Orthopedic Screw Implants User Manual

1. Introduction

About Jindal Medi Surge

Jindal Medi Surge is a leading manufacturer of orthopedic implants, committed to delivering high-quality medical devices that meet the needs of healthcare professionals and improve patient outcomes. Our orthopedic screw implants are designed to offer stability, durability, and precision in various orthopedic surgical procedures.

Purpose of the Manual

This manual provides comprehensive guidance on the proper use, maintenance, and handling of Jindal Medi Surge orthopedic screw implants. It is intended for use by healthcare professionals, including surgeons, nurses, and other medical staff involved in orthopedic surgery.

Overview of Orthopedic Screw Implants

Orthopedic screw implants are vital components in the fixation of bone fractures, spinal surgeries, and other reconstructive procedures. These implants help stabilize bone fragments, facilitating proper alignment and healing while ensuring mechanical integrity and long-term function.

2. Safety Information

General Safety Instructions

• Ensure all surgical staff are trained and familiar with the use of orthopedic screw implants.

• Always adhere to sterile techniques during surgery.

• Inspect all implants and instruments for damage or contamination before use.

• Verify compatibility between implants and instruments to avoid mismatches.

Indications and Contraindications

Indications:

• Bone fracture fixation

• Spinal fusion procedures

• Osteotomy and deformity correction

• Arthrodesis (joint fusion)

Contraindications:

• Active infection at the surgical site

• Severe osteoporosis or poor bone quality

• Allergies to implant materials

• Inadequate bone stock for secure screw placement

Warnings and Precautions

• Avoid reusing single-use implants to prevent infection or implant failure.

• Select the appropriate screw type and size for each procedure.

• Do not apply excessive force during screw insertion to avoid bone damage or screw stripping.

• Monitor patients postoperatively for any signs of infection, screw loosening, or implant failure.

Sterilization and Handling Guidelines

• Sterilize all implants and instruments before use according to the manufacturer's instructions.

• Handle sterile implants carefully to prevent contamination.

• Store implants in a controlled environment to maintain sterility and avoid exposure to moisture or extreme temperatures.

3. Product Descriptions

Types of Orthopedic Screw Implants

1. Cortical Screws

• Description: Screws with fine threads designed for dense cortical bone.

• Applications: Long bone fractures, diaphyseal fractures.

2. Cancellous Screws

• Description: Screws with coarse threads designed for spongy cancellous bone.

• Applications: Metaphyseal fractures, softer bone structures.

3. Locking Screws

• Description: Screws that lock into a plate to create a fixed-angle construct.

• Applications: Osteoporotic bone, complex fractures.

4. Cannulated Screws

• Description: Hollow screws designed for use over a guidewire for precise placement.

• Applications: Hip fractures, minimally invasive surgeries.

5. Headless Compression Screws

• Description: Screws with no head, used for compression in small bones.

• Applications: Scaphoid fractures, small joint fusions.

Components and Accessories

• Guide Wires: Used with cannulated screws for accurate placement.

• Screwdrivers: Compatible with various screw head designs (hex, star).

• Drill Bits: Sized to match the screw diameter for creating pilot holes.

• Countersinks: Tools for creating recesses in cortical bone for screw heads.

Materials Used

• Titanium Alloy: Lightweight, biocompatible, and corrosion-resistant.

• Stainless Steel: Durable, reliable, and commonly used in orthopedic applications.

• Bioabsorbable Polymers: Materials that gradually dissolve for temporary fixation.

Sizes and Specifications

Refer to the appendix for a detailed chart listing available screw sizes, diameters, lengths, and thread configurations.

4. Preparation and Surgical Technique

Preoperative Planning

• Conduct thorough preoperative imaging (e.g., X-rays, CT scans) to assess the fracture or surgical site.

• Select the appropriate screw type, size, and length based on the specific surgical requirements and patient anatomy.

• Ensure all necessary surgical instruments and implants are sterilized and ready for use.

Surgical Instruments Required

• Screwdrivers (hex, star, or other types as required)

• Drill bits (matched to the screw diameter)

• Taps (for threading in dense bone)

• Depth gauges (for measuring screw length)

• Countersinks (for cortical bone recesses)

Step-by-Step Surgical Procedure

General Steps for Screw Insertion:

1. Patient Positioning: Position the patient according to the surgical site (e.g., supine, prone).

2. Incision: Make an incision to access the bone or fracture site.

3. Fracture Reduction: Align the fracture fragments using clamps or reduction tools.

4. Drilling: Use the drill bit to create a pilot hole in the bone at the correct angle.

5. Tapping: (If necessary) Tap the pilot hole in dense bone to create threads.

6. Screw Insertion: Insert the screw using the appropriate screwdriver, ensuring it is fully seated without over-tightening.

7. Wound Closure: Close the incision and apply sterile dressings.

Postoperative Care

• Immobilize the surgical site as necessary based on the procedure.

• Monitor the patient for signs of infection, screw loosening, or implant failure.

• Follow the surgeon's recommendations for postoperative care, including physical therapy and rehabilitation as needed.

5. Maintenance and Handling

Cleaning and Sterilization Procedures

• Cleaning: Thoroughly clean screws and instruments immediately after use to remove biological debris.

• Inspection: Inspect implants and instruments for signs of wear, damage, or corrosion before each use.

• Sterilization: Sterilize implants and instruments using an autoclave according to the manufacturer's guidelines.

• Storage: Store sterilized implants in a dry, sterile, and temperature-controlled environment.

Storage Instructions

• Store implants in clearly labeled trays or containers, organized by type and size.

• Keep implants in sealed, sterile packaging to prevent contamination.

• Maintain inventory records to monitor stock levels and track expiration dates.

Handling of Implants and Instruments

• Handle implants and instruments with care to avoid damage or contamination.

• Use designated tools for screw insertion to ensure proper technique and avoid implant failure.

• Always follow aseptic techniques during surgery to maintain patient safety.

6. Troubleshooting

Common Issues and Solutions

• Screw Loosening:

  • Ensure the correct screw length and diameter are selected.

  • Verify secure fixation during surgery and consider using locking screws if necessary.

• Screw Breakage:

  • Select screws made from appropriate materials for the load requirements.

  • Avoid over-tightening and ensure proper screw placement.

• Difficulty in Screw Insertion:

  • Ensure the pilot hole is correctly sized and angled.

  • Consider pre-tapping the hole in dense cortical bone.

• Stripping of Screw Head:

  • Use the correct screwdriver and apply steady pressure during insertion.

  • Avoid reusing screws to prevent head deformation.

Contact Information for Technical Support

For assistance, contact Jindal Medi Surge at:

• Email: info@jmshealth.com

• Website: www.jmshealth.com

7. References

Clinical Studies and Literature

• A selection of relevant clinical studies and peer-reviewed articles supporting the use of Jindal Medi Surge orthopedic screw implants.

Regulatory and Compliance Information

• Details on regulatory approvals and compliance with international standards for medical devices.