IFU-102 rev C
Flow-Screw TM
Cannulated Screw System
Instructions for Use
DESCRIPTION
The Flow-FX Flow-Screw is designed as a Cannulated Screw system for the fixation of a variety of fractures and is composed of a cortical screw and accompanying instruments. The Flow-Screw can also be used for the delivery of injectable bone void fillers capable of being delivered via a 16-gauge needle. The Flow-Screw is not designed to be coupled to other metal implants.
INDICATIONS
The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site to treat fractures throughout the skeletal anatomy as deemed appropriate by the surgeon.
MATERIALS
The Flow-Screw implant components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or stainless steel conforming to ASTM F138 or ASTM F2229.
CONTRAINDICATIONS
•	Insufficient quantity or quality of bone, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply.
•	Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
•	Any active or suspected latent infection or marked local inflammation in or about the affected area.
•	Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
•	Material sensitivity documented or suspected.
•	Patients having inadequate tissue coverage over the operative site.
•	Implant utilization that would interfere with anatomical structures or physiological performance.
•	Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
•	Use of contrast media in patients with a known contraindication to contrast.
•	Other medical or surgical conditions which would preclude the potential benefit of surgery.
•	Spinal fracture fixation.
•	Use with Polymethyl methacrylate (PMMA). 

WARNINGS
•	For professional use only.
•	Do not use this system without fully reading the instructions for use.
•	The surgeon should be familiar with the general principles and technique of treating fractures using cannulated screws.
•	The surgeon should be familiar with the general principles and technique of delivering bone void filler using the Flow-Screw system. The bone void filler must be used within the timeframe designated in its labeling.
•	Surgeons should follow the surgical technique.
•	Selection of the correct screw diameter and length is very important. Determination of the alignment of the fractured bones should be done using fluoroscopy and/or designated gauges.
•	If delivery of a bone void filler is required in an area adjacent to a joint, injection of 4cc of radiopaque contrast through the side port cannula is recommended to confirm the integrity of the articular surface. If the articular surface is not intact, delivery of bone void filler in that area is not recommended.
•	Patients should be cautioned against significant load bearing prior to good callus formation. Patients who are either noncompliant or predisposed to delayed union or non-union, must have auxiliary support.
•	Periodic x-rays are recommended for at least six months to detect any changes in position, nonunion, loosening, bending or cracking of components.
•	Patients should be cautioned that even after complete healing there is a higher risk for re-fractures while the screw is in position.
•	Postoperative care and physical therapy should be structured to prevent excessive loading of the operated extremity.
•	The implant system has not been evaluated for safety and compatibility in the MR environment, nor has it been tested for heating or migration in the MR environment.
•	Most parts, excepting specially packaged disposable kits, are delivered non-sterile. These must be sterilized prior to surgery in accordance with the Sterilization Section.
•	Flow-Screw is not indicated for fixation or attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
•	Flow-Screw implants should only be used for delivery of bone void fillers that have been validated for use with the device.

PRECAUTIONS / INSPECTION
•	The Flow-Screw implants, the guide-wire and the Side Port Cannula for the application of bone void filler are one-time use. The Side Port Cannula and Guidewire will be disposed of in accordance with local requirements. The implants are intended to remain in the patient.
•	The Flow-Screw Instrument set, with exception of the Side Port Cannula and Trocar-Tipped Guide-Wire, is intended to be reusable and will be cleaned and sterilized in accordance with the Sterilization Section.
•	The Side Port Cannula has been demonstrated to survive 5 steam sterilization cycles but should be examined for structural integrity before use.
•	Proper handling and storage of the system components is mandatory. Damage or alterations may produce stresses and cause defects, which could become the focal point for failure.
•	All implants and instruments must be inspected prior to use for any damage. Do not use if damage exceeds normal standards for implants and instruments.
ADVERSE EFFECTS
The adverse events include but are not limited to:
•	Implants may migrate, cause pain or stress shield bone even after a fracture has healed.
•	Pain, discomfort, nerve or soft tissue damage etc.
•	Metal sensitivity or allergies.
•	Trauma.
•	A pulmonary embolism may result from using this implant with an injectable bone void filler.
STERILITY
The Side Port Cannula, the Trocar-Tipped Guide-Wires, and intraosseous adapters are single use instruments and should be discarded after each use.
Cleaning
Scope
These cleaning instructions apply to the orthopedic surgical implants and instruments used to prepare the bone and implant the Flow-Screw Cannulated Screw implant set. The Side Port Cannula, the Trocar-Tipped Guide-Wires, and the intraosseous adapters are single use instruments and should be discarded after each use.
Both the Implants and the Instruments are contained in the same case/tray. The Implants are further contained within the case in a screw caddy. The intent is to clean the implants within their caddy separately from the instruments. Implant cleaning may be automated. Instruments are recommended to be cleaned manually. 

Warnings and Limitations
Automated cleaning may not be effective. A thorough, manual cleaning process is recommended.
Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must not be used. Enzymatic and cleaning agents with neutral pH are recommended.
Repeated processing, according to these instructions, has minimal effect on Flow-Screw reusable manual instruments. End of life is normally determined by wear and damage due to use.
Instructions at Point of Use
Separate any nested instruments and disassemble any instruments that can be disassembled without using tools. There are no instruments that will require disassembly using tools. Please refer to the surgical tray graphics for the expected state of disassembly.
Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with a damp cloth or submerge in a basin of sterile water. Body fluids and tissue should not be allowed to dry on instruments prior to cleaning.
Containment / Transportation
Universal precautions for handling contaminated/bio-hazardous materials should be observed.
Instruments and implants should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning.
Manual Cleaning Procedure
1.	Prepare neutral pH enzyme and cleaning agents at the use-dilution and temperature recommended by the manufacturer.
2.	Completely submerge the instrument in enzyme solution and allow it to soak for 20 minutes. Use a soft-bristled brush to gently clean the device (paying close attention to all threads, crevices and other hard-to-clean areas) until all visible soil has been removed. Any instruments with lumens or cannulas should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush). The enzyme solution should be changed when it becomes grossly contaminated.
3.	Remove the device from the enzyme solution and rinse in purified water (from one or any combination of the following processes: ultra-filter, RO, DI and/or distilled) for a minimum of 3 minutes. Thoroughly flush lumens, holes and other difficult to reach areas.
4.	Prepare the neutral pH cleaning (detergent) solution and place in a sonication unit.
5.	Completely submerge device in cleaning solution and sonicate for 10 minutes, preferably at 45-50 kHz.
6.	Rinse instrument in purified water (from one or any combination of the following processes: ultra-filter, RO, DI and/or distilled) thoroughly for at least 3 minutes
or until there is no sign of blood or soil in the rinse stream.
7.	Repeat steps 5 and 6 with freshly prepared cleaning solution until the instruments are thoroughly clean.
8.	Dry instrument with a clean, disposable, absorbent, non-shedding wipe.
Automated Cleaning Procedure
Automated washer/disinfector systems are not recommended as the sole cleaning method for complex surgical instruments. These instruments should be cleaned following the manual cleaning procedure above. An automated system may be used as a follow-up method but is not required.
Automated washer/disinfector systems are recommended for cleaning the Flow-Screw implants within their screw caddy. For effective automated cleaning of the screw caddy, remove the tray cover, remove the removable screw caddies.
Disinfection
Disinfection is only acceptable as an adjunct to full sterilization for reusable surgical instruments. See sterilization section below.
Inspection / Function Testing
1.	Carefully inspect each instrument and implant to ensure that there is no visible contamination and that all visible blood and soil has been removed. If visible contamination is evident, repeat the Manual Cleaning Procedure above.
2.	Visually inspect for damage and/or wear, corrosion, pitting, discoloration or separation of parts. If there is any evidence of damage, do not use the instrument or implant.
3.	Check the action of moving parts (such as hinges and box-locks) to ensure smooth operation throughout the intended range of motion.
4.	Check instruments with long slender features (particularly rotating instruments) for distortion.
5.	When instruments form part of a larger assembly, check that the devices assemble readily with mating components.
Inspection / Function Testing Failure
If an instrument fails inspection or a functional test due to improper cleaning, repeat the cleaning procedure. If the instrument continues to fail after repeated cleanings, discard the instrument.
If an instrument fails inspection or a functional test due to wear or damage, discard the instrument.
Maintenance
Lubricate hinges, threads and other moving parts with a commercial water-based surgical grade instrument lubricant (such as instrument milk) to reduce friction and wear.
Packaging
1.	Individually – a standard polyethylene/Tyvek (or equivalent) sterilization pouch of the appropriate size may be used for single instruments. Ensure that the pack is large enough to contain the instrument without stressing the seals or tearing the packaging.
2.	In Sets - sets of instruments may be loaded into dedicated instrument trays or general purpose sterilization trays for sterilization. If applicable, use standard medical grade steam sterilization wrap following the AAMI wrap method (ANSI/ AAMI ST79-2010).
Sterilization
Scope
Both the implants within their caddies and the instruments are intended to be sterilized together in their case/tray.
The following steam sterilization method should be performed:
PROCEDURE	FRACTIONATED VACUUM PROCEDURE	
Exposure Time	4 minutes	
Temperature	132°C	
Drying Time	30 minutes	

STORAGE INSTRUCTIONS
1.	Implants and instruments should be stored at room temperature.
2.	Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature and humidity extremes.
3.	Sterile instrument packages should be examined closely prior to opening to ensure that there has been no loss of package integrity.

These instructions have been validated by Flow-FX, LLC as being capable of preparing manual orthopaedic surgical instruments for re-use. It is the responsibility of the reprocessor to ensure that reprocessing is performed using the appropriate equipment and materials, and those personnel in the reprocessing facility have been adequately trained in order to achieve the desired result. Any deviation by the reprocessor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences.

                  CAUTION
Federal law restricts this device to sale by or on order of a physician. 
MANUFACTURER:
Flow-FX, LLC
9301 W. 191st St.
Mokena, Il 60448
Phone: (815) 531-4424
www.flow-fx.net