mm, 450 mm Long : 1 Qty
  • Reamer for 6.4 mm PFN Bolt : 1 Qty
  • Reamer for 8 mm PFN Bolt : 1 Qty
  • Proximal Cannulated Reamer 15 mm : 1 Qty
  • Drill Bit 4 mm, Plain Shank, 250 mm Long : 1 Qty
  • Drill Bit 3.5 mm, Plain Shank, 250 mm Long : 1 Qty
  • Graphics Aluminium Box with Silicone Fittings : 1 Qty

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PFN Nail (Proximal Femoral Nail) Contraindications

Contraindications may be qualified or total, and need to be taken into consideration when evaluating the prognosis in each case. 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.
  • All associated diseases which could endanger the function and success of the PFN Nail.

Warnings and Precautionary for PFN Nail (Proximal Femoral Nail)

Before using PFN Nail (Proximal Femoral 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.

PFN Nail is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Femoral Nail 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  Proximal Femoral Nail 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 Nail, 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 PFN Nail (Proximal Femoral Nail).
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for PFN Nail (Proximal Femoral 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 PFN Nail (Proximal Femoral 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.

PFN Nail (Proximal Femoral 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 Nail.
  • 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.

PFN Nail (Proximal Femoral Nail) Warnings

  • PFN Nail (Proximal Femoral 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. Nail removal should be followed by adequate post-operative management to avoid refracture.

PFN Nail (Proximal Femoral 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 PFN Nail (Proximal Femoral Nail), reoperation.

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 PFN Nail (Proximal Femoral Nail) 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.