Fassier-Duval Telscopic Im System

• • Ongoing Z-2941-2024 FDA Class II ·initiated 4 Jul 2024 ·on shared 510(k) K041393

  During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

• • Terminated Z-1546-2015 FDA Class II ·initiated 10 Apr 2015

  The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.

• • Terminated Z-1472-2014 FDA Class II ·initiated 5 Mar 2014

  The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.

• • Terminated Z-1448-2014 FDA Class II ·initiated 7 Feb 2014

  The Male Components in this lot are made of material with lower strength than manufacturing specifications.

• • Terminated Z-1494-2011 FDA Unclassified (pre-2012) ·initiated 29 Jan 2010

  Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K041393 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Pega Medical, Inc. →

• What is the Fassier-Duval Telescopic IM System used for?

  The Fassier-Duval Telescopic Intramedullary System is designed specifically for internal fixation of long bone fractures in pediatric patients. Its telescoping mechanism accommodates natural bone growth, making it ideal for conditions like Osteogenesis Imperfecta or skeletal dysplasia where deformities or fractures may recur as the child grows. The system stabilizes the bone while allowing controlled extension, reducing the risk of further injury during development.

• How is the Fassier-Duval Telescopic IM System supplied and prepared for use?

  The system is supplied sterile and intended for single-use only in orthopedic surgical settings. This ensures sterility and safety for the patient. Prior to use, the device must be handled according to sterile instrument protocols to maintain its integrity. The telescoping mechanism requires precise surgical placement, so adherence to orthopedic surgical protocols is critical for optimal performance.

• Is the Fassier-Duval Telescopic IM System reusable or single-use?

  The Fassier-Duval Telescopic IM System is explicitly designed for single-use only. This is a standard practice for orthopedic implants to minimize infection risks and ensure patient safety. The sterile packaging and single-use designation align with FDA guidelines for intramedullary fixation devices, reinforcing its intended use in controlled surgical environments.

• What components make up the Fassier-Duval Telescopic IM System?

  The system consists of two primary components: a proximal female component and a distal male component. These components interlock via screw fixation, enabling the telescoping action that accommodates bone elongation. The design ensures stability while allowing gradual extension as the bone grows, which is particularly beneficial for pediatric patients with conditions requiring controlled bone remodeling.

• How should the Fassier-Duval Telescopic IM System be stored before use?

  The device must be stored in accordance with sterile instrument protocols to preserve its integrity. This includes maintaining the sterile packaging until immediately before use and adhering to manufacturer guidelines for environmental conditions (e.g., temperature, humidity). Proper storage ensures the device remains uncontaminated and ready for precise surgical placement, which is essential for its telescoping mechanism to function correctly.