Mayo-Hegar Needle Holder by RWD
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Origin Category | Domestic (China) |
| Models | F31034-15, F31034-18 |
| Pricing | Upon Request |
Overview
The Mayo-Hegar Needle Holder by RWD is a precision surgical instrument engineered for secure needle manipulation during suturing procedures in general surgery, gynecology, urology, and veterinary applications. Designed in strict accordance with classical Mayo-Hegar geometry, this instrument features interlocking ratchet teeth and a robust box-lock joint that ensures consistent clamping force retention throughout extended use. Its ergonomic handle design—optimized for both thumb-index grip and palm-held control—minimizes hand fatigue during repetitive suture placement. Constructed from high-grade, corrosion-resistant stainless steel (AISI 420 or equivalent), the instrument undergoes rigorous passivation, electropolishing, and vacuum heat treatment to meet ISO 7153-1:2016 requirements for surgical instruments. The tip geometry is precisely ground to provide optimal needle engagement without slippage or deformation of suture needles—critical for maintaining suture integrity in delicate tissue approximation.
Key Features
- Two standard lengths available: 150 mm (F31034-15) and 180 mm (F31034-18), enabling selection based on procedural access requirements and surgeon preference.
- Box-lock mechanism with six-position ratchet provides incremental, repeatable locking force—designed to prevent unintended release under tension while allowing rapid disengagement when required.
- Tip surface finish meets Ra ≤ 0.4 µm specification per ISO 13485:2016 Annex A, ensuring smooth needle contact and minimizing micro-abrasion of suture material.
- Autoclavable up to 134 °C (273 °F) for ≥1000 cycles; compatible with all standard sterilization methods including steam, ethylene oxide (EtO), and low-temperature hydrogen peroxide plasma.
- Manufactured under an ISO 13485:2016-certified quality management system; each batch undergoes dimensional inspection, hardness verification (52–56 HRC), and functional load testing (≥35 N tip closure force).
Sample Compatibility & Compliance
The Mayo-Hegar Needle Holder is validated for use with all standard suture needles—including reverse-cutting, taper, and blunt-point configurations—across diameters from 15 to 35 gauge. It accommodates both stainless steel and absorbable synthetic needles (e.g., polyglycolic acid, polylactic acid) without compromising needle geometry or suture thread integrity. The device complies with ISO 7153-1:2016 (Surgical Instruments – Metallic Materials – Part 1: Stainless Steels), ISO 13485:2016, and EU MDR 2017/745 Class I (non-sterile, reusable). Documentation includes full traceability records, biocompatibility assessment per ISO 10993-1 (cytotoxicity, sensitization, irritation), and sterilization validation summaries.
Software & Data Management
As a manually operated, non-electronic surgical instrument, the Mayo-Hegar Needle Holder does not incorporate embedded software or digital interfaces. However, its design supports integration into digitally managed perioperative workflows: instrument identification is enabled via laser-etched alphanumeric codes (model, lot number, and manufacturing date) compliant with UDI (Unique Device Identification) requirements under FDA 21 CFR Part 830 and EU MDR Annex VI. These identifiers facilitate inventory tracking, reprocessing log linkage, and audit-ready documentation within hospital asset management systems (e.g., RFID-enabled trays or barcode-scanned sterilization logs). All manufacturing and QC data are retained for ≥10 years per ISO 13485:2016 clause 8.2.5.
Applications
This instrument is routinely employed in open surgical procedures requiring precise needle control—including abdominal wall closure, fascial approximation, vascular anastomosis, and tendon repair. Its balanced weight distribution and tactile feedback support fine motor control in confined anatomical fields. In veterinary practice, it is widely used for orthopedic fixation and soft-tissue reconstruction across canine, feline, and equine species. The 15 cm variant is preferred for superficial or pediatric cases; the 18 cm version offers enhanced reach and leverage for deeper cavities or larger anatomical structures.
FAQ
Is the Mayo-Hegar Needle Holder supplied sterile?
No—it is provided non-sterile and intended for terminal sterilization by the end user prior to first use.
What maintenance is required between uses?
After each procedure, rinse immediately with warm water and enzymatic detergent; inspect ratchet and jaw surfaces for debris or wear; lubricate pivot point with medical-grade instrument oil before autoclaving.
Can it be used with powered suture drivers or robotic platforms?
It is designed exclusively for manual operation and is not compatible with robotic or motorized suture delivery systems.
Does RWD provide instrument tracking or reprocessing validation support?
Yes—customized reprocessing validation protocols and UDI-compliant labeling services are available upon request for institutional procurement contracts.
What is the recommended replacement interval?
Replace when ratchet engagement becomes inconsistent, jaw alignment deviates beyond ±0.1 mm, or surface pitting exceeds ISO 7153-1 visual acceptance criteria—typically after 500–800 sterilization cycles under proper handling conditions.
