Large Fragment Safety Lock Instruments Set – 4.3mm Drilling & Torque Control

Large Fragment Safety Lock Instruments Set, SKU PS-OP-1654, is a reusable orthopedic fixation instrument set manufactured in German stainless steel and configured for preparation and insertion of compatible large-fragment safety-lock screws. The core configuration contains two PS435.002 calibrated Ø4.3mm, 221mm, two-flute quick-coupling drill bits, a PS435.006 4.3mm drill sleeve for 5.0mm safety-lock screws, a PS435.010 torque-limiting screwdriver with 3.5mm tip, a PS435.014 T-handle for quick coupling, two PS435.018 HSS Ø3.5mm drill bits with blue coating, a PS435.022 conical left-hand-thread extraction screw for Ø4.5–6.5mm screws, a PS435.002 Ø2.0mm Kirschner-wire centering sleeve with 125mm length, and a PS435.030 empty container. Optional components extend the configuration with cannulated drilling and threaded sleeves for 7.3mm cannulated cancellous-lock screws, 5.0mm cannulated-lock screws and 6.5mm cancellous-lock screws. The system is intended for orthopedic trauma surgeons performing large-fragment locking plate fixation, including fracture fixation of long bones and metaphyseal regions, in hospitals, trauma centers, orthopedic operating rooms and medical procurement environments.

Calibrated Drilling and Safety-Lock Screw Preparation

The core drilling mechanism is centered on the calibrated Ø4.3mm drill bit and matching 4.3mm drill sleeve. The 221mm two-flute geometry provides a long working length for controlled access to large-fragment locking holes, while the quick-coupling end interfaces directly with the compatible T-handle or powered handpiece. The 4.3mm drill sleeve establishes the drilling axis for compatible 5.0mm safety-lock screws and maintains a defined relationship between the drill and plate hole. The torque-limiting screwdriver uses a 3.5mm tip to engage the compatible screw interface and provides controlled torque transmission during final screw insertion. The T-type quick-coupling handle supplies manual rotational control for compatible instruments. The Ø3.5mm HSS drill bits provide a separate drilling diameter and are supplied with a blue coating for their designated configuration. The Ø2.0mm Kirschner-wire centering sleeve establishes a controlled central pathway for compatible guide-wire positioning. For implant removal, the conical left-hand-thread extraction screw engages compatible Ø4.5–6.5mm screws when conventional screwdriver engagement is unavailable. These components create a defined sequence from drill alignment and hole preparation through torque-controlled screw insertion and extraction.

Large-Fragment Locking Plate Fixation Workflow

The set supports the instrument stages associated with large-fragment safety-lock plate fixation after fracture reduction and plate positioning. The surgeon first establishes the plate position and selects the compatible locking-hole location according to the fixation construct. The PS435.006 drill sleeve is placed through the compatible plate interface to establish the trajectory for the Ø4.3mm calibrated drill. The 221mm drill bit then prepares the bone through the sleeve while maintaining the intended axis. After drilling, the compatible locking screw is introduced using the 3.5mm torque-limiting screwdriver, allowing controlled application of the specified insertion torque for the compatible implant system. The T-handle provides manual control when the selected instrument is used with a quick-coupling interface. The Kirschner-wire centering sleeve supports guide-wire-centered preparation where compatible instrumentation requires it. The optional cannulated drill and threaded sleeve components expand the set for 7.3mm cannulated cancellous-lock screws, 5.0mm cannulated-lock screws and 6.5mm cancellous-lock screws. The extraction screw provides a dedicated removal interface for compatible Ø4.5–6.5mm screws with damaged or inaccessible drive interfaces. This configuration is intended for orthopedic trauma procedures using compatible large-fragment safety-lock plates and screw systems rather than for general-purpose drilling.

Core and Optional Instrument Configurations

The core PS-OP-1654 configuration contains two calibrated Ø4.3mm drill bits, providing a working duplicate for the principal 5.0mm safety-lock screw preparation pathway. The 4.3mm drill sleeve is dedicated to 5.0mm safety-lock screws and establishes controlled drill alignment. The torque-limiting screwdriver with 3.5mm tip provides the final screw-driving interface, while the T-type quick-coupling handle supplies manual actuation for compatible instruments. Two Ø3.5mm HSS drill bits provide the secondary drilling configuration and use a blue coating specified on the product page. The conical left-hand-thread extraction screw is intended for compatible Ø4.5–6.5mm screws during removal. The Ø2.0mm Kirschner-wire centering sleeve, 125mm long, supports centered guide-wire positioning. Optional PS435.034 and PS435.038 components add a Ø5.0mm cannulated drill and threaded sleeve for 7.3mm cannulated cancellous-lock screws. PS435.042 and PS435.046 provide the Ø4.3mm cannulated drill and threaded sleeve for 5.0mm cannulated-lock screws. PS435.050 and PS435.054 provide a threaded sleeve and Ø4.3mm drill configuration for 6.5mm cancellous-lock screws. The empty container organizes the supplied core instrumentation for storage and sterile-processing preparation.

German Stainless Steel, Reprocessing and Procurement

The Large Fragment Safety Lock Instruments Set is configured as reusable orthopedic instrumentation for repeated handling, cleaning, inspection and sterilization in professional surgical environments. German stainless steel provides the structural material for the reusable instrument bodies and interfaces, while the listed Ø3.5mm HSS drill bits use the specified blue coating for their drilling configuration. Reusable components should undergo point-of-use cleaning, decontamination, inspection, drying, packaging and validated sterilization according to applicable manufacturer instructions and the healthcare facility's sterile-processing protocol. Steam autoclave sterilization is appropriate for compatible reusable components when performed using a validated cycle. Cutting edges, drill flutes, sleeves, screwdriver tips and extraction threads should be inspected after reprocessing for damage, deformation or retained debris before reuse. Peak Surgicals supports medical procurement through CE marking, ISO 13485 quality-management certification and FDA-compliant procurement support for applicable healthcare markets. The current product page lists the Large Fragment Safety Lock Instruments Set at $936.09 USD and displays three product images. The configuration is suited to orthopedic trauma departments, hospitals, clinics and distributors requiring dedicated safety-lock drilling, torque-controlled screw insertion and compatible screw-removal instrumentation.

Large Fragment Safety Lock Instruments Set

Details of Large Fragment Safety Lock Instruments Set is Given Below.

How does the Large Fragment Safety Lock Instruments Set differ from a standard large-fragment instrument set?
The Large Fragment Safety Lock Instruments Set is focused on safety-lock screw preparation and controlled insertion. It includes a dedicated 4.3mm drill sleeve for 5.0mm safety-lock screws. It also includes a torque-limiting screwdriver rather than relying solely on a conventional fixed screwdriver. The set provides a dedicated extraction screw for compatible Ø4.5–6.5mm screws. Optional cannulated drilling components extend compatibility to additional locking-screw configurations. A conventional large-fragment set may emphasize standard cortex and cancellous screw drilling and tapping rather than this safety-lock-specific interface.

When is the 4.3mm drill selected for large-fragment safety-lock fixation?
The supplied Ø4.3mm calibrated drill is paired with the 4.3mm drill sleeve for compatible 5.0mm safety-lock screws. The sleeve establishes the drilling axis through the compatible plate interface. The 221mm drill length provides access for deep large-fragment fixation sites. The Ø3.5mm HSS drill is a separate drilling configuration and is not simply interchangeable with the 4.3mm safety-lock pathway. Optional Ø4.3mm cannulated drilling is available for compatible 5.0mm or 6.5mm locking-screw configurations. Final selection follows the compatible plate and screw system.

What do CE, ISO 13485 and FDA procurement support mean for this instrument set?
The Large Fragment Safety Lock Instruments Set is supplied within Peak Surgicals' medical-device quality and procurement framework. CE marking addresses applicable European conformity requirements. ISO 13485 relates to the manufacturer's medical-device quality-management system. FDA-compliant procurement support is relevant to applicable US healthcare purchasing workflows. Hospitals and distributors can use the associated regulatory documentation during supplier qualification and procurement review. Destination-market requirements continue to apply to the clinical use and procurement of orthopedic devices.

How does the torque-limiting screwdriver function during safety-lock screw insertion?
The torque-limiting screwdriver uses a 3.5mm tip to engage the compatible screw drive interface. Its torque-control mechanism is intended to limit applied insertion torque according to the compatible implant system's specified value. The screwdriver is used after the prepared hole and locking trajectory have been established. The T-type quick-coupling handle provides manual control for compatible quick-coupling instruments. The torque-limiting interface helps standardize final tightening when used according to the applicable implant technique. The selected torque setting must correspond to the compatible screw system rather than being inferred from the instrument alone.

Is the Large Fragment Safety Lock Instruments Set suitable for hospital sterilization and procurement?
The Large Fragment Safety Lock Instruments Set is configured as reusable orthopedic instrumentation for professional surgical use. Reusable components should undergo cleaning, inspection, drying, packaging and validated sterilization according to the healthcare facility's reprocessing protocol and applicable manufacturer instructions. Steam autoclaving is used for compatible reusable components under a validated cycle. Drill flutes, sleeves, screwdriver tips and extraction threads should be inspected after each processing cycle. The empty container provides organized storage for the core PS435 configuration. The set has an MOQ of one set and is suitable for hospital, trauma-center, orthopedic-clinic and distributor procurement.