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ENGLISH/INSTRUCTIONS FOR USE
Linvatec SE™ Graft Tensioning System DESCRIPTION The SE (Stress Equalization) Graft Tensioning System includes the non-sterile Graft Tensioner body, 6 mm Drill Guide, 8 mm Drill Guide, one (1) Suture Separator and two (2) sterile, single-use disposable Breakaway Pins with Graft Tension Calculator.
INTENDED USE The SE Graft Tensioning System is a modular system used during ACL reconstructive surgeries to apply independently variable tensile loads to each bundle of a soft tissue ACL graft during tibial fixation in order to distribute stress equally amongst the strands.
PRECAUTIONS 1. Inspect instruments before and after processing for proper function and alignment and for chipping of plated surfaces. 2. The SE Graft Tensioner is accurate to within ±15% of the load. However, the measurement accuracy may vary based on user technique. 3. The total combined load applied to grafts used in conjunction with the SE Graft Tensioner should not exceed 135 Newtons (30 pounds). 4. Do not use a powered handpiece to tension the graft bundles, as this may potentially over-tension the graft. 5. As with any sharp, use extreme caution while handling the Breakaway Pins. 6. Do not use the C8715 BioScrew® Universal Tri-Lobe Driver (fixed handle). It is too short to be used in conjunction with the SE Graft Tensioning System.
KEY TO FIGURES 1, 2 and 3 1. Drill Guide in place with Breakaway Pin being drilled. 2. SE Graft Tensioner with Suture Separator in place and sutures tied. 3. SE Graft Tensioner with Bioscrew® XtraLok® Interference Screw being inserted.
INSTRUCTIONS FOR USE 1. The semitendinosus and gracilis tendons are harvested. Each end of the graft is whip stitched. Note: Be sure to attach sufficient length of suture to each graft bundle for tying around pulleys. 2. Using the Linvatec Graft Sizing Block, the diameter of the individual grafts is measured in addition to the entire graft construct. 3. The femoral and tibial tunnels are created using standard instrumentation. 4. Using the largest size Drill Guide that the tunnel will accommodate, the cannulated Drill Guide is placed in the tibial tunnel. Be sure to spread the soft tissue and fascia around the outer pin guides of the Drill Guide (Figure 1). Note: Manually hold the Drill Guide assembly in position through steps 5 and 6. 5. One Breakaway Pin is drilled through each pin guide until the hard stop on the pin contacts bone. 6. The Breakaway Pins should then be broken off at the notch nearest to the Drill Guide aperture by gripping the Breakaway Pins near the aperture and bending them until the breakage point is reached. The Drill Guide is then removed, leaving the Breakaway Pins in place. 7. The graft construct is drawn into the knee and fixed in the femur by a method of choice. Note: The semitendinosus and gracilis grafts are identified by marking or knotting each of the semitendinosus and gracilis suture strands. 8. The Suture Separator is placed on the pin guides of the SE Graft Tensioner with spacers oriented towards the SE Graft Tensioner. 9. The pin guides are then placed over the Breakaway Pins and the suture limb from the semitendinosus graft is individually guided through the two retaining grooves on one side of the Suture Separator and tied securely around the pulley on that side. Similarly, the suture limbs from the gracilis are individually guided through the two grooves on the other side and tied around the pulley on that side. The split pulley design incorporates a pair of springs to compress the pulley halves. This acts as a locking mechanism to securely hold the suture on the pulley when the knot is tied behind the pulley. Ensure the knot is tight enough to slip into the split. Note: Be sure to take slack out of suture/graft construct and fully advance the slides when tying the individual graft bundles around the pulleys. The completion of this step secures the SE Graft Tensioner in place (Figure 2).
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10.Refer to the Graft Tension Calculator provided to determine the final tension for the semitendinosus and gracilis grafts. Graft Tension Calculator instructions are as follows: a. Determine the overall graft tension desired (i.e., 10, 15, 20 lbs. / 45, 70, 90 Newtons). b. Using the Graft Tension Calculator, locate the individual graft bundle diameters previously determined in step 2. c. Sliding the Calculator card, determine the position where the sum of the individual graft bundle forces equals the desired overall tension. d. The individual tension for each graft bundle (semitendinosus and gracilis) as determined by the Graft Tension Calculator, is then applied. 11. With the knee placed in the proper degree of flexion, such that the femoral and tibial tunnels are aligned, the semitendinosus and the gracilis grafts are individually tensioned using a Linvatec hex driver (8608, D8626, D8627) first to a conditioning force, which is higher than the final tension. 12.With a conditioning force placed on each graft bundle (semitendinosus and gracilis) the knee is cycled from full extension to deep flexion until the applied tension reaches a stable mean value. The length scale (mm) may be used to observe the excursion of each graft bundle during cycling as a measure of graft isometry. 13.Reset the Graft Tensioner to final set (force) value as determined by the Tension Calculator. 14.The Graft Tensioner may be used as a guide to align the BioScrew XtraLok or other interference screw axially within the tibial tunnel as it progresses centrally between the graft strands until the screw is fully seated (Figure 3). 15.While holding the Graft Tensioner in place the sutures are cut. The Graft Tensioner is then removed from the tibia. 16.The single-use disposable Breakaway Pins are removed and disposed of properly. Do Not Re-sterilize. Single Use Only. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent reuse may adversely affect the performance, safety and/or sterility of the device.
CLEANING 1. Follow universal precautions for protective apparel when handling and cleaning contaminated equipment. 2. Instruments may be cleaned manually as follows: a. Wash each component with a neutral pH cleaning solution and a clean, non-abrasive brush. b. Manipulate, rotate, and separate the pulley’s wheels while cleaning the Graft Tensioner body. Separate the pulleys and clean thoroughly between the pulley wheels. Caution: Particular attention should be placed on the compression springs on the outside of the pulleys during cleaning. c. Rinse each component under running water followed by another rinse with distilled or sterilized water. Caution: Saline solution is not recommended as it has a corrosive effect on certain metals. d. Dry all component surfaces using a clean, lint-free towel. 3. Instruments may be cleaned in an automatic washer/sanitizer as follows: a. Prepare all instruments to maximize exposure during the cleaning process. Rotate the Graft Tensioner knurled knobs to provide open access between the Slide Blocks and Pin Guides. Instruments must be placed at an approximate 45° angle between horizontal and any cannulations for effective cleaning and drainage. b. Wash, rinse, and dry the instruments with a neutral pH detergent cleaning cycle. Caution: Alkali detergent cycles are not recommended, even with acid neutralization, as they have a corrosive effect on certain metals.
STEAM STERILIZATION CAUTION: Do not drop sterilization tray or components. WARNING: The use of disinfecting solutions for an exterior instrument wipe will not sterilize the equipment and is not recommended. 1. Prepare all instruments so that all surfaces have direct contact with steam. Sterilization parameters for sterilizing instruments with or without the C9055 SE Graft Tensioning System Sterilization Tray. Pertains only to items with an asterisk (*) listed below under “Ordering Information” Method
Cycle
Minimum Temperature
Minimum Exposure
Dry Cycle
Steam (wrapped/unwrapped) Steam (wrapped/unwrapped)
Pre-vacuum Gravity
270°F (132°C) 270°F (132°C)
4 minutes 15 minutes
20 minutes minimum 20 minutes minimum
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NOTES: 1. Guidelines provided above do not guarantee sterility. Your institution is responsible for the normal sterility assurance validation. 2. Additional drying time may be required for complete heat and moisture dissipation. 3. Sterilization validation is based on AAMI guidelines (Association for the Advancement of Medical Instrumentation).
MAINTENANCE The SE Graft Tensioner contains moving parts that will wear, and a calibrated spring scale that may drift with continued use. The SE Graft Tensioner (C9050) should be returned to ConMed Linvatec for periodic maintenance and service after one year or 100 uses, whichever is shorter.
INFORMATION For more information or a product demonstration, contact your local ConMed Linvatec sales representative, or call 1-866-426-6633 in the U.S.
ORDERING INFORMATION REF
Description
C9050*
SE Graft Tensioner
Non-Sterile
C9051*
SE Graft Tensioner Drill Guide, 6mm
Non-Sterile
C9052*
SE Graft Tensioner Drill Guide, 8mm
Non-Sterile
C9053*
SE Graft Tensioner Suture Separator
Non-Sterile
C9054
SE Graft Tensioner Breakaway Pins with Graft Tension Calculator
Single-Use Sterile
C9055
SE Graft Tensioner System Sterilization Tray
Non-Sterile
PS8832
Grafix® Graft Sizing Block
Non-Sterile
C8716*
BioScrew Universal Driver (Modular)
Non-Sterile
D8640*
Ratcheting Handle (Modular System)
Non-Sterile
D8626
Modular Drive System, Grafix, Hex, Straight, 3.5 mm
Non-Sterile
D8627
Modular Drive System, Grafix, Hex Thin Shaft, 3.5 mm
Non-Sterile
8608
Driver, Hex (3.5 mm) Cannulated, Paramax
Non-Sterile
®
* Indicates items to be sterilized in the C9055 Sterilization Tray.
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MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany
UKRP CONMED UK Ltd 73/74 Shrivenham Hundred Business Park Swindon SN6 8TY United Kingdom
ConMed Corporation 525 French Road Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1 (727) 397-4540 email: [email protected] www.conmed.com ©2022 ConMed Corporation. All rights reserved. P000017748
Rev B
06/2022