DE – Gebrauchsanweisung ………….. 2
EN – Instructions for use ………………. 8
ES – Instrucciones de uso ………….. 14
FR – Guide d’utilisation ………………. 20
IT – Istruzioni per l’uso ……………… 26
PT – Instruções de utilização ………. 32
DEVICE DESCRIPTION: The InFrameâ„¢ Intramedullary Threaded Micro Nail System Hand Implant includes bone screws and single-use instruments intended for use in minimally invasive repair or reconstruction of small bone fractures. The screws have a diameter of 2.0 mm and are available in lengths ranging from 12 mm – 48 mm. Sizing selection correlates to the length of the bone to be repaired.
InFrameâ„¢ screw implantation requires three accessory devices, provided in an instrument kit:
• Guidewires to prepare the medullary cavity,
• A depth gauge, and
• A custom cannulated driver.
INTENDED PURPOSE
The InFrameâ„¢ system is intended for intramedullary fixation of small bone fractures, such as fractures of the proximal and middle phalanges of the fingers. The instrument kit is designed to facilitate placement of the implant.
INDICATIONS
InFrameâ„¢ Intramedullary Threaded Micro Nail System Hand Implant is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; and osteotomies of the phalanges.
CLINICAL BENEFIT
The intended clinical benefit of InFrameâ„¢ is to provide fixation for patients with fractures as a result of trauma, osteotomy or reconstruction of bones of the appropriate size. The indirect clinical benefit of the encompassed instrumentation is to facilitate implantation protocols for fracture fixation.