3.5 mm Locking Extra Articular Distal Humerus Plates Specification, Uses, Sizes & Surgical Instruments.

3.5 mm Locking Extra Articular Distal Humerus Plates

3.5 mm Locking Extra Articular Distal Humerus Plates Specification

  • Plates available holes are 4, 6, 6, 8, 10, 12, 14 and 16.
  • Plates available for Left and Right both direction
  • Plate has combi holes and round holes. Combi holes allow fixation with locking screws in the threaded section and cortex screws in the dynamic compression unit section for compression.
  • The shaft holes accept 3.5 mm locking screws in the threaded portion or 3.5 mm cortical screws or 4 mm cancellous screws in the compression portion. Distal locking holes in plate head accept 3.5 mm locking screws.
  • 3.5 mm Locking Extra Articular Distal Humerus Plates allow implant placement to address the individual fracture pattern.
  • Limited-contact surface reduces bone-to-plate contact and helps to preserve the periosteal blood supply.
  • Choice of different lengths of plate eliminates the need to cut plates.
  • Pre-contoured plate to match anatomical shape.
  • Available in both Titanium and Stainless steel.
  • locking plate increases construct stability, decreases risk of screw back-out and subsequent loss of reduction. It also reduces the need for precise anatomic plate contouring and minimizes the risk of stripped screw holes.
  • A complete Instruments Set is available for 3.5 mm Locking Extra Articular Distal Humerus Plates. General Instruments are available for this plate such as Plate Bending Press, Plate Holding Forceps, Plate Bending Pliers, Bone Holding Forceps, Bone Elevators, Bone Cutter, Bone Nibbler, Depth Gauge, Sleeve, Screw Driver, Trocar Sleeve etc.

3.5 mm Locking Extra Articular Distal Humerus Plates Uses

3.5 mm Locking Extra Articular Distal Humerus Plates are indicated for fractures of the distal humerus.

Instruments for 3.5 mm Locking Extra Articular Distal Humerus Plates.

3.5 mm Locking Instruments Set

A complete instruments set are also available for 3.5 mm Locking Extra Articular Distal Humerus Plates. Instruments can be modified according to the customer’s requirement with minimum quantity required. All these instruments can be used several times.

We are keeping wide range of  instruments items in this set to ensures that Doctors get almost all required items during. Below is list of items of this set.

  • Allen Key for Dill Bit Stopper
  • Countersink for 3.5/4 mm Screws
  • Depth Gauge Measuring range upto 60 mm
  • Double Drill Guide 3.5/2.5 mm
  • Double Drill Guide 4.0/2.5 mm
  • Drill Bit 2.5 mm x 125 mm, Quick Coupling
  • Drill Bit 2.8 mm x 165 mm with Stopper, Quick Coupling
  • Drill Bit 3.5 mm x 130 mm, Quick Coupling
  • Drill Guide 3.5 mm for Neutral and Load Position
  • Extraction Screw 3.5 mm
  • Guide Sleeve for 1.2 mm K Wires
  • Guide Wire Threaded Trocar 1.2 mm x 280 mm
  • Hohmann Retractor 12 mm
  • Insert Drill Sleeve 3.5/2.5 mm
  • Periosteal Elevator Fiber Handle 6 mm
  • Plate Bender
  • Plate Bending Template
  • Reduction Forcep Pointed Speed Lock 150 mm
  • Reduction Forcep Serrated Speed Lock 150 mm
  • Self Centering Bone Holding Forcep Speed Lock 190 mm
  • Screw Holding Forceps
  • Screw Driver Hexagonal, Holding Sleeve, 2.5 mm Tip
  • Screw Driver Torque for 3.5 mm Locking Screws
  • Screw Driver Quick Coupling for 3.5 mm Locking & 3.5 mm Cortical
  • Sharp Hook
  • T Handle Quick Coupling
  • Tap T Handle for 3.5 mm Cortical Screws
  • Tap T Handle for 4 mm Cancellous Screws
  • Threaded Drill Guide 3.5 for Drill Bit 2.8 mm
  • Trephine
  • Graphics Aluminum Box with Silicone Fittings

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Advantages of using locking plate for 3.5 mm Locking Extra Articular Distal Humerus Plates

  • 3.5 mm Locking Extra Articular Distal Humerus Plates is a locking plate so it does not have to precisely contact the underlying bone in all areas. When screws are tightened, they “lock” to the threaded screw holes of the plate, stabilizing the segments without pulling the bone to the plate. Locking screws make it impossible for screw insertion to alter the reduction. Nonlocking plate/screw systems require a precise adaptation of the plate to the underlying bone. Without this close contact, tightening of the screws will pull the bone segments toward the plate, resulting in loss of reduction and possibly the occlusal relationship
  • Locking plate/screw systems do not disrupt the underlying cortical bone perfusion as much as conventional plates, which compress the plate to the cortical bone.
  • Screws are unlikely to loosen from the plate. Similarly, if a bone graft is screwed to the plate, a locking head screw will not loosen during the phase of graft incorporation and healing. The possible advantage to this property of a locking plate/screw system is decreased risk of inflammatory complications due to hardware loosening.
  • Locking plate/screw systems have been shown to provide more stable fixation than conventional nonlocking plate/screw systems.

Locking Screw Technology

The heads of the locking screws contain male threads while the holes in the plates contain female threads. This allows the screw head to be threaded into the 3.5 mm Locking Extra Articular Distal Humerus Plates hole, locking the screw into the plate. This technical innovation provides the ability to create a fixedangle construct while using familiar plating techniques.

Locking Plate Technology

By using locking screws in a bone plate, a fixed-angle construct is created. In osteopenic bone or fractures with multiple fragments, secure bone purchase with conventional screws may be compromised. Locking screws do not rely on bone/plate compression to resist patient load, but function similarly to multiple small angled blade plates. In osteopenic bone or comminuted fractures, the ability to lock screws into a fixed-angle construct is imperative.

By combining locking screw holes with compression screw slots in the shaft, the plate can be used as both a locking device and a fracture compression device. If compression is desired, it must be achieved first by inserting the standard screws in the compression screw slots before inserting any locking screws.

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Screws available for 3.5 mm Locking Extra Articular Distal Humerus Plates

3.5 mm Locking Cortical Screws

3.5 mm Locking Cortical Screws available lengths are 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 32mm, 34mm, 36mm, 38mm, 40mm, 42mm, 44mm, 46mm, 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 60mm, 65mm, 70mm, 75mm, and 80mm.

3.5 mm Cortical Screws

3.5 mm Cortical Screws available lengths are 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 32mm, 34mm, 36mm, 38mm, 40mm, 42mm, 44mm, 46mm, 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 60mm, 65mm, 70mm, 75mm, and 80mm.

4 mm Cancellous Screws

4 mm Cancellous Screws available lengths are 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 32mm, 34mm, 36mm, 38mm, 40mm, 42mm, 44mm, 46mm, 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 60mm, 65mm, 70mm, 75mm, and 80mm.

These Screws are made from pure Titanium and SS 316L. Any additional length sizes of these screws will be made on demand.

3.5 mm Locking Extra Articular Distal Humerus Plates 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 3.5 mm Locking Extra Articular Distal Humerus Plates.

Warnings and Precautionary for 3.5 mm Locking Extra Articular Distal Humerus Plates

Before using 3.5 mm Locking Extra Articular Distal Humerus Plates, 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.

Plates are made from medical grade materials and are designed, constructed and produced with utmost care. These quality 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 Plates 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 3.5 mm Locking Extra Articular Distal Humerus Plates.

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 3.5 mm Locking Extra Articular Distal Humerus Plates, 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 Implants.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for 3.5 mm Locking Extra Articular Distal Humerus Plates

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 set of 3.5 mm Locking Extra Articular Distal Humerus Plates 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.

3.5 mm Locking Extra Articular Distal Humerus Plates 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 screw.
  • 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.

3.5 mm Locking Extra Articular Distal Humerus Plates Warnings

  • 3.5 mm Locking Extra Articular Distal Humerus Plates 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. Implant removal should be followed by adequate post-operative management to avoid refracture.

3.5 mm Locking Extra Articular Distal Humerus Plates 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 implant, reoperation.