DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 4

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Pa@ents with significant @bial malalignment (>10 degrees in either sagiZal
or coronal plane).
Pa@ents with a dysvascular limb.
Pa@ents with severe longitudinal deformity.
Pa@ents with an insufficient quan@ty or quality of bone to permit fusion of the
joints or stabiliza@on of the arthrodesis.
Pa@ents with condi@ons that restrict his or her ability or willingness to follow
postopera@ve instruc@ons during the healing process.
Pa@ents with foreign body sensi@vity, suspected or documented metal allergy or
intolerance. Where material sensi@vity is suspected, appropriate tests should be
conducted and sensi@vity ruled out prior to implanta@on.
4. WARNINGS
The DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws are
supplied sterile for single use only.
DO NOT ATTEMPT TO RESTERILIZE. Resteriliza@on may result in loss of
proper mechanical func@on of the device and could result in pa@ent injury.
Carefully inspect product packaging and all device components for damage or
defects prior to use. Do not use any device if it appears defec@ve, damaged or
otherwise compromised.
The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed
to support the pa@ent’s body weight in the presence of a delayed union or
nonunion of bone. Un@l firm bony union is achieved, the pa@ent should employ
adequate external support and restrict physical ac@vi@es that would place stress
upon the implant or allow movement at the site and delay healing. Therefore, it is
important that immobiliza@on of the site is maintained un@l firm bony union
(confirmed by clinical and radiological examina@on) is established. Failure to
immobilize the ankle during healing may result in bending and/or breakage of
the device and/or failed fusion.
Do not modify the implant. Modified devices may not perform as intended and
could result in pa@ent injury.
The DynaNail TTC Fusion System is not approved for screw aZachment or fixa@on
to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. Use
of the implant or system components for these purposes may result in pa@ent
injury.
Serious postopera@ve complica@ons may occur from use of the implant in a
pa@ent who:
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Lacks good general physical condi@on.
Has severe osteoporosis.
Demonstrates physiologic or anatomic anomalies.
Has immunological responses, sensi@za@on or hypersensi@vity
to foreign materials.