Cleaning And Sterilization - DePuy Synthes RIGIDLOOP Manuel D'utilisation

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• The trailing suture is a utility suture and is not intended for

implantation.

• After tensioning construct, do not trim the adjustable suture

tail to less than 6mm. As with any knot construct, short tails

may result in reduced post-operative knot security.

MR STATEMENT

Non-clinical testing has demonstrated that the titanium

implants are MR Conditional. A patient with a titanium implant

can be scanned safely under the following conditions:

• Static Magnetic Field of 1.5 or 3.0 Tesla.

• Spatial Gradient Field of 720 Gauss/cm or less.

• Maximum MR System reported, whole-body-averaged specific

absorption rate (SAR) of 4.0 W/kg for 15 minutes of scanning

(i.e., per pulse sequence) in the first level controlled mode.

Under the scan conditions defined above, the RIGIDLOOP

Adjustable Cortical Fixation System is expected to produce a

maximum temperature rise of 2.8°C or less after 15 minutes of

continuous heating.

Artifact information: The artifact of the RIGIDLOOP

Adjustable Cortical Fixation implant is expected to extend

about 1.5cm beyond the implant. Therefore, optimization of MR

imaging parameters to compensate for the presence of this

device may be necessary.

Recommendations:

• Consider the presence of other implants and consult labeling

for MR compatibility information.

• The effects of local RF transmit coils have not been tested

and are not recommended in the area of the implant.

• Prevent the patient's arms and legs from touching each other

or the side of the bore during scanning.

INSTRUCTIONS FOR USE

1. Ream 4.5mm passing tunnel and graft socket.

2. If graft socket breaches cortex, use Adjustable Cortical XL

Implant to complete reconstruction.

3. Pass implant construct through the bone tunnels using the

green-and-white-striped leading suture.

4. Flip the button on the cortex by pulling the green trailing

suture and/or the graft. Confirm deployment by toggling

leading and trailing sutures or by pulling on graft.

5. While maintaining counter tension on the graft, advance

graft into the socket by pulling the white adjustable suture

until the graft is fully seated.

6. Fixate opposing end of the graft.

7. Cut the white adjustable suture.

8. Cut the green-and-white-striped leading suture.

9. Remove the green trailing suture.