PARCUS MEDICAL PEEK CF Instrucciones De Uso página 3

The Parcus Knotless PEEK CF Push-In Suture Anchors are manufactured from PEEK CF (Polyetheretherketone carbon fiber
reinforced). These devices are MR Safe.
7. Sterilization
The Parcus Knotless PEEK CF Push-In Suture Anchors are supplied in sterile packaging. The contents are sterilized by EO
gas. These products must never be re-sterilized.
8. Storage
Products must be stored in the original unopened package in a dry place and must not be used beyond the expiration date
indicated on the package.
9. Directions for Use
A. Identify bone of sufficient quantity and quality into which the anchor is to be placed.
B. The Parcus Knotless PEEK CF Push-In Suture Anchor is inserted into a socket created with a Parcus Drill Bit. Reference
the box label of the Knotless Anchor for recommended drill/awl sizes. It should be noted that while two drill/awl sizes are
indicated, the smaller of the two is intended for use in less dense bone while the larger is for average to more dense bone.
Arthroscopic cannulae are typically used in conjunction with these devices. Always try to approach the targeted site as close
to perpendicular as possible. If using the Drill Guide, use the obturator supplied with the Drill Guide to aid in its passage
through tissue.
C. Place sutures (not supplied with anchor) through the targeted tissue. These sutures will be placed through the eye in the tip
of the anchor and will be secured when the anchor is driven into the prepared socket. The 2.8mm and 3.5mm Knotless
PEEK CF Push-In Suture Anchor will accommodate up to four (4) strands of #2 USP suture, the 4.5mm and 5.5mm Knotless
PEEK CF Push-in Suture Anchor will accommodate up to six (6). In arthroscopic applications, draw the sutures up through
the same cannula through which the Drill Guide will be used.
D. Insert the Drill Bit into a drill chuck or pin driver to a depth that covers the laser etched line on the proximal end of the Drill
Bit, as applicable. When using the Drill Guide, place the distal tip of the guide on the targeted bone and insert the Drill Bit
through its lumen. Advance the Drill Bit into the bone approximately 16mm or until the circumferential laser mark on the
distal tip of the Drill Bit is flush with the surface of the bone. Remove the Drill Bit and Drill Guide, carefully noting the
location of the prepared socket or leave the Drill Guide and Drill Bit in position until ready to insert the anchor.
E. Aseptically open the package containing the Knotless PEEK CF Push-In Suture Anchor. The anchor comes packaged with
a suture passer to aid in placing sutures through the distal eyelet. Parcus Knotless PEEK CF Suture Anchors are used with
a Parcus Driver which is either provided with the implant or separately. Drivers provided separately are available either as
sterile, single use devices or non-sterile and reusable. Assemble the suture anchor to the driver by inserting the tip of the
driver into the socket of the anchor and pushing until the driver is firmly attached to the anchor.
F. Pass the sutures placed through the tissue described in Step C, through the eyelet in the distal tip of the suture anchor. Use
the suture passer to aid in placing the suture through the distal tip of the anchor. If the Drill Bit was left in position as
described in Step D, remove it before proceeding.
G. Push the tip of the suture anchor into the prepared socket and using a suitable mallet, gently strike the driver handle,
advancing the suture anchor into the prepared socket, until the circumferential laser mark on the distal end of the driver is
flush with the bone.
Warning: Insertion of the anchor off axis from the hole may result in implant failure. Failure to insert the driver to
the depth indicated by the laser mark may result in the anchor being left proud.
H. Once implant is fully inserted, remove driver by pulling firmly and twisting slightly until the driver is free from the anchor.
I. Cut the ends of the remaining tails of the suture.