Instruments Set for TENS Nails Type II – Pediatric ESIN Fixation and Removal

Instruments Set for TENS Nails Type II, SKU PS-OP-5359, is a 26-instrument German-forged stainless steel orthopedic system supplied with a container for elastic stable intramedullary nailing. The PS-150 composition includes a hammer, sliding hammer, straight and bevelled elastic-nail impactors, 4.5 mm pin wrench, awl, nail plier, inserter, triangular end-cap wrench, end-cap driver, elastic-nail cutter, two 2.7 mm × 125 mm plain-shank drill bits with Jacobs chuck ends, two 3.2 mm × 145 mm quick-coupling drills, two 4.5 mm × 145 mm quick-coupling drills, 4.5/3.2 mm double drill guide, small F reduction tool, 180 mm curved awl for clavicular fractures, three adjustable reductors, rotatable cutter wrench, inserter key, and hammer guide. Pediatric orthopedic and trauma surgeons use the set for Titanium Elastic Nail System and elastic stable intramedullary nailing procedures involving selected femoral, tibial, humeral, radial, and ulnar shaft fractures, together with elastic fixation of midshaft clavicular fractures. It supports fracture reduction, cortical entry preparation, nail capture, canal advancement, impaction, end trimming, end-cap placement, and implant extraction in pediatric trauma centers, orthopedic hospitals, and ambulatory operating rooms.

Controlled Insertion, End-Cap Placement, and Extraction

The inserter captures the flexible nail and maintains axial and rotational control as the prebent implant crosses the fracture and advances through the medullary canal. Its key secures or releases the clamping interface without substituting plier pressure at the handle. The straight impactor transfers hammer force along an accessible nail end, while the bevelled geometry permits final seating when the terminal segment lies close to the cortical entry. The hammer guide constrains the striking axis so force passes into the selected impactor rather than across the surrounding exposure. After trimming, the triangular wrench and dedicated driver engage the matching end-cap interface for controlled placement and final tightening. The cutter severs the external nail segment, and its rotatable wrench positions or actuates the cutting mechanism where direct handle clearance is restricted. During implant removal, the elastic-nail plier grips the exposed terminal portion and the sliding hammer converts travel of its mass into repeated reverse axial impulses. The 4.5 mm pin wrench supplies rotational leverage at a compatible instrument interface. Awls establish cortical access, the double drill guide stabilizes powered entry preparation, and the F tool plus adjustable reductors apply localized leverage to correct displacement before or during passage. Each mechanism preserves a defined direction of force across insertion, seating, terminal management, and extraction.

Elastic Stable Intramedullary Nailing Workflow

For pediatric femoral and tibial shaft fractures, the surgeon restores length, alignment, and rotation under fluoroscopy before planning paired cortical entries away from the physis. The small F tool or one of three adjustable reductors addresses persistent translation and angulation while maintaining the minimally invasive approach. An awl or a guided 3.2 or 4.5 mm drill creates the portal, after which the inserter advances each prebent elastic nail alternately across the fracture to establish balanced three-point fixation. Controlled hammering through the straight impactor supports canal progression; the bevelled pattern manages the final exposed segment near the cortex. In humeral shaft fixation, entry direction is selected with attention to the radial nerve and growth plate. Radius and ulna procedures require narrower access, careful rotational control, and maintenance of the planned intramedullary trajectory across both bones. The 180 mm curved awl follows the clavicle’s S-shaped anatomy during elastic intramedullary fixation of selected displaced midshaft fractures. Once fluoroscopy confirms reduction, nail depth, and terminal position, the cutter shortens the implant and the end-cap instruments complete the compatible construct. After fracture union and a documented removal decision, the plier secures the exposed end while the sliding hammer delivers controlled extraction along the nail axis.

Drill Sizes, Reduction Tools, and Selection Rationale

Two 2.7 mm × 125 mm plain-shank drills provide narrow cortical access through a Jacobs chuck for smaller pediatric anatomy, including selected radius, ulna, and humeral entry sites. The paired 3.2 mm × 145 mm quick-coupling bits add reach and rapid powered-instrument exchange for intermediate portals in the femur or tibia. Two 4.5 mm × 145 mm quick-coupling drills create a broader opening when required by cortical thickness, nail dimensions, and the operative technique. The 4.5/3.2 mm double guide centers either corresponding diameter, controls surface skiving, and maintains the intended angle away from the physis. A standard awl supports direct manual entry, whereas the 180 mm curved design aligns with the clavicular canal. The small F tool supplies focused reduction leverage; three adjustable reductors permit controlled correction at different working positions without repeatedly changing the exposure. The 4.5 mm pin wrench and inserter key operate their corresponding interfaces, while straight or bevelled impactor selection depends on terminal orientation and remaining clearance. End-cap wrench and driver are reserved for the compatible closure stage. The elastic-nail plier and sliding hammer form the extraction assembly, and the cutter with its rotatable wrench manages the external implant segment. Duplicate drill bits support intraoperative readiness and set continuity.

German Stainless Steel, Reprocessing, and Linked Procurement

German-forged stainless steel provides the hardness needed at drill flutes, awl points, driver interfaces, gripping jaws, and cutter faces while retaining toughness under manual torsion and impaction. Its corrosion resistance supports repeated point-of-use soil removal, cleaning, rinsing, drying, inspection, packaging, and steam sterilization within a validated reusable-instrument process. The satin finish reduces glare beneath operating lights and helps sterile-processing staff detect residue, pitting, bent shafts, blunt points, damaged couplings, or jaw misalignment. Hinged and adjustable components are opened during cleaning; drill flutes, guide channels, the inserter clamp, cutter mechanism, and sliding-hammer surfaces receive direct brushing or flushing. The set is supplied non-sterile and requires reprocessing before initial and subsequent procedures. CE documentation supports applicable European conformity assessment, and ISO 13485 identifies manufacture under a medical-device quality management system; US procurement evaluates FDA classification, registration, listing, labeling, and importer records separately. Related catalog pathways retained from the current page include the Knee Osteotomy Plates System Instruments Set, Distal Radius 2.4 or 2.7 mm Plates, Side-Perforated Woven Sterilization Baskets, and Poole Abdominal Suction Tubes.

Products Specification 

How does the Type II set differ from the PS-149 TENS Nails Instruments Set?
The Instruments Set for TENS Nails Type II adds dedicated end-cap, reduction, and cutter-control components to the elastic-nailing workflow. The PS-149 TENS Nails Instruments Set provides the principal entry, insertion, impaction, trimming, and extraction instruments. Type II includes a triangular end-cap wrench, end-cap driver, rotatable cutter wrench, inserter key, and three adjustable reductors. It also supplies two units each of the 2.7, 3.2, and 4.5 mm drill bits for intraoperative continuity. Both systems use straight and bevelled impactors, an inserter, awl-based entry preparation, reduction instrumentation, and nail-extraction controls. Selection therefore depends on the compatible implant system and whether the planned construct requires the Type II end-cap and adjustable-reduction workflow.

How are the 2.7, 3.2, and 4.5 mm drill bits selected?
Selection follows cortical thickness, patient size, planned nail dimensions, entry-site anatomy, and the operative technique. The 2.7 mm × 125 mm plain-shank drill provides a narrower portal for selected pediatric radius, ulna, or humeral procedures. The 3.2 mm × 145 mm quick-coupling option offers greater reach for intermediate femoral or tibial entry preparation. The 4.5 mm × 145 mm drill creates a broader cortical opening when required by larger adolescent anatomy or the selected elastic-nail construct. The 4.5/3.2 mm double guide stabilizes the matching powered bit and directs it away from the physis. Within the Instruments Set for TENS Nails Type II, the surgeon relates diameter choice to the entry trajectory and compatible implant technique rather than bone name alone.

What do CE, ISO 13485, and FDA requirements mean for procurement?
CE documentation addresses applicable European conformity requirements for the Instruments Set for TENS Nails Type II. ISO 13485 identifies the quality management system governing medical-device manufacture, traceability, controlled records, and corrective action. Neither designation represents United States FDA approval. US hospitals and distributors evaluate the relevant device classification, establishment registration, listing, labeling, importer, and shipment documentation. Procurement teams retain the quotation, SKU, instructions for use, lot or batch identification, and supplied conformity records. This approach keeps European, US, Pakistani, Vietnamese, and other international purchasing pathways correctly separated.

How are the inserter key, end-cap controls, and sliding hammer used?
The inserter key secures or releases the nail within the inserter’s clamping mechanism while maintaining the planned rotational orientation. Straight or bevelled impactors then transfer controlled hammer force to the exposed terminal segment. After nail depth and length are accepted, the cutter and rotatable wrench manage trimming where direct handle clearance is restricted. The triangular wrench and dedicated driver engage the compatible end cap during closure of the implant construct. For later extraction, the nail plier clamps the exposed end and preserves the pulling axis. The sliding hammer applies repeated reverse axial impulses, allowing the Instruments Set for TENS Nails Type II to retrieve the implant without levering the plier against the cortical margin.

How should the complete Type II set be reprocessed and counted?
The Instruments Set for TENS Nails Type II is supplied non-sterile and requires reprocessing before first use and after every procedure. Staff separate detachable interfaces, open hinged or adjustable mechanisms, and remove gross soil before residue dries. Drill flutes, guide bores, gripping jaws, cutter surfaces, inserter interfaces, and sliding parts receive direct cleaning and inspection. The 26 operative pieces and container are reconciled against the PS-150 table, including two units of each drill size and three adjustable reductors. After rinsing and complete drying, the organized case is packaged and steam sterilized under the facility’s validated cycle for reusable stainless steel instrumentation. Procurement and operating-room teams use the individual PS-150 codes for replenishment, service communication, and traceable set control.