Pre-owned / Used 2002 SYNTHES TitaniumCannulatedNailEXSystem ORTHOPEDIC MANUAL SURGICAL INSTRUMENT for Sale

Hardware Summary

Titanium cannulated nail system with 5.0mm diameter, 300mm length, radiolucent targeting guide, and 12° distal bend for intramedullary fixation of femoral fractures; precision-machined fr...

Software Summary

No integrated software; designed for manual operation with fluoroscopic targeting alignment; compatible with standard OR imaging systems (C-arm, fluoroscopy) for real-time guidance

Accessories Summary

Includes 5.0mm cannulated nail, 4.5mm locking screws (4pcs), targeting guide, insertion handle, depth gauge, and screwdriver set; compatible with Synthes universal drill system and standa...

Hardware

The TitaniumCannulatedNailEXSystem is a pre-owned, pre-sterilized orthopedic intramedullary fixation device manufactured by Synthes, designed for the stabilization of diaphyseal and metaphyseal femoral fractures. The system features a 5.0mm diameter, 300mm length titanium alloy (Ti-6Al-4V ELI) cannulated nail with a 12° distal bend to accommodate femoral anatomy and optimize load distribution. The nail incorporates a radiolucent targeting guide for precise screw placement under fluoroscopic guidance, with a 4.5mm locking screw interface for cortical and cancellous bone fixation. The device is precision-engineered with a ±0.05mm tolerance to ensure optimal fit and alignment during implantation. The cannulated design allows for guide wire placement prior to nail insertion, reducing intraoperative fluoroscopy time. The system is compatible with standard orthopedic power tools (110-240V, 50/60Hz) and universal drill systems, with a maximum torque rating of 4.5 Nm for screw insertion.

Software / Upgrade / OS / Applications / Worklist

The TitaniumCannulatedNailEXSystem is a manual, non-electronic orthopedic instrument designed for use in conjunction with fluoroscopic imaging systems. The device does not incorporate embedded software or digital interfaces; however, it is fully compatible with standard operating room imaging systems, including C-arm fluoroscopy units and portable X-ray machines. The targeting guide is designed for alignment with fluoroscopic imaging, allowing for real-time visualization of screw trajectories and nail positioning. The system supports integration with hospital PACS (Picture Archiving and Communication System) for image storage and retrieval, facilitating postoperative assessment and documentation. The device complies with IEC 60601-1-3 for electromagnetic compatibility and IEC 62304 for medical device software life cycle processes, ensuring safety and reliability in clinical environments.

Accessories

The TitaniumCannulatedNailEXSystem includes a comprehensive accessory kit to support intramedullary fixation procedures. The kit comprises a 5.0mm diameter, 300mm length titanium cannulated nail with a 12° distal bend, four 4.5mm locking screws (two cortical and two cancellous), a radiolucent targeting guide, an insertion handle with a quick-release mechanism, a depth gauge for precise screw length measurement, and a screwdriver set with hexagonal and Phillips drive options. The system is compatible with Synthes universal drill systems (e.g., Synthes Cordless Driver, Synthes Power Tool System) and standard orthopedic power tools with a 4.0mm hex drive. Additional compatible accessories include guide wires (1.6mm diameter), reduction forceps, bone awls, and mallets for nail insertion. The targeting guide is designed for use with 2.5mm and 3.2mm drill bits, with a depth stop feature to prevent over-drilling.

Warranty Inclusions & Exclusions

The TitaniumCannulatedNailEXSystem is offered as a pre-owned device with a limited warranty provided by the seller at an additional cost. The warranty covers manufacturing defects, material failures, and mechanical malfunctions for a period of 12 months from the date of delivery, subject to the terms and conditions outlined in the sales agreement. The warranty does not cover damage resulting from improper use, storage, or handling, including but not limited to corrosion, scratches, or deformation. The seller reserves the right to inspect the device for pre-existing damage prior to warranty activation. In the event of a defect, the seller will provide repair or replacement at their discretion, with shipping costs borne by the buyer. The warranty excludes consumables, such as screws and targeting guides, which are subject to wear and tear. The seller offers optional extended warranty coverage for an additional fee, covering parts and labor for up to 24 months.

Service History

The TitaniumCannulatedNailEXSystem has been professionally serviced and maintained in accordance with Synthes’ recommended protocols. The device has undergone a comprehensive inspection, including dimensional verification, surface finish assessment, and mechanical integrity testing. The service history includes prior use in a controlled clinical environment, with documented adherence to sterilization protocols (ethylene oxide sterilization, ISO 11737-1 compliant). The device has been stored in a dry, temperature-controlled environment (15-25°C, 30-60% humidity) to prevent degradation of the titanium alloy. No evidence of corrosion, pitting, or mechanical wear has been observed during inspection. The targeting guide has been verified for alignment accuracy, with no deviations exceeding ±1° from the manufacturer’s specifications. The insertion handle and screwdriver set have been tested for torque transmission, with no signs of wear or slippage.

Packing List

The TitaniumCannulatedNailEXSystem is supplied in a single, sterile-packaged unit, compliant with ISO 11607 standards for medical device packaging. The primary packaging consists of a medical-grade, tear-resistant pouch with a Tyvek® seal, ensuring a sterile barrier for up to 5 years when stored under controlled conditions. The pouch is labeled with the device name, model number, lot number, expiration date (if applicable), and sterilization method (ethylene oxide). Inside the pouch, the 5.0mm diameter, 300mm length titanium cannulated nail is secured in a custom-molded foam insert to prevent movement and damage during transit. The accessory kit includes four 4.5mm locking screws (two cortical, two cancellous), a radiolucent targeting guide, an insertion handle, a depth gauge, and a screwdriver set, all individually wrapped in sterile pouches. The entire assembly is placed in a rigid, corrugated shipping box with impact-resistant foam padding to protect against mechanical shock.

Additional Information

The TitaniumCannulatedNailEXSystem is a Class IIb medical device under the EU Medical Device Regulation (MDR 2017/745) and is 510(k) cleared by the U.S. Food and Drug Administration (FDA) under product code HWC, regulation number 21 CFR 888.3020. The device complies with ISO 13485:2016 for quality management systems and ISO 14630:2012 for non-active surgical implants. The titanium alloy (Ti-6Al-4V ELI) used in the device meets ASTM F136 and ASTM F1295 specifications, ensuring biocompatibility, corrosion resistance, and mechanical strength. The device is intended for the stabilization of diaphyseal and metaphyseal femoral fractures, including transverse, oblique, spiral, and comminuted fractures, as well as pathological fractures. The 12° distal bend of the nail accommodates the natural femoral anteversion, reducing the risk of malrotation and improving load-sharing capacity. The cannulated design allows for minimally invasive insertion, preserving soft tissue integrity and reducing intraoperative blood loss. The system supports both static and dynamic locking configurations, enabling load-sharing and controlled bone healing. The device is compatible with standard orthopedic imaging systems, including C-arm fluoroscopy and portable X-ray machines, for real-time guidance. The seller provides comprehensive documentation, including the device’s Declaration of Conformity (DoC), CE Certificate, and FDA 510(k) clearance letter. The device has been used in clinical settings with a documented success rate of 94% for fracture union within 6 months, as reported in peer-reviewed orthopedic literature. The seller offers optional on-site training and installation support for healthcare facilities to ensure proper device handling and clinical integration. The device is not indicated for use in patients with active infections, severe osteoporosis, or metal allergies.