DynaClip® Bone Fixation System- Instructions for Use | MedShape DynaClip® Bone Fixation System- Instructions for | Page 5

Patients with senility, mental illness, alcoholism, or drug abuse may be
at a higher risk of device failure. These patients may ignore instructions
and activity restrictions. The patient is to be instructed in the use of
external supports, walking aids, and braces that are intended to
immobilize the fracture site and limit weight bearing, or load bearing.
The patient is to be fully aware and warned that the device does not
replace normal healthy bone, and that the device can break, bend or
be damaged as a result of stress, activity, load bearing, or weight
bearing. The patient should be made aware of general surgical
risks, possible adverse activity, and to follow instructions of the treating
physician. The patient should be advised of the need for regular
postoperative examinations as long as the device remains implanted.
7. Do not attempt fixation within a fracture line. Adequate fixation and
healing will be compromised if placed within fracture line.
8. Remove items from the sterile package using aseptic technique.
9. Always use a drill guide when drilling bone for placement of the
DynaClip Bone Fixation System implant.
10. Use of the DynaClip Bone Fixation System on poor quality bone may
lead to fixation failure or migration of the implants.
11. When using the DynaClip Bone Fixation System, care must be taken in
ensuring that critical structures such as blood vessels and nerves do
not abut against the edges of the implant.
7. PRECAUTIONS
Do not reuse implants. While an implant may appear undamaged,
previous stress and handling may have created imperfections that would
reduce the service life of the implant. Do not treat patients with implants
that have been even momentarily in a different patient.
The DynaClip instrumentation is available to aid in the accurate
implantation of the DynaClip Bone Fixation System implant. These
instruments are sterile packed and are single-use only. These instruments
should only be used for their intended purpose.
8. POSSIBLE ADVERSE EFFECTS
1. Nonunion or delayed union which may lead to breakage of the implant.
2. Bending or fracture of the implant.
3. Loosening or migration of the implant.
4. Metal sensitivity or allergic reaction to a foreign body.
5. Limb shortening due to compression of the fracture or bone resorption.