Instructions For Use

The Chopper- IFU

Device Description:

The Chopper is a pedicle screw removal tool using the helicopter technique to remove pedicle screws. The Chopper is manufactured from medical grade 304 stainless steel.

Indications for Use:

When used with a corresponding set screw driver (can be from a universal removal set or from the actual set as long as the drive type fits the set screw), The Chopper is designed to use counterclockwise torque force to reverse screw a pedicle screw. The original set screw from the initial construct should be removed, the existing rod then remove and the chopper crossbar inserted into the saddle of the pedicle screw tulip then the set screw tightened down through the tube of the chopper to make the pedicle screw fixed.

Potential Adverse Events:

• Fatigue fracture of the instrument

• Unintended haloing of the pedicle screw

• Pedicle Fracture

• Vertebral Body fracture

Warnings and Precautions:
- A successful result is not always achieved in every surgical case. This fact is especially true in
spinal surgery where other patient conditions may compromise the results.

- Preoperative and operating procedures, including knowledge of surgical techniques is a consideration in the successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly affect the results.

-Do not use the instrument if there is visible damage or anything that compromises the integrity of the instrument.
 

Materials:

The Chopper pedicle screw removal system is manufactured from medical grade 304 stainless steel.

Contraindications:

The Chopper pedicle screw removal system is contraindicated in the presence of stainless steel allergy.

-This device is not intended for use except as indicated.

 

 

 

 

 

Pre-Cleaning/Cleaning and Sterilization Procedure Recommended for Reusable

Instruments (and Trays):

For safety reasons, reusable instruments must be pre-cleaned, cleaned and sterilized before use.

Moreover, for good maintenance, reusable instruments must be pre-cleaned, cleaned and

sterilized immediately after surgery following the sequence of steps described in the following

table.

Cautions: Long, narrow cannulations and blind holes require particular attention during

cleaning.

Limitations on reprocessing: Repeated processing has minimal effect on these

instruments. End of life is determined by wear and damage due to use.

1-Point of use: Remove all visual soil with disposable cloth/paper wipe. Soiled

instruments must be kept moist to prevent soil from drying. If the instruments cannot be

soaked immediately place a moist towel around them until they can be cleaned.

2-Containment and transportation: Avoid damage and minimize time before cleaning

3-Preparation for cleaning: Dis-assemble instruments as required. For The Chopper System, the only instruments requiring disassembly would be separating the topper from the torque tube.

4 Thoroughly clean instruments per one of the following (Manual or Automated)

Manual Automated

4.1 Pre-Cleaning-Manual:

• Prepare a pH neutral, enzymatic

detergent soak per the instructions of

the enzymatic solution manufacturer.

• Soak the instrument for a minimum

of 15 minutes. Actuate any

mechanisms and slide moving parts

to the extreme positions to ensure the

cleaning solution contacts all the

4.1 Pre-Cleaning-Automated:

Automated washing shall be conducted in

a validated washer-disinfector.

An example of a validated cycle used for

cleaning validation includes:

• Wash 45⁰C 4 minutes dose pump

4 (detergent) 5mL

• Change the soak solution if the

solution becomes visibly soiled.

• While still in the soak solution, use a

soft brush to remove all exterior soil.

Thoroughly scrub any grooves, corners or cannulas. Use

an appropriate size cleaning brush to

thoroughly brush the entire length of

any internal lumens a minimum of

five times per lumen.

• Rinse instruments thoroughly warm

(approximately 35-40°C) critical

water, such as reverse osmosis,

distilled, and/or deionized water,

taking care to flush all lumens or

crevices, for at least one minute, until

water runs clear. Use a tubing

attachment to the water outlet in order

to direct the rinse flow into any

lumens, crevices, grooves, or slots

and flush them completely until water

runs clear

• Wash 60⁰C 3 minutes

• Rinse with unheated critical

water, such as reverse osmosis,

distilled, and/or deionized water

for 1 minute.

• Rinse 60⁰C 1 minute

4.2 Cleaning-Manual:

• Prepare a fresh pH neutral enzymatic

cleaning solution and sonicate the

instruments and subassemblies for a

minimum of 15 minutes in an

ultrasonic bath. After sonication,

rinse instruments again under running

critical water, such as reverse

osmosis, distilled, and/or deionized

water for a least one minute until

water runs clear. Use a tubing

attachment to the water outlet in order

to direct the rinse flow into any

lumens, crevices, grooves, or slots

and flush them completely until the

water runs clear.

• Dry the exterior of the instruments

with a clean, soft cloth. Use clean

compressed air or 70% isopropyl

alcohol to dry any lumens or crevices

where water may become trapped.

4.2 Washer Disinfector:

Automated washing shall be conducted in

a validated washer-disinfector.

An example of a validated cycle used for

cleaning validation includes:

• Thermal Disinfection A0 93⁰C

• A0 value: A03000

• Dry 123⁰C air 14 minutes

Inspection:

• Visually inspect each disassembled device to ensure all visible blood and soil has

Method Cycle Temperature Minimum Exposure

Time

Drying Times

Steam Gravity 270°F (132°C) 15 Minutes 15 Minutes

Steam Pre-Vacuum 270°F (132°C) 4 Minutes 30 Minutes

been removed. If not visually clean repeat step 4 above until clean or

appropriately dispose of device if unable to get visually clean.

• Check disassembled instruments with long slender features for distortion.

• Inspect the disassembled devices for any cracking, pitting, or other signs of

deterioration

Packaging: Wrap the instruments using

appropriate FDA cleared wrap.

Sterilization: See sterilization procedure

Storage: Control environment

Additional information: When sterilizing multiple instruments/trays in one autoclave

cycle, ensure that the sterilizer’s maximum load is not exceeded.

Manufacturer contact: Contact local representative or call customer service

Product Complaints: Any Healthcare Professional (e.g., customer or user of this system of

products), who has any complaints or who has experienced any dissatisfaction in the product

quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify

FieldCraft Ortho LLC 750 W Hampden Ave. Ste L-100, Englewood, CO 80110 (512)638-3658.

Further Information: A recommended surgical technique for the use of this system is available

upon request from FieldCraft Ortho LLC. 750 W Hampden Ave, Ste L-100, Englewood, CO 80110