Humeral (Humerus) Nail Specification, Uses, Sizes and Surgical Techniques.

Humeral (Humerus) Nail

Humeral (Humerus) Nail System offers the competitive advantages of:

Brief operative time
Minimal morbidity
Early return to function of the extremity
In 90% of the cases, no external support is needed
Closed technique
Low infection rate
Very good pain relief in stabilization of pathological fractures

Compared to Plate and Screw Osteosynthesis :

Minimal damage to muscle, connective tissue and vasculature
Reduced periosteal stripping and concomitant soft tissue damage
Fewer radial nerve palsies
Designed for load sharing instead of load bearing
Cosmetically smaller incision

Humeral (Humerus) Nail System is the realization of superior biomechanical intramedullary stabilization.

The system offers the option of different locking modes :
• Static, transverse/oblique
• Dynamic
• Apposition/compression
• Advanced locking

In some indications, a controlled apposition/compression of bone fragments can be applied by introducing a compression screw from the top of nail. To further increase rotational stability, the nail can be locked after utilizing the apposition/compression feature.

The compression screw is pushed against the proximal Partially Threaded Locking Screw (Shaft Screw) that has been placed in the oblong hole, drawing either the distal or the proximal segment towards the fracture site. In stable fractures, this has the biomechanical advantage of
creating active circumferential compression to the fracture site, transferring axial load to the bone, and reducing the function of the nail as a
load bearing device.

This ability to transfer load back to the bone can reduce the incidence of implant failure secondary to fatigue. Typical statically locked nails functioning as load bearing devices have reported failure rates in excess of 20%.

Common 4mm cortical screws simplify the surgical procedure. Fully Threaded Locking Screws are available for regular locking procedures.
Partially Threaded Locking Screws (Shaft Screws) are designed for application of apposition/compression.

One common Humeral Compression Screw to close the fracture site, and End Caps in six sizes are available to provide an improved fit for every indication to allow nail length adaptation after insertion and to prevent bone ingrowth.

Humeral (Humerus) Nail Uses

Humeral (Humerus) Nail is indicated for:

Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus.
The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked.
The subject and predicate devices are indicated for use in the humerus.
Types of fractures include, but not limited to fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

Humeral (Humerus) 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 Humeral (Humerus) Nail.

Humeral (Humerus) Nail Instruments Set

Humerus Nail Instruments Set

Humeral (Humerus) Nail Instruments Set contains instruments required for Humeral (Humerus) Nail.

Features:

Instruments for Humeral (Humerus) Nail.
Instruments are organised in general order of use.
Instruments are fitted in Silicon Foam.
Graphics of instruments are made in instruments Box to keep Instruments at their define places.

Below are list of items in Humeral (Humerus) Nail Instruments Set:

Jig for Humerus Nail: 1 qty
Conical Bolt for Jig: 1 qty
Protection Sleeve: 1 qty
Trocar: 1 qty
Drill Sleeve: 1 qty
Depth Gauge measuring upto 110 mm: 1 qty
Screw Driver: 1 qty
Bone Awl Cannulated: 1 qty
Spanner: 1 qty
Rod Handle: 1 qty
Rod: 1 qty
Ram: 1 qty
2 mm Guide Wire: 2 qty
Drill Bit, 2.7 mm x 225 mm: 2 qty
Reamer T handle Cannulated 6 mm: 1 qty
Reamer T handle Cannulated 7 mm: 1 qty
Reamer T handle Cannulated 8 mm: 1 qty
Graphics Aluminium Box with Silicone Fittings: 1 qty

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Warnings and Precautionary for Humeral (Humerus) Nail

Before using Humeral (Humerus) 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.

Humeral (Humerus) 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 nails, 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 Humeral (Humerus) Nail.
Mechanical failure of the implant, including bending, loosening or breakage.
Migration of implant resulting in injury.

Preoperative Planning for Humeral (Humerus) 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 Humeral (Humerus) 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.

Humeral (Humerus) 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.

Humeral (Humerus) Nail Warnings

Humeral (Humerus) 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.

Humeral (Humerus) 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 Humeral (Humerus) Nail, reoperation.

Instruments

Bone Plates

Other Implants

Bone Screws

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Humeral (Humerus) Nail Specification, Uses, Sizes and Surgical Techniques.

Humeral (Humerus) Nail Uses

Humeral (Humerus) Nail is indicated for:

Humeral (Humerus) Nail Contraindications:

Humeral (Humerus) Nail Instruments Set

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