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Doc. No.: LC-73-0004-014 Rev. A (Dec-18)
INSTRUCTIONS FOR USE
TriMed
®
Surgical Instruments
Caution: Federal Law restricts this device to sale by or on the order of a Physician.
General:
TriMed
®
Surgical Instruments are an array of generic and unique instruments designed specifically for
orthopedic surgery. Such tools facilitate orthopedic surgeons to achieve, enable or expedite specific tasks
related to surgical techniques and implant systems. TriMed Surgical Instruments are reusable or single-
use devices. Generally, single-use devices perform drilling, sawing, cutting, and boring occurring within
musculoskeletal structures. Reusable instruments
perform other functions occurring outside
musculoskeletal structures such as: fastening, bending, crimping, impacting, inserting/extracting/
retracting, grasping, repositioning, aligning/aiming, trial/templating, tensioning, torqueing, cutting,
clamping, elevating, and gauging.
Basic Design Features:
TriMed Surgical Instruments are manufactured from medical-grade stainless steel, titanium, aluminum,
nickel titanium and/or common medical device polymers. Instruments may be hand-held, manually
operated or attached to powered equipment, where applicable. TriMed Surgical Instruments should only
be used with the appropriate TriMed devices (i.e. interacting instruments and implants) per surgical
technique.
Indications, Contraindications, Adverse Effects:
TriMed Surgical Instruments shall only be used for their intended purpose. Surgical technique provides
method of application for principal instrumentation. The decision to use an instrument must be based on
sound medical judgement that takes into consideration factors such as surgical application, physical and
mechanical properties. Medical personnel are encouraged to contact their TriMed representative(s) if a
more comprehensive understanding of the instrument mechanics or its method of use is required.
Possible Adverse Effects:
In any surgical procedure, the potential for adverse reactions exist. Possible adverse effects particular to
surgical instruments are listed below. These do not include all adverse effects which can occur with surgical
procedures.
Compromised mechanical, physical or chemical characteristics resulting in,
a.
Patient related
i.
Bone damage or necrosis
ii.
Inflammatory, foreign body or allergic reaction
iii.
Infection
b.
Device related
i.
Loosening, decoupling, bending, stripping, cracking or fracturing of device
ii.
Breakage resulting in device fracture fragments within wound
iii.
Loss or lack of function or connecting mechanisms
The adverse effects listed here are not specific to the TriMed Surgical Instruments and are in principal
observed with any orthopedic or surgical instrument. Promptly inform the TriMed Quality Department
at [email protected] if complications occur in connection with the surgical instruments used.
In the event of premature failure of an instrument in which a causal relationship with its geometry,
surface quality or mechanical stability is suspected, please provide TriMed with the device in a
cleaned, disinfected condition per TriMed’s cleaning and sterilization instructions.
Warnings and Precautions:
All Instruments:
1. Refer to instrument label to determine whether an instrument is single use or reusable. Single use
instruments are labeled with a single-use only “do not reuse” symbol.
2. Surgeons are advised to review the product-specific surgical technique prior to performing
surgery. Surgeons should also be fully familiar with the instrument, the method of application, and
surgical technique. Proper handling and use of the device are critical considerations in successful
utilization of this device.
3. TriMed Surgical Instruments shall not be used for any purpose other than their intended use.
4. TriMed Surgical Instruments should only be used with the appropriate TriMed devices (i.e.
interacting instruments and implants). TriMed has not tested compatibility with devices provided by
other manufacturers and assumes no liability in such instances.
5. Both reusable and single use instruments are subject to wear with repeated use. Inspect
instruments prior to use to verify condition and do not use if damaged or worn.
6. Instrument breakage or damage can occur when an instrument is subjected to excessive or
inappropriate loads for the specific application, blunt force, excessive speeds, dense bone,
improper use, or unintended use.
Cutting, bending, or scratching the surface of metallic or polymer
components may impair the strength and life of the device.
7. TriMed Surgical Instruments (e.g. depth gauge stylus) should not be repeatedly bent at the same
location or bent to excessive angles as it may potentially lead to premature fatigue, loss of
accuracy/calibration or breakage
in situ
.
8. A full inventory of instruments and implants should be available prior to initiating a surgical
procedure. Components should be tested in trial assembly prior to the actual operation.
9. Use caution in the handling and storage of instruments. After sterilization, reusable instruments
should be stored in the sterilization wrapped rigid container in a dry and dust-free environment.
Instruments should be stored away from environments and agents that may cause contamination
and deterioration.
Single Use Instruments:
10. Single use instruments must not be reused and must be discarded after the completion of a
surgical procedure.
11. Reuse of single use instruments may pose health and/or safety risks to the patient and surgeon
that may include, and are not limited to cross-infection, breakage resulting in irretrievable
fragments, compromised mechanical performance due to wear, loss of function and effectiveness
of proper cleaning and sterilization.
12. Attention should be paid to instruments performing drilling, sawing, cutting and
boring functions (e.g. drill, saw blades, reamers). Inspect cutting feature prior to
use and do not use if damaged or worn which could adversely affect safety,
performance and/or compliance with relevant specification.
Reusable Instruments:
13. Reusable instruments have a limited lifespan. Considerations for reusability relate
to maintenance of device function and physical integrity. Generally, end of life is
determined by wear, damage and compromised performance due to use. Inspect
instruments for damage or malfunction prior to each use and at all stages of
handling.
14. Prior to and after each use, reusable instruments must be inspected where
applicable for sharpness, wear, damage, proper cleaning, corrosion and physical
integrity of mechanical functions. If instrument appears damaged, it should not be
used.
15. Attention should be paid to instruments that perform driving/fastening, clamping,
inserting/extracting/retracting and gauging functions (e.g. drivers, bone clamps, depth
gauges).
16. Some TriMed driver shafts must be connected to a hand-held, manually operated
handle, and are not advised to be placed under power equipment. Possible risks
using drivers under power include stripping, bending, cracking or fracturing of the
instrument and/or implant. For driver shafts where power equipment may be used,
the surgeon must carefully control of the speed and power of insertion. It is
inappropriate to use power equipment with smaller sizes of TriMed driver shafts and
some cannulated drivers. It is the responsibility of the surgeon to ensure safe use.
Recommendations for cleaning and sterilization:
TriMed products supplied in a non-sterile condition must be cleaned and steam sterilized
prior to surgical use. Prior to cleaning and/or sterilization, remove and dispose all original
disposable packaging (e.g. silicone sleeves, tip guards, pouches, bags, tubes, etc.)
Component devices must be disassembled prior to cleaning, disinfection and sterilization.
Cleaning:
TriMed recommends the following cleaning procedures for non-sterile, reusable
instruments. Due to variations in conditions and environments, the user has final
responsibility for the implementation and verification of procedures to achieve cleanliness.
1. Rinse the soiled device under lukewarm running tap water (22° - 43° C) for a
minimum of two (2) minutes. Remove gross soil using a soft-bristled brush or clean,
soft, lint-free cloth. Note: Remove additional soil from challenging design features
(i.e. holes lumens, hinged/mating surfaces, interfaces, crevices, serrations) using
common cleaning tools. Never use metal brushes or steel wool for cleaning.
2. Prepare an enzymatic cleaning solution using Steris
®
Prolystica
®
2X Concentrate
Enzymatic Presoak per the manufacturer’s instructions.
3. Fully immerse the instruments in the fresh, newly prepared enzymatic cleaning
solution and soak for twenty (20) to twenty-five (25) minutes.
4. Use a soft-bristled brush to gently clean the submerged device paying particular
attention to crevices, lumens, mated surfaces, and other hard-to-clean areas.
Brush for a minimum of 15 seconds or longer if needed to remove debris. Lumens
should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush)
if needed to remove debris. Note: The enzyme solution should be changed when it
becomes grossly contaminated (bloody and/or turbid).
5. Remove the instruments from the cleaning solution and rinse with lukewarm,
running tap water (22° – 43° C) for a minimum of one (1) minute. After rinsing
ensure debris is removed from the instrument. If debris remains, use a syringe to
flush the device or repeat rinsing until debris is removed.
6. Prepare an enzymatic cleaning solution Steris
®
Prolystica
®
2X Concentrate
Enzymatic Presoak according to the manufacturer’s instructions. Place all
instruments within a container with the enzymatic cleaning solution and place the
container in the sonication unit.
7. Fully immerse the device in the fresh, newly prepared enzymatic cleaning solution.
Actuate the joints, handles, and other movable device features to expose areas to
the cleaning solution several times. Sonicate for ten (10) to fifteen (15) minutes.
8. Fully immerse the device in a basin with clean lukewarm tap water (22° - 43° C) for
rinsing. Gently agitate the device for a minimum of one (1) minute. Actuate the
joints, handles, and other movable device features to expose areas to the water
several times. Pass a soft bristled brush through any crevices or lumens.
9. Repeat steps 7 and 8 with freshly prepared cleaning solution if there is a sign of
blood or soil in the tap water bath.
10. Remove the instruments from the rinse solution and rinse with lukewarm, running
tap water (22° – 43° C) for a minimum of one (1) minute. After rinsing ensure debris
is removed from the instrument. If debris remains, use a syringe to flush the device
or repeat rinsing until debris is removed.
11. Dry the device using a clean, soft, lint-free cloth or clean compressed air. Visually
inspect the device; no visible soil should be left on the device. Note: Thorough
drying of instruments prevents corrosion from mineral content, condensate and
residual agents.
Warning: Use of automated washer/dryer systems absence manual cleaning is not
recommended as the sole cleaning method for TriMed surgical instruments.