Expert Tibia Nail Specification, uses, Sizes and Surgical Techniques

Expert Tibia Nail

Expert Tibia Nail Specification

Versatile proximal locking options in Expert Tibia Nail

  • Versatile proximal locking options. Three unique and innovative locking options, in combination with cancellous bone locking screws, increase the stability of the proximal fragment for proximal third fractures.
  • Two state of the art medio-lateral (ML) locking options enable primary compression or secondary controlled dynamization.

End caps

  • Securely lock the most proximal oblique locking screw to create a fixed-angle construct
  • End cap prevents ingrowth of tissue and facilitates nail extraction
  • Self-retaining Screw Driver recess for effortless end cap pick-up and ease of insertion
  • 0mm end cap sits flush with nail
  • 5mm, 10mm and 15mm end caps extend nail height if nail is over inserted Cannulated

Advanced nail design

  • New anatomic bend for ease of insertion
  • Titanium alloy for improved mechanical and fatigue properties
  • Cannulated nails (from Ø 8mm to Ø 13mm) for reamed or unreamed techniques, enabling nail insertion over guide wire
  • 2.5mm or 3mm ball tipped guide wires may be removed through the nail and insertion handle assembly (no exchange tube required).
  • Solid nails (from Ø 8mm to Ø10 mm) for unreamed technique

Advanced distal locking options in Expert Tibia Nail

  • Distal oblique locking option to prevent soft tissue damage and increase stability of the distal fragment
  • Two ML and one antero-posterior (AP) locking options for stability of the distal fragment

All locking screws

  • Double lead thread for more contact points for enhanced stability and ease of insertion
  • Thread closer to screw head providing better bone purchase in the near cortex and improved stability
  • Titanium alloy for improved mechanical and fatigue properties
  • Self-tapping blunt tip
  • Self-retaining Screw Driver recess allows improved torque transmission and increased resistance to stripping relative to a hex recess and secure locking screw pick-up.

Cancellous bone locking screws

  • Indicated for the three unique proximal locking options of all tibia nails diameters
  • Dual core design for optimized purchase in cancellous bone
  • Unicortical

Expert Tibia Nail Uses

Expert Tibia Nail Uses

Expert Tibia Nail is indicated for fractures in the tibial shaft as well as for metaphyseal and certain intraarticular fractures of the tibial head and the pilon tibiale.

Case 1: Fracture involving the proximal component
The use of the three locking screws in the proximal oblique locking options ensures optimal stabilization of the proximal fragment. The distal segment can be stabilized by using two ML locking options. Stability of the distal fragment can be enhanced by the use of a third locking screw in the AP hole.

Case 2: Shaft fracture
For simple shaft fractures, two proximal ML and two distal ML locking screws are normally sufficient to stabilize the fracture. Secondary dynaminization is achieved by removing the proximal static locking screw.

Case 3: Fracture involving the distal component
The use of four distal locking screws in Expert Tibia Nail is sometimes necessary to achieve stabilization of the distal fragment. In many cases though, three locking screws placed in the most distal locking options are sufficient to stabilize the distal fragment.

Expert Tibia Nail Instruments Set

Expert Tibia Nail Instruments Set

Expert Tibia Nail Instruments Set contains instruments required for Expert Tibia Nail with two Jig : Distal Jig and Proximal Jig.

Expert Tibia Nail Instruments Set Features:

  1. Instruments for Expert Tibia Nails.
  2. Instruments are organised in general order of use.
  3. Expert Tibia Nail Instruments Set can be modified according to customer requirements and preference also, in this case minimum quantities are required.
  4. Instruments are fitted in Silicon Foam.
  5. Graphics of instruments are made in instruments Box to keep Instruments at their define places.

Below are list of items in Expert Tibia Nail Instruments Set.

  • Depth Gauge for Locking Screws, measuring range up to 110 mm : 1 Qty
  • Drill Bit 3.2 x 250 mm : 1 Qty
  • Drill Bit 4 x 250 mm : 1 Qty
  • Reamer Cannulated, T Handle : 1 Qty
  • Drill Sleeve 3.2 mm : 1 Qty
  • Protection sleeve for drill Sleeve 3.2 mm : 1 Qty
  • Trocar : 1 Qty
  • Drill Sleeve 4 mm : 1 Qty
  • Protection Sleeve for Drill Sleeve 4 mm : 1 Qty
  • Screw Driver for 3.9 mm and 4.9 mm Locking Bolt : 1 Qty
  • Bone Awl : 1 Qty
  • Tissue Protector : 1 Qty
  • Teflon Tube : 1 Qty
  • Arm for Distal Jig : 1 Qty
  • Arm for Distal Jig : 1 Qty
  • Insertion Driving Head : 1 Qty
  • Pin Wrench : 1 Qty
  • Ram and Ram Rod : 1 Qty
  • Ram Rod Handle : 1 Qty
  • Nail Holding Bolt for Expert Tibia Nail : 1 Qty
  • Nail Holding Bolt for Expert Tibia Nail : 1 Qty
  • Spanner : 1 Qty
  • Distal Jig : 1 Qty
  • Proximal Jig : 1 Qty
  • Graphics Aluminium Box with Silicone Fittings : 1 Qty

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Expert Tibia 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 Expert Tibia Nail.

Warnings and Precautionary for Expert Tibia Nail

Before using Expert Tibia 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.

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  Expert Tibia 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 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 Expert Tibia Nail.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for Expert Tibia 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 Expert Tibia 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.

Expert Tibia 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.

Expert Tibia Nail Warnings

  • Expert Tibia 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.

Expert Tibia 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 Expert Tibia Nail, reoperation.