Large Fragment Instruments Set – 3.2/4.5mm Drilling & 4.5/6.5mm Tapping

Large Fragment Instruments Set, SKU PS-OP-4157, is a reusable orthopedic fracture-fixation instrumentation system manufactured in German stainless steel and configured as the PS.010 large-fragment system. The set contains a Neutral & Loaded Drill Guide Ø3.2, Drill & Tap Guide Ø4.5/Ø6.5, Drill & Tap Guide Ø3.2/Ø4.5, two Ø4.5 x 115mm drill bits, two Ø3.2 x 115mm drill bits, a 4.5mm cortex-screw tap, 6.5mm cancellous-screw tap, 0–90mm depth gauge, 15mm and 8mm periosteal elevators, 230mm oblique reduction forceps, 200mm sharp reduction forceps, 3.5mm hexagonal screwdriver with silicon handle, two 270mm self-centering bone-holding forceps, paired 18mm/40mm retractors, Ø8.0 countersink, Ø8.0 hollow mill reamer, conical 3.5mm hexagonal extraction screw, two bending irons and a T-type quick-coupling handle. The instrumentation supports orthopedic trauma surgeons performing open reduction and internal fixation with large-fragment plates and 4.5mm cortex or 6.5mm cancellous screws. It is suited to long-bone fracture fixation, including femoral, tibial and humeral plate osteosynthesis, in trauma hospitals, orthopedic operating rooms and fracture-fixation centers.

Drilling, Tapping and Screw Preparation Geometry

The PS.010 configuration is arranged around the preparation sequence for large-fragment screw fixation. The Neutral & Loaded Drill Guide Ø3.2 provides controlled positioning for the 3.2mm drill, allowing neutral drilling or compression-oriented loading according to the selected plate-hole technique. The Drill & Tap Guide Ø3.2/Ø4.5 combines the drilling and tapping pathway used for compatible 4.5mm cortex screws, while the Ø4.5/Ø6.5 guide supports preparation associated with 6.5mm cancellous fixation. The Ø3.2 x 115mm drill bits establish pilot holes for compatible cortex-screw preparation, whereas the Ø4.5 x 115mm drills provide the larger channel required for the compatible cancellous-screw pathway. The 4.5mm cortex tap cuts the internal thread required for a compatible cortex screw when tapping is indicated, while the 6.5mm cancellous tap prepares the corresponding cancellous pathway. The Ø8.0 countersink creates a suitable seat for compatible screw heads, and the 0–90mm depth gauge measures prepared-hole depth before screw selection. The 3.5mm hexagonal screwdriver transfers controlled rotational force to compatible screw interfaces, while the T-type quick-coupling handle provides a manual interface for compatible drilling and tapping instruments.

Large-Fragment Plate Fixation Workflow

The instrumentation supports open reduction and internal fixation workflows in which large-fragment plates are applied to long-bone fractures. Following exposure and fracture reduction, the 15mm and 8mm periosteal elevators assist with controlled tissue and periosteal elevation, while the 18mm/40mm retractors maintain access to the operative field. The 230mm oblique reduction forceps and 200mm sharp reduction forceps provide controlled fragment manipulation during reduction, while the two 270mm self-centering bone-holding forceps maintain purchase on larger bone segments. After reduction, the selected large-fragment plate is positioned and shaped with the paired bending irons where compatible plate contour adjustment is required. The drill guide is then placed over the selected plate hole and the appropriate Ø3.2mm or Ø4.5mm drill is advanced through the guide. The corresponding cortex or cancellous tap prepares the screw pathway when tapping is required. The 0–90mm depth gauge measures the prepared hole, followed by countersinking where compatible with the screw design. The 3.5mm hexagonal screwdriver then inserts the selected screw. The extraction screw and Ø8.0 hollow mill provide dedicated instrumentation for controlled removal of compatible large-fragment screws when required.

PS.010 Components and Their Surgical Roles

The PS.010 set contains a defined group of large-fragment fixation instruments. PS.010.01 provides the Ø3.2 Neutral & Loaded Drill Guide for controlled plate-hole preparation. PS.010.02 and PS.010.03 provide combined drilling and tapping guidance for Ø4.5/Ø6.5 and Ø3.2/Ø4.5 pathways. Two PS.010.04 Ø4.5 x 115mm drills and two PS.010.05 Ø3.2 x 115mm drills provide the principal drilling diameters. PS.010.06 and PS.010.07 provide dedicated taps for 4.5mm cortex and 6.5mm cancellous screws. PS.010.08 measures screw depth from 0–90mm. The 15mm and 8mm elevators support exposure, while the oblique and sharp reduction forceps provide fragment control. Two self-centering bone-holding forceps maintain controlled bone purchase during reduction. The paired 18mm/40mm retractors maintain the operative corridor. PS.010.16 countersinks an Ø8.0 screw-head seat, while PS.010.17 provides an Ø8.0 hollow mill for compatible screw removal. PS.010.18 provides conical extraction engagement, PS.010.19 provides two bending irons for compatible plate shaping, and PS.010.20 provides the T-type quick-coupling interface. The PS.010.000 empty container with screw rack organizes the complete set for storage and sterile-processing preparation.

German Stainless Steel, Reprocessing and Procurement

The Large Fragment Instruments Set is manufactured in German stainless steel for reusable orthopedic instrumentation exposed to repeated mechanical handling, cleaning, inspection and sterilization. Stainless steel provides the mechanical substrate required for drill bits, taps, guides, reduction forceps, bone-holding forceps, screwdrivers, bending instruments and extraction components used during fracture fixation. The set is supplied with an empty container and screw rack to organize the instrumentation during storage, transport and sterile-processing preparation. Reprocessing should include point-of-use cleaning, decontamination, inspection, drying, packaging and sterilization according to the healthcare facility's validated protocol and applicable manufacturer instructions. Steam autoclave sterilization is appropriate for compatible reusable stainless steel instruments when processed using a validated cycle. Peak Surgicals supports medical-device procurement through CE marking, ISO 13485 quality-management certification and FDA-compliant procurement support for applicable healthcare markets. The current product page lists the PS-OP-4157 set at $1,087.89 USD and identifies it as a medical-grade reusable large-fragment instrumentation configuration. The system is suitable for orthopedic trauma departments, hospitals, clinics and medical distributors requiring dedicated large-fragment drilling, tapping, reduction, plate contouring and screw-management instrumentation.

Large Fragment Instruments Set

Details of Large Fragment Instruments Set is Given Below.

How does the PS.010 Large Fragment Instruments Set differ from a small-fragment fixation set?
The PS.010 Large Fragment Instruments Set is configured for 4.5mm cortex and 6.5mm cancellous screw preparation. Its primary drilling diameters are Ø3.2mm and Ø4.5mm. It includes dedicated taps for both screw types and a 0–90mm depth gauge for large-fragment screw measurement. The set also includes self-centering bone-holding forceps and paired bending irons for larger fracture fragments and compatible plate contouring. A small-fragment system uses smaller drill, tap and screw interfaces. The PS.010 configuration therefore matches the preparation requirements of large-fragment plate fixation.

When is the Ø3.2mm drill used instead of the Ø4.5mm drill?
The Ø3.2mm drill is used for preparation associated with compatible 4.5mm cortex screws. The Ø4.5mm drill is used for the larger preparation pathway associated with compatible 6.5mm cancellous screws. The Ø3.2/Ø4.5 Drill & Tap Guide maintains the drilling relationship for the cortex-screw pathway. The Ø4.5/Ø6.5 guide provides the corresponding guidance for the larger cancellous-screw pathway. The appropriate tap is selected after drilling when the fixation technique requires tapping. Final screw and instrument selection follows the compatible plate and screw system.

What do CE, ISO 13485 and FDA procurement support mean for this set?
The PS.010 Large Fragment Instruments Set is supplied through 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 available regulatory documentation during supplier qualification and purchasing review. Product and regulatory records should be retained according to the purchasing institution's requirements.

How do the drill guides, reduction forceps and quick-coupling handle function during fixation?
The Neutral & Loaded Drill Guide controls drill positioning according to the selected plate-hole technique. The Drill & Tap Guides maintain alignment between drilling and tapping instruments. The oblique and sharp reduction forceps provide controlled manipulation of fracture fragments during reduction. The self-centering bone-holding forceps maintain purchase on larger bone segments while the plate is positioned. The T-type Quick Coupling Handle accepts compatible instruments and transfers manual rotational force during preparation. Together these components establish the mechanical sequence from reduction and plate positioning through controlled screw-hole preparation.

Is the PS.010 Large Fragment Instruments Set suitable for hospital sterilization and procurement?
The PS.010 Large Fragment Instruments Set is configured as reusable orthopedic instrumentation for professional surgical use. 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 stainless steel components under a validated cycle. The Empty Container with Screw Rack provides organized storage for the complete instrumentation set. The configuration includes drilling, tapping, reduction, measurement, plate contouring and compatible screw-removal instruments. The set is suitable for hospital, trauma-center, orthopedic-clinic and medical-distributor procurement.