DynaClip® Bone Fixation System- Instructions for Use | MedShape DynaClip® Bone Fixation System- Instructions for | Page 3

1. DEVICE DESCRIPTION
The MedShape DynaClip™ Bone Fixation System is intended for internal
fixation of small bones. The DynaClip Implant and Inserter comprise the
DynaClip Device System.
2. MATERIAL
Nickel-Titanium Alloy (NiTiNOL)
3. INDICATIONS FOR USE
The DynaClip Bone Fixation System is intended to be used for fracture
and osteotomy fixation and joint arthrodesis of the hand and foot.
4. PATIENT SELECTION
Patient selection factors to be considered include: 1) need for alignment
and stabilization of bone fractures, 2) ability and willingness of the patient
to follow postoperative care instructions until healing is complete, and 3) a
good nutritional state of the patient.
5. CONTRAINDICATIONS
1) Infection
2) Patient conditions including blood supply limitations, obesity, and
insufficient quantity or quality of bone.
3) Patients with mental or neurologic conditions who are unwilling or
incapable of following postoperative care instructions.
4) Foreign body sensitivity. Where material sensitivity is suspected, testing
is to be completed prior to implantation of device.
6. WARNINGS
Internal fixation devices aid the surgeon in the alignment and stabilization
of skeletal fractures and arthrodesis. While these devices are generally
successful in attaining these goals, they cannot be expected to replace
normal healthy bone or withstand the stress placed upon the device by
full or partial weight bearing or load bearing, particularly in the presence of
nonunion, delayed union, or incomplete healing. Internal fixation devices
are internal splints that aid in alignment of the fracture until normal
healing occurs. The size and shape of bones place limitation on the size
and strength of implants. If there is delayed union or nonunion of bone in
presence of weight bearing, or loading, the implant could eventually fail.
Therefore, it is important that protective measures including reduction
in activity and weight bearing and possible use of immobilization (use
of external support, walking aids, braces, etc.) of the fracture site be
maintained until firm bony union (confirmed by clinical and radiographic
examination) is established. Factors such as the patient’s weight, activity
level, and adherence to weight bearing or load bearing instructions have