Trephine RAL for Bone Grafting - JOTA (229RF.RAL.040) - Delynov

What is the RAL JOTA trephine (229RF.RAL.040)?

The RAL JOTA trephine, bearing the reference 229RF.RAL.040, is a specialized rotary instrument distributed by the brand JOTA. This device is designed for bone surgery, specifically for harvesting bone cores. Manufactured from metallic or plastic materials depending on the components, this instrument is delivered non-sterile. It requires a complete cleaning, disinfection, and sterilization protocol before its first use and after each subsequent use. As a graft trepan drill, it is essential for practitioners performing autogenous grafts. Its design allows for a clean cut of the bone to obtain usable bone cylinders in various reconstruction procedures.

What are the clinical indications for this bone graft trephine?

This bone graft trephine is indicated for oral and implant surgery procedures requiring precise bone harvesting. It is primarily used as a bone harvesting trephine to extract autogenous bone cores, often considered the "gold standard" in reconstruction. Practitioners also use it to prepare implant sites or to remove bone fragments during corrective surgeries. The manufacturer JOTA AG specifies that these instruments are reusable, subject to the practitioner's assessment of wear. The intended use includes all clinical situations where a circular osteotomy is necessary to collect bone or to clear a specific site with a surgical trepan drill.

What are the technical characteristics of this instrument?

The RAL trephine from the brand JOTA (reference 229RF.RAL.040) is a precision rotary instrument. It is compatible with ultrasonic cleaning agents, provided they do not form foam. The manufacturer emphasizes the importance of checking the compatibility of detergents with the instrument materials, particularly respecting the recommended concentrations, temperatures, and soaking times. To ensure optimal performance, rinsing must be carried out with sterile demineralized or low-contamination water. This graft trepan drill must be inspected before each cycle to detect any signs of wear or potential breakage, as the manufacturer cannot guarantee the performance of worn products.

What are the contraindications for the use of this device?

Although the source text does not list specific medical contraindications related to systemic pathologies, it imposes strict restrictions related to the condition of the instrument. Use is contraindicated if the labeling contains specific contradictory information or if the instrument shows signs of wear or breakage. The physician or expert using the JOTA brand device is solely responsible for the decision to reuse the product or not. In case of doubt regarding the structural integrity of the bone graft trephine bur, it is formally recommended to dispose of the product prematurely and replace it to avoid any risk during the surgical act.

What are the maintenance and reuse precautions?

The JOTA AG trephine is a reusable device that requires a rigorous reprocessing protocol. Before the first use, the removal of the protective packaging must be followed by cleaning, disinfection, and sterilization after packaging. The practitioner must ensure that the procedures used are specifically validated for this type of device and that the equipment (sterilizers) is checked regularly. The frequency of reuse depends exclusively on the surgeon's expertise regarding the observed wear. To maintain safety, it is imperative to use fresh solutions and water with low endotoxin contamination when cleaning this surgical trepan drill.

Who is the manufacturer and what standards are met?

The official manufacturer of this instrument is JOTA AG, located in Rüthi, Switzerland. This medical device belongs to Class IIa and bears the CE0483 marking, guaranteeing its compliance with European regulatory requirements for medical devices. The brand JOTA ensures the distribution of these high-precision instruments. All reprocessing instructions provided by JOTA AG apply to the entire range, except for specific exceptions. Compliance with these standards and the validated parameters during each sterilization cycle is the responsibility of the healthcare professional, thus ensuring the safety and performance of the trephine during bone grafting procedures.

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