Surgical screwdriver, single-use

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

公众评估报告 公众评估报告 (PAR)
22-01-2021

可用日期:

Medtools Pty Ltd

类:

Class I

厂商:

Medtools Pty Ltd 3a Cheyne Walk, Castlecrag, NSW, 2068 Australia

治疗领域:

47633 - Surgical screwdriver, single-use

疗效迹象:

Title: Hammer Head 5mm square offset wrench with 3 engagement points. GMDN 47633 Surgical screwdriver, single-use, non-sterile. Description: Robotics are becoming common place in Orthopaedic joint replacement surgery with the Stryker MAKO system being one of the leading technologies. As an example, this system requires navigation trackers to be attached to the patient?s operative limb. Currently these trackers are positioned by the surgeon and hand tightened with a screwdriver. The MAKO trackers have 5mm square nuts at each articulated joint. This square nut needs to be tightened with a significant torque to prevent loosening during the case, one that is not achieved easily or consistently with a screwdriver piece. Often access to the nut is made difficult because of the location on the patient?s limb and adjoining joints or abdomen interfering with the leverage arc. The Hammer Head overcomes these difficulties by having these defining features; Claims: Fig 1: Square profile measuring 5.1mm for accurate and easy engagement of the square nut. Fig 2: Secondary square profile measuring 5.1mm but at 45 degrees to Fig 2 resulting in more leverage arc positions for difficult and confined areas. Fig 3: Third square profile measuring 5.1mm located at the end of the handle piece which allows the user to rapidly tighten the nut finger tight before using Fig 1 or Fig 2 to finish off the tightening process. Fig 4: Offset wrench ? this enables easier access to the nut Fig 5: Solid medical grade 316 stainless steel construction or similar. Fig 6: The square corners are profiled into 4 * 1.5mm diameter circles to make tool engagement and release easier. It allows for forgiveness and prevents locking onto the nut by allowing blood, tissue and foreign debris to be pushed out from the main square profile into these voids. Fig 7: Optimal length and diameter to easily fit into Surgeon?s hand. Hammer head design allows user to grasp handle with index, middle, ring and little finger while using the thumb to press down on the offset cylinder Fig 4 ensuring even and consistent pressure while tightening or loosening the nut. This prevent slippage which would otherwise injure the patient or surgeon. Medtools PTY LTD 3a Cheyne Walk Castlecrag, NSW 2068 0448788524 yeuns@aol.com 28.10.2020

授权状态:

A

授权日期:

2020-11-02

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