DynaClip® Bone Fixation System- Instructions for Use | MedShape DynaClip® Bone Fixation System- Instructions for | Page 7

• The patient should be encouraged to receive prompt medical attention
for infection that may occur at surgery site or elsewhere in the body.
11. PREOPERATIVE PLANNING INFORMATION
• Careful preoperative planning must be conducted.
• Never attempt a surgical procedure with defective, damaged
or otherwise compromised instruments or implants. Inspect all
components preoperatively to ensure that the device components and
instruments are appropriate for use.
• Handling of the DynaClip Bone Fixation System must be performed
in accordance with aseptic handling practices to maintain sterility
following sterilization by the manufacturer (Device).
12. GENERAL DIRECTIONS FOR USE
In a typical application, the surgical exposure for insertion of a staple is
similar to the insertion of bone screws or a screw and plate system. The
staple is generally located to span a fracture or osteotomy. The arms of
the staple, in its final state, are biased inwards providing compression
across the fracture, osteotomy or arthrodesis site. The site is reduced and
holes (one for each leg of the staple) are drilled through the near cortex,
and no further than beyond the opposite cortex using the guide and drill bit
matched to the cross section of the staple legs. The staple is inserted into
the resulting holes.
Operation
The implantation technique outlined below is intended to illustrate an
example procedure using the DynaClip Bone Fixation System. Depending
on the surgical anatomy, the fracture or osteotomy to be treated and the
surgeon, the procedure may include additional or fewer steps. Proper
selection of DynaClip implants is dependent upon the surgical anatomy,
the fracture or osteotomy to be treated and the surgeon.
1. Reduce or re-approximate fracture, osteotomy, or joint. Apply
temporary reduction and fixation.
2.
.
Apply the Universal Drill Guide to the repair site. Insert appropriate drill
bit into the Universal Drill Guide. Drill first hole to the depth of the
appropriate leg length of the implant. Calibration depth marks on the
drill bit can be used as an approximate measure of drill penetration to
match the length of the implant legs. Place appropriate Locator Pin in
the first drill hole.