DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 5

The DynaNail TTC Fusion Nail has not been evaluated for safety and compaMbility
in the MR environment. It has not been tested for heaMng or migraMon in the MR
environment.
5. PRECAUTIONS
The DynaNail TTC Fusion System should only be used by those physicians who
have been trained in the appropriate, specialized procedures. Knowledge of
appropriate surgical techniques, instrumenta@on, proper selec@on and placement
of implants and postopera@ve pa@ent care and management are essen@al to a
successful outcome.
Correct selecMon of the DynaNail TTC Fusion Nail and device components is
extremely important. Carefully select the appropriate DynaNail Screw sizes based
on the needs of each individual pa@ent. For best results, always use the largest
possible components and ensure that the components are properly posi@oned.
Failure to do so may result in loosening, bending, cracking or fracture of the device
or injury to the pa@ent’s bone or both.
Always handle the DynaNail TTC Fusion Nail carefully. The surface of the implant
must always be protected from damage during handling. Avoid contac@ng the
implant with other tools or materials that could notch, scratch or otherwise
damage the implant surface. Damage to the implant’s surface finish may result in
loss of proper mechanical func@on of the device.
Never aTempt to reuse. Once the DynaNail TTC Fusion Nail, DynaNail End Cap, and
DynaNail Screws have been removed from the packaging, the device should be
either used or discarded. Never aZempt to reuse the Nails, End Cap, and/or Screws,
even though they may appear undamaged.
The surgeon must make the final decision regarding implant removal. In the
absence of a bursa or pain, removal of the implant in elderly or debilitated pa@ents
is not recommended. Extreme care must be taken when following the technique
for removal of the device.
Use only DynaNail TTC Fusion System components. The DynaNail TTC Fusion
System components manufactured by MedShape must not be used in conjunc@on
with screws, wire bands, or other metallic devices manufactured by any other
manufacturer, as component parts may not be compa@ble.
6. POTENTIAL ADVERSE EFFECTS
Poten@al adverse effects resul@ng from the use of the DynaNail TTC Fusion System
include, but are not limited to, the following:
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Loosening, bending, cracking or fracture of the implant components.
Loss of fixa@on in bone aZributable to nonunion, osteoporosis and/
or markedly unstable comminuted fractures.
Limb shortening or loss of anatomic posi@oning with nonunion or malunion
with rota@on or angula@on.
Deep or superficial infec@on.