4.5mm/5mm Large Fragment Locking Instrument Set – Combined LCP & AO Basic Trauma System

Heavy-Duty Surgical Instrumentation for 5.0mm Locking Compression (LCP), 4.5mm Dynamic Cortical Compression, and 6.5mm Cancellous Long Bone Osteosynthesis.

Engineered for hospital trauma centers, orthopedic specialty hospitals, and global surgical distributors, Vast Ortho 4.5mm/5mm Large Fragment Locking Instrument Set delivers uncompromising mechanical stability for high-energy long bone fractures. Configured as a unified Orthopedic Large Bone Trauma Instrument Set, this modular platform consolidates the heavy-duty reduction clamps, retractors, and articulated compression tools of an AO Large Fragment Basic Instrument Set with the threaded drill guides and calibrated torque control of a modern Large Fragment LCP Instrument Set into one streamlined sterile layout.

All-in-One Combi-Hole & Standard Plate Compatibility: Purpose-built as a complete 4.5mm Broad and Narrow LCP Instrument System, supporting 4.5mm/5.0mm Broad and Narrow Locking Compression Plates (LCP), Limited-Contact Dynamic Compression Plates (LC-DCP), 1/2 Tubular Plates, and 4.5mm Reconstruction Plates.
Triple-Diameter Hardware Support (4.5mm, 5.0mm & 6.5mm): Operates as a full 4.5mm / 6.5mm Cortical and Cancellous Instrument Set alongside 5.0mm locking hardware—supporting Ø 5.0mm locking screws (Ø 4.3mm calibrated drill), Ø 4.5mm cortex screws (Ø 3.2mm pilot / Ø 4.5mm gliding drill), and Ø 6.5mm cancellous lag screws.
Calibrated Torque Control: Supplied with factory-calibrated click-release torque-limiting power 3.5mm Hexagonal drive connections to guarantee rigid large-fragment screw locking without cold-welding.
Complete Long Bone & Joint-Adjacent Coverage: Engineered to function simultaneously as a Femur, Tibia, and Humerus Locking Plate Instrument Set and a Large Fragment Periarticular and Diaphyseal Locking System.
Regulatory & Material Assurance: Manufactured under ISO 13485:2016 certified quality management systems using stainless steel with medical silicone ergonomics.

Complete 4.5mm/5mm Large Fragment Locking Instrument Set in an anodized large fragment trauma instrument tray

Standard Set Configuration (4.5mm/5mm Large Fragment Locking Instrument Set)

Below is the standard factory configuration for the 4.5mm/5mm Large Fragment Locking Instrument Set. Custom tray configurations, additional screw caddies, and OEM private-label laser marking are available upon request.

Allen Key for Dill Bit Stopper : 1 Qty
Countersink for 4.5/6.5mm Screws : 1 Qty
Depth Gauge Measuring range upto 110 mm : 1 Qty
Double Drill Sleeve (Universal Drill Sleeve) 3.2/4.5 mm : 1 Qty
Double Drill Sleeve (Universal Drill Sleeve) 3.2/6.5 mm : 1 Qty
Drill Bit 3.2 mm x 130 mm Quick Coupling : 2 Qty
Drill Bit 4.5 mm x 130 mm Quick Coupling : 2 Qty
Drill Bit 4.3 mm x 220 mm with Stopper, Quick Coupling : 2 Qty
Drill Guide 4.5 mm for Neutral and Load Position : 1 Qty
Guide Sleeve for 2 mm K Wires : 1 Qty
Guide Wire Threaded Trocar 2 mm x 280 mm : 5 Qty
Hohmann Retractor 25 mm : 2 Qty
Insert Drill sleeve 4.5/3.2 mm : 1 Qty
Periosteal Elevator Fiber Handle 5 mm : 1 Qty
Periosteal Elevator Fiber Handle 10 mm : 1 Qty
Plate Bender : 2 Qty
Plate Bending Template : 3 Qty
Reduction Forcep Pointed Ratchet Lock 200 mm : 1 Qty
Reduction Forcep Serrated Ratchet Lock 200 mm : 1 Qty
Self Centering Bone Holding Forcep Speed Lock 250 mm : 2 Qty
Screw Extraction T Handle for 5 mm Screws : 1 Qty
Screw Holding Forceps : 1 Qty
Screw Driver Hexagonal, Holding Sleeve, 3.5 mm Tip : 1 Qty
Screw Driver Torque for 5 mm Locking Screws : 1 Qty
Screw Driver Quick Coupling for 5 mm Locking & 4.5 mm Cortical Screws : 1 Qty
Sharp Hook : 1 Qty
T Handle Quick Coupling : 1 Qty
Tap for 4.5 mm Cortical Screws, Quick Coupling : 1 Qty
Tap for 6.5 mm Cancellous Screws, Quick Coupling : 1 Qty
Threaded Drill Guide 5 mm for Drill Bit 4.3 mm : 3 Qty
Trephine T Handle : 1 Qty
Graphics Aluminium Box with Silicone Fittings : 1 Qty

Threaded 5.0mm drill sleeves, Ø 4.3mm calibrated drills, and 4.0 Nm torque limiter in the Large Fragment LCP Instrument Set

Drills, bone taps, and compression guides from the 4.5mm / 6.5mm Cortical and Cancellous Instrument Set

Heavy-duty Verbrugge clamps and articulated tension device in the Femur, Tibia, and Humerus Locking Plate Instrument Set

Orthopedic Large Bone Trauma Instrument Set and 4.5mm Broad and Narrow LCP Instrument System sterilization case

Unified Large Bone Architecture: Combining the 4.5mm/5mm Large Fragment Locking Instrument Set with the AO Large Fragment Basic Instrument Set

High-energy diaphyseal and metaphyseal fractures of the lower and upper extremities require substantial reduction force and versatile fixation options. In conventional hospital inventories, operating room staff must pull a standard AO Large Fragment Basic Instrument Set for interfragmentary lag screws and dynamic compression, plus a separate locking add-on tray for fixed-angle plating.

Our consolidated 4.5mm/5mm Large Fragment Locking Instrument Set eliminates redundant tray processing by housing every reduction, distraction/compression, drilling, tapping, and torque-controlled insertion instrument inside a single, logically indexed Orthopedic Large Bone Trauma Instrument Set. Trauma surgeons gain immediate access to self-centering Verbrugge bone holding forceps, Weber pointed reduction clamps, an articulated tension device, and heavy-duty Hohmann retractors right alongside threaded LCP drill sleeves—enabling seamless intraoperative transitions between classic compression plating and bridged internal fixation via a Large Fragment Periarticular and Diaphyseal Locking System.

Heavy-Duty Combi-Hole Engineering: Large Fragment LCP Instrument Set & 4.5mm / 6.5mm Cortical and Cancellous Instrument Set Capabilities

Coaxial Ø 4.3mm Locking Screw Trajectory: Threaded LCP drill sleeves thread directly into the locking portion of 4.5mm/5.0mm combi-holes and periarticular plate holes, guiding the calibrated Ø 4.3mm drill bit along a dead-center coaxial trajectory.
Dynamic Axial Compression & Articulated Tensioning: Includes both the spring-loaded 4.5mm Universal Neutral/Load Drill Guide and a removable Articulated Tension Device with pressure gauge for compressing or distracting wide diaphyseal fracture gaps across the femur or tibia.
Full 4.5mm / 6.5mm Cortical and Cancellous Instrument Set Integration: Equipped with Ø 3.2mm pilot drills, Ø 4.5mm cortex gliding-hole over-drills, a large fragment cortical countersink, and dedicated Ø 4.5mm cortical and Ø 6.5mm cancellous bone taps for 16mm partial, 32mm partial, and fully threaded 6.5mm metaphyseal lag screws.
3.5mm Hex Drive Interface: Supplied with 3.5mm Hexagonal self-retaining screwdriver shafts and complete manual drivers, ensuring cross-compatibility with standard AO and proprietary large-fragment screw inventories.
Calibrated Torque Limiters: Audible and tactile click-release torque limiters ensure optimal conical head-to-plate thread engagement for 5.0mm locking screws while preventing drive recess stripping or cold-welding.

Multi-Indication Long Bone Fixation: Femur, Tibia, and Humerus Locking Plate Instrument Set

Designed as the primary trauma workhorse for inpatient operating rooms, this set covers the full spectrum of high-energy long bone reconstruction. Functioning as a turnkey Femur, Tibia, and Humerus Locking Plate Instrument Set, it equips orthopedic teams to manage simple transverse shaft fractures, complex wedge fractures, periprosthetic fractures, and comminuted intra-articular splits.

Implant-Matched Versatility: 4.5mm Broad and Narrow LCP Instrument System & Large Fragment Periarticular and Diaphyseal Locking System

Femoral Shaft, Subtrochanteric & Distal Femur Fractures: Operates as a dedicated 4.5mm Broad and Narrow LCP Instrument System for 4.5mm Broad LCP femoral shaft plating, periprosthetic cable-plate fixation, and anatomically pre-contoured 4.5mm/5.0mm Lateral Distal Femur (LISS-style) locking plates.
Tibial Shaft & Tibial Plateau Reconstruction: Supports 4.5mm Narrow LCP diaphyseal tibial plating as well as lateral and medial proximal tibia buttress/locking plates using 5.0mm subchondral raft screws and 6.5mm cancellous lag screws.
Humeral Diaphyseal & Metaphyseal Fractures: Provides narrow self-centering bone holding clamps, soft-tissue radial nerve protection retractors, and heavy-duty bending irons for anterior or posterior 4.5mm Narrow LCP humeral shaft osteosynthesis.

Sterile Processing (SPD) Efficiency: Modular Large Fragment Trauma Instrument Tray

Hospital Sterile Processing Departments (SPD) and operating room managers evaluate surgical systems on sterilization throughput, weight compliance, and visual inventory verification. Our Large Fragment Trauma Instrument Tray is housed in a perforated, hard-anodized aluminum sterilization case with medical silicone brackets.

High-Flow Perforation Geometry: Engineered with open-surface perforation ratio to guarantee rapid steam penetration and moisture evacuation during standard pre-vacuum steam sterilization cycles (132°C / 270°F for 4 minutes).
Ergonomic Modular Split-Tray Design: Large Fragment Trauma Instrument Tray engineered to comply with the 25 lb (11.3 kg) AAMI ST77 weight limit per container by distributing heavy reduction forceps and drilling/tapping modules across balanced, stackable graphic tiers.

Frequently Asked Questions

Q1: Does this 4.5mm/5mm Large Fragment Locking Instrument Set support 3.5mm Hex locking screws?

Yes. Our 4.5mm/5mm Large Fragment Locking Instrument Set includes 3.5mm Hexagonal self-retaining screwdriver shafts and manual drivers alongside a calibrated torque limiter, making it a universally compatible Large Fragment LCP Instrument Set.

Q2: Does this single system replace a separate AO Large Fragment Basic Instrument Set?

Yes. Engineered as a unified Orthopedic Large Bone Trauma Instrument Set, this configuration combines every reduction clamp, Hohmann retractor, articulated tension device, and dynamic compression guide found in an AO Large Fragment Basic Instrument Set with the threaded drill sleeves and calibrated drills required for 5.0mm locking osteosynthesis.

Q3: Can this tray be used as a 4.5mm / 6.5mm Cortical and Cancellous Instrument Set?

Absolutely. Configured as a comprehensive 4.5mm / 6.5mm Cortical and Cancellous Instrument Set, it contains Ø 3.2mm pilot drills, Ø 4.5mm gliding over-drills, Ø 4.5mm cortical taps, and Ø 6.5mm cancellous bone taps—enabling surgeons to place 5.0mm locking screws, 4.5mm cortical screws, and 6.5mm metaphyseal cancellous lag screws from one tray.

Q4: What are the sterilization parameters for the Large Fragment Trauma Instrument Tray?

The Large Fragment Trauma Instrument Tray is validated for standard hospital pre-vacuum steam autoclave sterilization at 132°C (270°F) for 4 minutes with a minimum 20–30 minute drying cycle, as well as 134°C (273°F) for 3 minutes under European/WHO protocols.

Q5: Do you offer OEM / Private Label branding for the 4.5mm Broad and Narrow LCP Instrument System?

Yes. We provide comprehensive OEM and private-label manufacturing for orthopedic implant companies and regional distributors. We can customize laser-etched logos, anodized tray colors, silicone bracket layouts, and specific instrument bills of materials (BOM) to match your proprietary 4.5mm Broad and Narrow LCP Instrument System and Large Fragment Periarticular and Diaphyseal Locking System.

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CLINICAL SAFETY & OPERATIONAL PROTOCOL: 4.5MM/5MM LARGE FRAGMENT LOCKING INSTRUMENT SET

Safety, Handling, Cleaning & Sterilization Guide for the Large Fragment LCP Instrument Set, AO Large Fragment Basic Instrument Set, 4.5mm / 6.5mm Cortical and Cancellous Instrument Set, and 4.5mm Broad and Narrow LCP Instrument System

SECTION 01 | PURPOSE, SCOPE & TRAINING REQUIREMENTS

1.1 Why This Protocol Exists

This easy-to-understand Clinical Safety & Operational Protocol establishes mandatory, evidence-based rules for checking, preparing, using, cleaning, sterilizing, and tracking reusable orthopedic instruments and trauma implants. Following these safety steps when operating with the 4.5mm/5mm Large Fragment Locking Instrument Set prevents avoidable surgical harms, including accidental bone fractures, heat death of bone cells (thermal osteonecrosis), broken metal pieces left inside the patient, stripped screw heads, cross-infection, galvanic corrosion, and early metal fatigue.

1.2 Scope of Instruments & Implants Covered

This protocol applies to all reusable manual, modular, hollow (cannulated), impact, and power-assisted tools across the Large Fragment LCP Instrument Set, the AO Large Fragment Basic Instrument Set, the 4.5mm / 6.5mm Cortical and Cancellous Instrument Set, and the 4.5mm Broad and Narrow LCP Instrument System:

Cutting, Reaming & Bone Prep Tools: Drills, taps, osteotomes, chisels, gouges, rasps, broaches, bone awls, oscillating saw blades, and intramedullary or acetabular reamers.
Hollow (Cannulated) & Guided Tools: Cannulated drills, guide wires (Kirschner wires and Steinmann pins), trocars, depth gauges, and radiolucent carbon-fiber targeting frames.
Torque-Limiting & Ratcheting Mechanisms: Calibrated torque-limiting screwdrivers (solid-state and spring-clutch designs), ratcheting handles, and screw reduction towers.
Impaction & Trialing Devices: Slap hammers, bone tamps, impactors, and modular polymer or metal trial components.
Osteosynthesis & Trauma Fixation Implants: Anatomical locking and non-locking bone plates, cortical, cancellous, and cannulated bone screws, Kirschner wires, and cerclage cables supplied in sterile packs or sterilization caddies.

1.3 Load-Sharing Principles & Staff Qualifications

Trauma fixation implants are temporary load-sharing devices built to stabilize fractures only until natural bone healing takes place (typically 8 to 24 weeks). If bone healing is delayed or fails (non-union), repeated weight-bearing stress will eventually break any metal plate, nail, or screw. Only licensed orthopedic surgeons and staff with documented training on assembly, torque limits, and validated cleaning cycles may handle this system.

SECTION 02 | CRITICAL WARNINGS, CONTRAINDICATIONS & MATERIAL CARE

CRITICAL CLINICAL WARNINGS — PATIENT SAFETY MANDATES

Never use dull drills, taps, or blades: Using cutting tools past their sharpness lifespan requires excessive pushing force and heats bone above 47°C (116.6°F), causing permanent bone cell death (thermal osteonecrosis) and later implant loosening.
Never pry or bend with instruments: Hollow drills, taps, osteotomes, and guide wires in the AO Large Fragment Basic Instrument Set are engineered strictly for straight-in-line (coaxial) force. Sideways bending or prying snaps the metal and leaves broken pieces inside the bone.
Never mix brands or dissimilar metals: Never combine tools or implants from different manufacturers, as tiny size differences cause stripped screw heads, cold-welding, and driver slip-out. Never place Stainless Steel screws in direct contact with Titanium plates, which triggers battery-like galvanic corrosion in body fluids.
Strict single-use & zero-scratch rules: Never reprocess disposable K-wires, saw blades, or single-use torque limiters marked “Do Not Reuse”. All implants are strictly single-use; any plate or screw that touches blood, bone, or tissue must never be re-sterilized or put back into an implant caddy. Never grab implants with toothed forceps or bend a plate back and forth (reverse bending), as a single scratch or reverse bend cuts fatigue strength by over 50%.

2.1 When NOT to Use Tools or Implants

Damaged or Uncalibrated Tools: Do not use any tool from the 4.5mm/5mm Large Fragment Locking Instrument Set showing rust, pitting, cracks, a bent shaft, mushroomed hitting ends, burred edges, faded millimeter lines, or expired torque calibration.

Patient Contraindications: Do not implant hardware if the patient has an active local or bloodstream infection (such as osteomyelitis or septic arthritis), a severe allergy to Nickel, Cobalt, or Chromium, weak or osteoporotic bone without bone graft or PMMA cement support, or open pediatric growth plates.

2.2 Care Rules for Different Materials

Stainless Steel: Hardened cutting steel holds a sharp edge but pits easily in salt water, so avoid prolonged saline contact and dry immediately after washing. 316L stainless steel plates and screws must mate only with 316L stainless steel and must never be hammered against hardened steel.

Titanium & Plastics: Keep color-anodized titanium away from bleach, hydrogen peroxide, and alkaline cleaners above pH 9.5. Check plastic guides and trials for surface cracks and never steam-sterilize them above 137°C.

SECTION 03 | PRE-SURGERY CHECKS, TORQUE CALIBRATION & CADDY RULES

3.1 Instrument Inspection (OR Back Table)

Every tool in the 4.5mm / 6.5mm Cortical and Cancellous Instrument Set must be inspected by the Scrub Technologist on the OR back table before skin incision

3.2 Torque-Limiting Drivers & Pre-Op Implant Verification

Torque-Limiting Screwdriver Rules: Small locking screws in the Small Fragment LCP Instrument Set require exact tightening force so threads lock securely without shearing the screw neck. Turn the driver until you feel and hear one clear “click,” then stop immediately. Repeated clicking (“double-clicking”) damages the internal spring clutch and strips or over-torques the small screw.
Implant “Time-Out” & Screw Caddy Care: Verify primary, smaller (-1), and larger (+1) implant sizes 24 hours before surgery. Before opening a sterile implant pouch, the Circulating Nurse, Scrub Tech, and Surgeon must confirm the correct side/size, unexpired date, intact sterile package, chemical indicator color shift, and that the package was never dropped. Keep open screw caddies in a clean back-table zone away from bloody instruments, handle screws with clean forceps, and place any screw that touches blood or bone into a “Discard Basin”—never return it to the caddy.

SECTION 04 | SAFE OPERATING ROOM USE & POINT-OF-USE CARE

4.1 Safe Drilling, Plate Bending & Broken Tool Steps

Drilling, Cooling & Plate Contouring: Thread locking drill sleeves fully into the 4.5mm Broad and Narrow LCP Instrument System plate before drilling and hold the drill straight so it does not shave metal slivers off the guide. Continuously spray cooled sterile 0.9% saline and pull the drill back every 3–5 seconds (“peck drilling”) to keep bone below 47°C. Watch guide wires on X-ray (fluoroscopy) and stop if high resistance is felt. Bend plates smoothly across inter-hole bridges using only system bending irons or presses—never deform a threaded locking hole. Change outer sterile gloves before touching implants, keep implants away from skin edges, and never soak implants in open saline bowls.
If a Tool Breaks During Surgery: (1) Stop immediately and fit broken pieces together on the back table; (2) Take AP and Lateral C-arm X-rays to locate any retained tip; (3) Weigh removal risks versus leaving the fragment in place (if left inside, record its exact position and metal type for future MRI safety and tell the patient).

4.2 Immediate OR Wipe-Down (Within 15–30 Minutes)

Blood, bone marrow, joint fluid, and bone cement harden and start pitting stainless steel within 15 minutes. The Scrub Technologist must wipe tools right after use with sterile sponges soaked solely in sterile water (never use 0.9% saline, which causes rapid salt pitting). Flush hollow tubes with sterile water using a syringe and spray the tray with pH-neutral enzymatic foam or cover with a wet sterile-water towel before transport.

SECTION 05 | CSSD CLEANING, STERILIZATION & STORAGE

5.1 Manual, Ultrasonic & Automated Washing

In CSSD, staff wearing full PPE must take multi-part tools from the Large Fragment LCP Instrument Set completely apart, soak them for 10–15 minutes in warm (30°C–40°C / 86°F–104°F) pH-neutral enzymatic detergent (pH 6.0–8.5), and scrub all teeth, hinges, and flutes completely underwater with soft medical nylon brushes (never metal wire brushes). Brush hollow tubes 3 times, flush with water at 30 PSI for 30 seconds, and clean in a degassed ultrasonic bath at 35–45 kHz for 10 minutes with hinges open. Load trays into an ISO 15883 washer-disinfector with hinges opened to 90° and run all 5 phases: cold pre-wash (<35°C, 3 min), enzymatic/mild alkaline wash (45°C–55°C, 5–10 min, pH 7.0–10.5), warm DI/RO rinse (40°C–50°C, 2 min), thermal disinfection rinse with critical RO/distilled water (90°C–93°C, 5–10 min, A0 at least 3000), and HEPA hot-air drying (90°C–110°C, 15–20 min). Wash implant caddies in separate implant-only loads free of bone debris.

5.2 Lubrication, Steam Autoclaving & Storage

Lubrication & 25-Lb Weight Limit: Apply water-soluble “instrument milk” only to hinges and ratchets—never use silicone or industrial oil. Place two Type 5 chemical indicators in opposite tray corners and keep total tray weight at or below 25 lbs (11.3 kg).
Validated Pre-Vacuum Steam Cycles: Sterilize using Dynamic Air Removal (Pre-Vacuum) steam at 132°C (270°F) for 4 minutes (US standard) or 134°C–137°C (273°F–279°F) for 3 minutes (EU standard) with 30–45 minutes drying (use a 10-minute hold and 45–60 minute dry for heavy loaner sets, or 134°C for 18 minutes for WHO prion cycles). Gravity displacement and “flash” sterilization (IUSS) are strictly prohibited.
Cooling & Storage Room Rules: Cool trays untouched on wire racks for 60–120 minutes away from drafts and completely reprocess any wet pack. Store 4.5mm/5mm Large Fragment Locking Instrument Set trays and implants in a locked, positive-pressure room (+2.5 to +5.0 Pa) at 18°C–24°C (64°F–75°F) and 30%–60% humidity with at least 4 air changes per hour, positioned 8–10 inches above the floor and 18 inches below sprinklers.

4.5mm/5mm Large Fragment Locking Instrument Set – Combined LCP & AO Basic Trauma System

Standard Set Configuration (4.5mm/5mm Large Fragment Locking Instrument Set)

Unified Large Bone Architecture: Combining the 4.5mm/5mm Large Fragment Locking Instrument Set with the AO Large Fragment Basic Instrument Set

Heavy-Duty Combi-Hole Engineering: Large Fragment LCP Instrument Set & 4.5mm / 6.5mm Cortical and Cancellous Instrument Set Capabilities

Multi-Indication Long Bone Fixation: Femur, Tibia, and Humerus Locking Plate Instrument Set

Implant-Matched Versatility: 4.5mm Broad and Narrow LCP Instrument System & Large Fragment Periarticular and Diaphyseal Locking System

Sterile Processing (SPD) Efficiency: Modular Large Fragment Trauma Instrument Tray

Frequently Asked Questions

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