4 mm Headless Compression Screw Specification, Uses, Sizes and Surgical Technique

4 mm Headless Compression Screw

4 mm Headless Compression Screw Specification

  • Headless design: Headless design of 4 mm Headless Compression Screw allows the screw implantation in and around articular regions with minimal soft tissue irritation or risk of interference.
  • Cannulated, for accurate insertion: Cannulated design facilitates accurate percutaneous insertion with minimal soft tissue damage.
  • Gradual compression through variable thread pitch: The wider thread pitch at the tip of the screw penetrates the bone faster than the finer trailing threads, compressing the two fragments gradually as the screw is advanced.
  • Fully threaded: Fully threaded screw provides a higher holding force resulting in increasing stability.
  • Sharp cutting flutes: Sharp cutting flutes in the screw tip facilitate screw insertion.
  • Two types of screws, Fully threaded, Partially threaded.
  • 4 mm Headless Compression Screw available in both Titanium and Stainless Steel.
  • 4 mm Headless Compression Screw available sizes are 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 32mm, 34mm, 36mm, 38mm and 40mm.
  • Any additional length of this screw will be made on demand.
  • Instruments are available for this screw such as Bone Taps, Combined Drill & Tap Sleeve, Counter Sink, Depth Gauge, Drill Bits, Drill Guide, Drill Sleeve, Hollow Mill Screw Removal, Reverse Measuring Device, Screw Drivers and Screw Holding Forceps etc.
  • This is Self Tapping Screw. Self Tapping Screws cuts its own thread while being driven into the bone. It makes a small hole while entering the bone which creates a tight friction fit between the threads. This helps fight vibration loosening and allows the parts to be taken apart if needed.
  • Sterile and non-sterile packaging options available for Headless Compression Screws

4 mm Headless Compression Screw Uses

Headless Compression Screws Uses

Headless Compression Screws Uses 2

Headless Compression Screws are designed to be used in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.

4 mm Headless Compression Screw is intended for bone fixation of the hand and foot flowing trauma or osteotomy. Self ­Tapping and reverse cutting flutes on both ends of the screw aid with insertion and removal. Tapered profile gaining compression and maximizing pull-out strength along its entire length.

4 mm Headless Compression Screw is intended for use as fixation devices for small bones, bone fragments, and osteotomies. They are not intended for interference or soft tissue fixation.

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Headless Compression Screws Surgical Techniques

Volar Scaphoid Technique for 4 mm Headless Compression Screw

1. Approach and Needle Insertion

The procedure can be carried out using the volar traction approach or using a conventional volar type approach with the arm supine on a hand table. The volar traction approach facilitates reduction of a displaced fracture and permits arthroscopy to ensure accuracy of the reduction.
Fluoroscopy is used throughout.

The entry point is then located using a 12 or 14 gauge IV needle introduced on the antero-radial aspect of the wrist just radial to and distal to the scaphoid tuberosity. This serves as a trochar for the guide wire and is a directional aid to establish a central path along the scaphoid. The needle is then insinuated into the scaphotrapezial joint, tilted into a more vertical position and the position is checked on the under image
intensifier. By gently levering on the trapezium this maneuver brings the distal pole of the scaphoid more radial and thus ultimately facilitates screw insertion. The entry point should be approximately 1/3 the way across the scaphoid from the tuberosity in the A/P plane and central in the lateral plane.

2. Guide Wire Insertion

Pass the guide wire through the needle and drill it across the fracture, continually checking the direction on the image intensifier and correcting as necessary, aiming for the radial aspect of the proximal pole. It is extremely important not to bend the guide wire and any adjustments in direction should be made using the needle as a guide rather than attempting to alter the line of the guide wire alone.

3. Determine Screw Length

Advance the guide wire to stop just short of the articular surface as the wire should not breach it at this stage. The position, alignment and length are checked once more. Make a simple stab incision at the entry point of the wire, and deepen this down to the distal pole of the
scaphoid using a small hemostat and blunt dissection.

Determine the length of the screw either with the appropriate depth gauge or by advancing a second guide wire of the same length up the distal cortex of the scaphoid and subtracting the difference between the two. When using the volar approach, the correct screw size is 2–4 mm shorter than the measured length so as to ensure that the proximal tip of the screw is fully buried below the cartilage and the cortical surface.

4. Advance Guide Wire

Advance the guide wire through the proximal pole of the scaphoid so as to exit on the dorsal aspect of the wrist. This is a precautionary measure to minimize the risk of inadvertent withdrawal of the wire during the reaming process and screw insertion and to facilitate removal of the
proximal portion if the wire were to break. A second de-rotation wire can then be inserted in those cases where it is felt that there is a possibility of rotational instability of the fracture.

5. Drill

Remove the 12 gauge needle and pass the Cannulated Profile Drill over the wire using either a power drill or by hand stopping 1–2 mm short of the articular surface. The long drill is recommended to mitigate the effects of varying bone density and distraction upon screw insertion.

6. Advance Self-Tapping Screw

The self-tapping screw is then advanced over the guide wire and the wire removed. Compression can then be confirmed radiographically on the image intensifier.

1. Approach and Needle Insertion

Headless Compression Screws Surgical Techniques 1

2. Guide Wire Insertion

Headless Compression Screws Surgical Techniques 2

3. Determine Screw Length

Headless Compression Screws Surgical Techniques 3

4. Advance Guide Wire

Headless Compression Screws Surgical Techniques 4

5. Drill

Headless Compression Screws Surgical Techniques 5

6. Advance Self-Tapping Screw

Headless Compression Screws Surgical Techniques 6

Dorsal Scaphoid Technique for 4 mm Headless Compression Screw

1.   APPROACH AND NEEDLE INSERTION
The entry point in the proximal pole is at the tip of the scaphoid immediately adjacent to the scapholunate ligament. This can be located either using an arthroscopy or mini open dorsal approach between the third and fourth extensor compartments. Whichever approach is employed, it is essential to ensure that the guide wire does not transfix an extensor tendon.

Having established the entry point, introduce the appropriate guide wire aiming for the base of the thumb and check the position on the fluoroscope. Aim to place the leading edge of the guide wire in the subchondral surface of the distal pole of the scaphoid. Confirm the wire placement and depth under imaging.

2.  FRACTURE STABILIZATION
If the fracture is unstable it may be helpful to place a second parallel guide wire using the parallel wire guides.

3.  DETERMINE SCREW LENGTH
Measure guide wire length using either the percutaneous screw sizer, or by placing a second wire at the entry point and subtracting the difference. The screw sizer cannot be used with the arthroscopic technique due to the limited access. Subtract 4 mm from the measured length to ensure that both ends of the screw are buried within the bone.

4.  ADVANCE GUIDE WIRE
Advance the guide wire through the far cortex so that it lies in the subcutaneous tissues. This minimizes the risk of accidental withdrawal of the guide wire while drilling and facilitates wire removal if it should break.
Tip: For most adult males the screw should not be longer than 26 mm, and in females 22 mm.

5.  DRILL NEAR CORTEX
Open the near cortex with the appropriate profile drill.

6.  DRILL FAR FRAGMENT
Next, drill into the far fragment with the long drill. To be effective the drill only has to advance 4–5 mm past the fracture site.
Tip: The long drill is recommended to mitigate the effects of varying bone density and distraction upon screw insertion.

7.  SCREW INSERTION
Insert the correctly sized screw with the appropriate hex driver. If resistance is met upon insertion or if distraction occurs, stop, remove the screw, redrill with the long drill, and re-insert the screw. Confirm placement and length of the screw on imaging, ensuring that both leading and trailing edges of the screw are beneath the articular surfaces. Finally remove the guide wires.

1. Approach and Needle Insertion

Headless Compression Screws Surgical Techniques 7

2. Fracture Stabilization

Headless Compression Screws Surgical Techniques 8

3. Determine Screw Length

Headless Compression Screws Surgical Techniques 9

4. Advance Guide Wire

Headless Compression Screws Surgical Techniques 10

5. Drill Near Cortex

Headless Compression Screws Surgical Techniques 11

6. Drill Far Fragment

Headless Compression Screws Surgical Techniques 12

7. Screw Insertion

Headless Compression Screws Surgical Techniques 13

Different Types of Screws including 4 mm Headless Compression Screw

Cancellous Screws

Cannulated Screws

  • 2.5 mm Headless Compression Screws Partially Thread
  • 3 mm Headless Compression Screws Partially Thread
  • 3.5 mm Headless Compression Screws Partially Thread
  • 4 mm Headless Compression Screws Partially Thread
  • 4.5 mm Headless Compression Screws Partially Thread
  • 5.5 mm Headless Compression Screws Partially Thread
  • 6.5 mm Headless Compression Screws Partially Thread
  • 7.5 mm Headless Compression Screw Partially Thread
  • 5 mm Interference Screw
  • 6 mm Interference Screw
  • 7 mm Interference Screw
  • 8 mm Interference Screw
  • 9 mm Interference Screw
  • 10 mm Interference Screw

Bone screws are the most commonly used orthopedic implants. There are many different types and sizes of screws for different types of bones. Most bone screws are made out of stainless steel or titanium alloys. The outer diameter, root diameter, and thread pitch and angle are important in determining screw mechanics.

In orthopedics, screws are typically described by their outer diameter, for example, a “4 mm Headless Compression Screw” has an outside diameter of 4 mm. The pitch of a screw is the linear distance travelled by a screw for one full turn of the screw. The screw advances by a distance equal to the distance between the threads with each full turn. Cortical screws have a lower pitch and therefore more number of threads. Cancellous bone screws have a greater depth of the screw to increase the surface area and therefore improve the purchase, as the bone is weaker.

Screws function by converting the tightening torque into internal tension in the screw and elastic reactions in the surrounding bone. This creates compression between the fracture fragments that the screw is holding together. Screw is typically inserted into holes drilled equal to the root diameter and are either self-tapping or are inserted tapped (threaded) holes. The torque to insert cortical bone screws can be high, so the screws must be properly inserted into the correct size drilled hole and designed to withstand insertion torque levels expected in cortical bone. Cancellous bone screws have large, deep threads that grip the spongy bone well. Because of the relatively low strength of the cancellous bone, failure of the screw itself during insertion is rare, but pull out can be an issue.

4 mm Headless Compression Screw 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 4 mm Headless Compression Screw.

Warnings and Precautionary for 4 mm Headless Compression Screw

Before using 4 mm Headless Compression Screw, 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.

Screws are made from medical grade materials and are designed, constructed and produced with utmost care. These quality screw 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  screw 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 screw, 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 4 mm Headless Compression Screw.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for 4 mm Headless Compression Screw

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 4 mm Headless Compression Screw 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.

4 mm Headless Compression Screw 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.

4 mm Headless Compression Screw Warnings

  • 4 mm Headless Compression Screw 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.

4 mm Headless Compression Screw 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.