1. Definition

What is a Gigli Saw?

A Gigli saw is a flexible, hand-operated wire saw used primarily in surgical procedures for cutting bone. It is a legacy instrument that remains indispensable in specific surgical scenarios, particularly where access is limited or where powered equipment is unsuitable or unavailable. Named after its Italian inventor, Leonardo Gigli, who introduced it in 1894 for performing pubiotomies during childbirth, its fundamental design has changed little over a century, a testament to its effectiveness. Its primary function is to perform precise, controlled osteotomies (bone cuts) through a small operative field.

How it Works

The Gigli saw operates on a simple mechanical principle. It consists of a braided wire with cutting teeth. The wire is threaded around or behind the target bone. A handle (often a simple ring or T-bar) is attached to each end of the wire. The surgeon then uses a reciprocating “pull-saw” motion, pulling alternately on each handle. This back-and-forth action engages the teeth of the wire with the bone, creating a cutting action. The flexibility of the wire allows it to be guided around anatomical structures, enabling cuts in confined spaces that a rigid saw could not reach.

Key Components

1. Cutting Wire: The core component. It is a flexible, braided stainless steel cable with fine, sharp teeth machined or etched along its length. The braiding provides strength and flexibility, preventing kinking and breakage.
2. Handles/Passers: Typically, two detachable handles (often made of stainless steel or plastic) are used to pull the saw. Some systems include a specialized “Gigli saw passer,” a blunt, curved or angled instrument used to guide the wire around the bone without damaging surrounding soft tissues (e.g., nerves, blood vessels).
3. Packaging: Often supplied sterile in a coil or packet, sometimes with the wire pre-threaded through handles or passers.

2. Uses

Clinical Applications

• Neurosurgery: Historically and still occasionally for craniotomies (skull flaps), especially in trauma or where a craniotome (powered saw) is not used. Its use here has declined but it remains a vital backup.
• Orthopedic Surgery: Its most common modern application.
  • Amputations: For cutting through long bones (e.g., femur, tibia) during above-knee or below-knee amputations.
  • Pelvic Surgery: For osteotomies of the pubic rami or other parts of the pelvis in trauma or reconstructive surgery.
  • Sternotomy Re-entry: In cardiac surgery, a Gigli saw is sometimes the safest instrument to divide the sternum during a re-operation when the heart may be adherent to the back of the breastbone, minimizing risk of injury.
• Maxillofacial Surgery: For precise cuts in the facial bones.
• Forensic Pathology: Used in autopsies to open the skull cap neatly without damaging the brain.

Who Uses It

• Surgeons: Primarily neurosurgeons, orthopedic surgeons, trauma surgeons, cardiothoracic surgeons, and maxillofacial surgeons.
• Surgical Assistants/Scrub Nurses: They may assist in threading the saw and providing tension.
• Forensic Pathologists.

Departments/Settings

• Operating Rooms (ORs) in hospitals, especially in Trauma, Orthopedics, Neurosurgery, and Cardiothoracic departments.
• Emergency Operating Theatres in field hospitals or military medicine settings due to its simplicity and reliability.
• Mortuaries and forensic labs.

3. Technical Specs

Typical Specifications

• Length: Commonly 40 cm to 60 cm.
• Wire Diameter: Typically ranges from 0.41 mm to 0.56 mm.
• Teeth Configuration: Fine, closely spaced teeth designed for a smooth cutting action on bone.
• Material: Surgical-grade stainless steel (AISI 316L or similar) for corrosion resistance and strength.

Variants & Sizes

• Length Variants: Shorter saws for pediatric use or small bones; standard lengths for adult limbs and pelvis.
• Tooth Coarseness: Some manufacturers offer variations in tooth size for different bone densities.
• Pre-Threaded Kits: Single-use, sterile kits where the wire is pre-threaded through plastic handles or specialized passers for convenience and safety.

Materials & Features

• Materials: The wire is high-tensile, flexible stainless steel. Handles can be reusable (autoclavable metal) or disposable (plastic).
• Features: Modern versions may have laser-etched teeth for enhanced sharpness and consistency. Some systems integrate with a guide or protector to shield soft tissues during the pass.

Models

While not “models” in the high-tech sense, notable product lines come from leading manufacturers like:

• Ruggles Gigli Saw: A classic, reusable design.
• Single-Use/Disposable Gigli Saw Systems: Offered by companies like Medline, Cardinal Health, and others, promoting sterility and eliminating reprocessing costs.
• Specialized Systems: Such as the Hall Surgairtome® system, which can use a Gigli saw attachment for sternotomy.

4. Benefits & Risks

Advantages

• Simplicity & Reliability: No power source required, minimal risk of mechanical failure.
• Flexibility & Access: Can cut bone in deeply situated or confined anatomical areas where rigid saws cannot fit.
• Precision & Control: Offers tactile feedback, allowing the surgeon to feel the cut and adjust force accordingly.
• Safety in Re-operations: Gold standard for safe sternal re-entry in cardiac surgery to avoid catastrophic bleeding.
• Cost-Effective: The instrument itself is inexpensive, especially reusable versions.

Limitations

• Physical Effort: Requires significant manual effort and can be tiring, especially on dense cortical bone.
• Speed: Slower than oscillating or reciprocating power saws.
• Technique-Sensitive: Requires skill to pass the wire correctly and maintain a straight cut.
• Risk of Wire Breakage: If kinked or overly stressed, the wire can snap.

Safety Concerns & Warnings

• Soft Tissue Injury: The greatest risk is injury to nerves, vessels, or viscera during the blind passing of the wire or if it slips. Use of a passer or guide is critical.
• Wire Breakage: Can cause injury from the sharp ends and delay the procedure.
• Thermal Injury: The sawing action can generate heat; intermittent irrigation with saline is recommended to cool the bone.
• Surgical Site Infection: As with any instrument, strict aseptic technique is mandatory.

Contraindications

There are no absolute patient-related contraindications. Its use is contraindicated by surgical approach or surgeon skill level—if the surgeon is not trained in its safe passage and use, or if the anatomy does not allow for safe wire placement, an alternative method must be chosen.

5. Regulation

The Gigli saw is regulated as a surgical instrument.

• FDA Class: Typically Class I (low to moderate risk). Exempt from premarket notification [510(k)] but subject to general controls (registration, labeling, GMP).
• EU MDR Class: Under EU MDR 2017/745, it is generally Class I (non-sterile, reusable) or Class Is (if supplied sterile). Rules are more stringent if it has a measuring function or is connected to an active device.
• CDSCO Category: In India, it falls under Category A (low risk) as a non-powered surgical instrument.
• PMDA Notes: In Japan, it is regulated as a Class II medical device under the Pharmaceutical and Medical Device Act (PMD Act), requiring certification from a Registered Certification Body.
• ISO/IEC Standards:
  • ISO 13485: Quality Management Systems for medical device manufacturers.
  • ISO 7153-1: Materials for surgical instruments – specifically covers stainless steel.
  • IEC 62366-1: Application of usability engineering to medical devices.

6. Maintenance

Cleaning & Sterilization (for Reusable Saws)

1. Point-of-Use Pre-cleaning: Wipe wire and handles immediately after use to remove biological debris.
2. Decontamination: Ultrasonic cleaning is ideal for the braided wire to remove particles from its interstices. Manual cleaning must be meticulous.
3. Inspection: Check wire for kinks, fraying, or weak spots. Check handles for integrity.
4. Sterilization: Autoclaving (steam sterilization) is the standard method. Follow manufacturer’s instructions for time, temperature, and pressure (e.g., 134°C for 3-5 minutes). Ensure the wire is coiled loosely to allow steam penetration.

Reprocessing

For reusable models, the entire cycle (cleaning, inspection, lubrication if specified, packaging, sterilization) must be performed by a certified sterile processing department (SPD).

Calibration

Not applicable in the electronic sense. “Calibration” refers to the functional inspection for sharpness and integrity. A blunt or damaged saw must be replaced.

Storage

Store sterile packs in a clean, dry, temperature-controlled environment. Avoid crushing or placing heavy objects on the packs. Single-use saws should be stored per manufacturer guidelines.

7. Procurement Guide

How to Select the Device

• Intended Use: Determine primary applications (orthopedic, cardiac, neuro) to select appropriate length and any specialized passers.
• Reusable vs. Single-Use: Weigh the lower per-unit cost of reusable saws against the guaranteed sterility, convenience, and eliminated reprocessing costs of disposables.
• Ergonomics: Consider handle design for user comfort during prolonged use.

Quality Factors

• Wire Integrity: Should be uniformly braided, flexible without kinking, with sharp, consistent teeth.
• Material Certification: Should be made of certified medical-grade stainless steel.
• Finish: Smooth, burr-free finish to prevent tissue drag.

Certifications

Look for CE Marking (for EU), FDA Establishment Registration, and possibly ISO 13485 certification of the manufacturer.

Compatibility

It is a standalone manual device with no electronic or power compatibility issues. Ensure any specialized passers or guides are compatible with the wire diameter.

Typical Pricing Range

• Reusable Gigli Saw (wire & handles): $50 – $150.
• Single-Use Sterile Gigli Saw System: $20 – $80 per unit.
  Bulk purchasing and contracts significantly affect price.

8. Top 10 Manufacturers (Worldwide)

1. Integra LifeSciences (USA): A global leader in neurosurgery and extremity reconstruction; offers specialized surgical instruments.
2. B. Braun Melsungen AG (Germany): Major supplier of surgical instruments and single-use surgical products globally.
3. Medtronic (Ireland/USA): Through its surgical divisions, provides instruments for neurosurgery, spine, and orthopedics.
4. Johnson & Johnson (DePuy Synthes) (USA): A powerhouse in orthopedics and neurosurgery, offering comprehensive instrument sets.
5. Stryker Corporation (USA): Strong in orthopedics and neurosurgery, providing a range of surgical tools.
6. Cardinal Health (USA): A major distributor and manufacturer of single-use surgical products and kits.
7. Medline Industries (USA): Leading manufacturer and distributor of medical supplies, including single-use Gigli saws.
8. Teleflex Incorporated (USA): Provides a wide array of surgical instruments, including specialty saws.
9. Sklar Surgical Instruments (USA): Renowned, long-standing manufacturer of high-quality reusable surgical instruments.
10. BOWA-electronic GmbH & Co. KG (Germany): Specializes in electrosurgery and surgical instruments for various disciplines.

9. Top 10 Exporting Countries (Latest Year)

(Based on HS Code 901890 for other instruments and appliances used in medical/surgical sciences)

1. United States: Dominant exporter of high-end medical devices and surgical instruments.
2. Germany: Renowned for precision-engineered surgical tools and high export value.
3. China: Major global supplier of medical instruments, offering a wide range from basic to advanced.
4. Japan: Exports high-quality, precision surgical instruments.
5. Mexico: A significant manufacturing and export hub for the North American market.
6. Ireland: Hosts many multinational med-tech companies, leading to high-value exports.
7. Switzerland: Known for premium-precision surgical instruments.
8. United Kingdom: Exports specialized surgical instruments and devices.
9. France: Significant European manufacturer and exporter.
10. Netherlands: A key European logistics and distribution hub for medical devices.

10. Market Trends

Current Global Trends

• Shift to Single-Use: Driven by infection control concerns, avoidance of reprocessing errors, and supply chain simplicity, disposable Gigli saw kits are gaining market share over reusable ones.
• Value-Based Procurement: Hospitals are bundling purchases, favoring vendors who supply entire procedural kits that include the saw.

New Technologies

• Material Science: Improvements in wire alloy composition for increased tensile strength and fatigue resistance.
• Surface Treatments: Coatings to reduce friction and potentially enhance cutting efficiency.

Demand Drivers

1. Global Surgical Volume Growth: Especially in orthopedics and trauma in aging populations.
2. Safety Protocols: Mandates for safest techniques in high-risk procedures (e.g., cardiac re-operations).
3. Military & Disaster Medicine: Reliance on simple, reliable tools in resource-limited settings.

Future Insights

The Gigli saw will not become obsolete. Its future lies in integration into specialized, safety-focused single-use kits (e.g., “sternal re-entry kits,” “limb amputation kits”). While powered tools dominate routine cases, the Gigli saw will remain the critical, fail-safe option in complex and revision surgery.

11. Training

Required Competency

Surgeons and surgical trainees must achieve competency in:

• Safe passage of the wire using a passer or finger guidance.
• Proper handle attachment and tensioning.
• Executing a controlled, reciprocal sawing motion.
• Recognizing and managing a wire breakage.

Common User Errors

• Insufficient Soft Tissue Protection: Not using a passer, leading to neurovascular injury.
• Kinking the Wire: During passage, which weakens it and leads to breakage.
• Uneven Pulling: Creating an oblique or uneven bone cut.
• Excessive Speed: Generates heat and increases breakage risk.

Best-Practice Tips

1. Always Use a Passer: Never pass the wire blindly.
2. Irrigate: Use saline irrigation frequently to cool the bone and clear debris.
3. Maintain Parallel Planes: Ensure the handles are pulled in parallel planes to keep the cut straight.
4. Inspect the Wire: Before use, run a gauze sponge along it; if it snags, it’s sharp. Check for defects.

12. FAQs

1. Why use a Gigli saw instead of a power saw?
For limited access, safety in re-operations where anatomy is distorted, or when a power source is unavailable. It offers superior control in tight spaces.

2. Can a Gigli saw cut through any bone?
Yes, but with considerable effort on very dense, thick cortical bone (e.g., healthy adult femur). It is most efficient on cancellous or smaller bones.

3. How many times can a reusable Gigli saw be used?
There is no set number. It depends on use, bone density, and care during reprocessing. It must be inspected before every use and replaced at the first sign of fraying, kinking, or dullness.

4. What happens if the wire breaks during surgery?
Remain calm. Retrieve both ends if possible. The broken ends are very sharp—handle with care. Replace with a new saw. Ensure all fragments are accounted for to prevent retained foreign body.

5. Is special training needed to use it?
Yes. It is a skill-based instrument. Surgeons learn through supervised practice in training programs or surgical skills labs.

6. Can it be used in pediatric surgery?
Yes, shorter-length saws are available and are useful in pediatric orthopedics and neurosurgery.

7. How do you choose the correct length?
Select a length that allows the wire to comfortably encircle the bone with enough extra at the ends to attach handles and allow for a full pulling stroke without the handles entering the wound.

8. What’s the difference between a Gigli saw and a sternal saw?
A sternal saw is a specialized, powered oscillating saw designed specifically for dividing the sternum. A Gigli saw is a manual, flexible wire used for this and many other bones.

9. Are disposable Gigli saws as good as reusable ones?
Modern single-use saws are of high quality, guaranteed sharp and sterile for each use, and eliminate cross-contamination risk. They are clinically equivalent or superior in performance for that single procedure.

10. How should the saw be passed behind the sternum in cardiac surgery?
A specific, blunt-tipped sternal passer is used under direct visualization and gentle guidance from the assistant’s fingers behind the sternum to protect the underlying heart and great vessels.

13. Conclusion

The Gigli saw is a quintessential example of surgical elegance through simplicity. Despite the proliferation of advanced powered instrumentation, this century-old tool maintains a vital, non-negotiable role in the modern surgeon’s armamentarium. Its value lies in its unparalleled flexibility, reliability, and safety profile in anatomically challenging scenarios. Mastery of the Gigli saw remains a fundamental surgical skill, underscoring the principle that in medicine, the most appropriate technology is not always the most complex, but the one that most reliably and safely achieves the desired outcome. Understanding its proper applications, technical nuances, and safety protocols is essential for the surgical teams that rely on it.

14. References

1. Gigli, L. (1894). Über ein neues Instrument zum Durchtrennen der Knochen, die Drahtsäge. (On a new instrument for cutting bones, the wire saw). Zentralblatt für Chirurgie.
2. American College of Surgeons. (2020). Surgical Instrumentation: An Interactive Guide. https://www.facs.org/education/division-of-education/publications/rise/instrumentation/
3. U.S. Food and Drug Administration. (2023). Classify Your Medical Device. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
4. European Commission. (2017). Regulation (EU) 2017/745 on medical devices (MDR).
5. Kohanzadeh, S., & Laguna, P. (2018). Surgical Instruments: A Practical Guide. Elsevier.
6. Phillips, N., & Hornacky, A. (2021). Berry & Kohn’s Operating Room Technique (15th ed.). Mosby.
7. International Organization for Standardization. ISO 13485:2016 Medical devices — Quality management systems.
8. Industry reports and product catalogs from Integra LifeSciences, B. Braun, Medtronic, and Cardinal Health (2022-2024).