Adverse Effects - Johnson & Johnson DePuy Synthes TRUESPAN Manual De Instrucciones

ADVERSE EFFECTS

Adverse effects of implanted polymer devices include
mild inflammatory response and foreign body reactions.
MR STATEMENT
The TRUESPAN Meniscal Repair Implant System is
MR Safe.
INSTRUCTIONS FOR USE
1. Open the TRUESPAN Meniscal Repair System
package using aseptic technique. Remove the
device from the package.
2. Using a calibrated probe, measure the width of the
meniscal tissue to be repaired. Set the adjustable
depth stop to minimize tissue penetration depth,
as desired. Depth stop is preset at 18 mm.
3. During needle insertion use a malleable graft
retractor or slotted cannula to prevent the needle
from catching on or damaging soft tissue (e.g. fat
pad and/or articular surface). Once inside the joint
space, remove the instrument.
4. Penetrate the tissue to desired depth, referencing
the laser line at 10 mm on the needle as a
secondary depth indicator as needed.
5. At desired depth, fully squeeze the red deployment
trigger while maintaining depth positioning to
deliver the first implant. The implant is fully
deployed when you hear an audible "click" . Fully
release the trigger after deployment.
6. While maintaining visibility of the tip of the needle
in the scope, carefully withdraw the needle from
the tissue to prevent unintended displacement of
the second implant.
7. Locate the intended position of the second implant,
which should be approximately 6 mm to 9 mm from
the first implant. Penetrate the tissue to desired
depth, again referencing the laser line at 10 mm
on the needle as a secondary depth indicator as
needed. Avoid damaging suture with needle.
8. At desired depth, squeeze the red deployment
trigger while maintaining depth positioning to
deliver the second implant. The implant is fully
deployed when you hear an audible "click" .
9. Release the deployment trigger and remove the
device from the joint space. The free suture tail
will release from the depth stop sheath when the
applier is removed from the joint space.
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