PKGI-79-F Effective 03-2019
The user must refer to the instrument's label to determine
whether the instrument is single use or reusable. Single use
instruments are labeled with a "do not re-use" symbol as
described in the Symbol Legend section, below.
Single use instruments must be discarded after a single use.
Reusable instruments have a limited lifespan. Prior to and
after each use, reusable instruments must be inspected
where applicable for sharpness, wear, damage, proper
cleaning, corrosion and integrity of the connecting
mechanisms. Particular care should be paid to drivers, drill
bits and instruments used for cutting or implant insertion.
SURGICAL TECHNIQUES:
Surgical techniques are available
describing the uses of this system. It is the responsibility of the
surgeon to be familiar with the procedure before use of these
products. In addition, it is the responsibility of the surgeon to be
familiar with relevant publications and consult with experienced
associates regarding the procedure before use. Surgical
techniques can be found on the Acumed website (acumed.net).
IMPLANT WARNINGS:
For safe effective use of the implant,
the surgeon must be thoroughly familiar with the implant, the
methods of application, instruments, and the recommended
surgical technique for the device. The device is not designed to
withstand the stress of weight bearing, load bearing, or excessive
activity. Improper insertion of the device during implantation can
increase the possibility of loosening or migration. The patient must
be cautioned, preferably in writing, about the use, limitations, and
possible adverse effects of this implant. These cautions include
the possibility of the device or treatment failing as a result of loose
fixation and/or loosening, stress, excessive activity, or weight
bearing or load bearing, particularly if the implant experiences
increased loads due to delayed union, nonunion, or incomplete
healing, and the possibility of nerve or soft tissue damage related
to either surgical trauma or the presence of the implant. The
patient must be warned that failure to follow postoperative care
instructions can cause the implant and/ or treatment to fail. The
implants may cause distortion and/or block the view of anatomic
structures on radiographic images. The components of this
system have not been tested for heating, migration, or image
artifact in the MRI environment. The safety of these devices in the
MR environment is unknown. Scanning a patient who has these
devices may result in patient injury
.
Similar products have been
tested and described in terms of how they may be safely used in
post-operative clinical evaluation using MRI equipment
1
.
1
Shellock, F. G. Reference Manual for Magnetic Resonance Safety, Implants, and
Devices: 2011 Edition. Biomedical Research Publishing Group, 2011.
SURGICAL INSTRUMENT WARNINGS:
For safe effective use
of any Acumed instrument, the surgeon must be familiar with the
instrument, the method of application, and the recommended
surgical technique. Instrument breakage or damage, as well as
tissue damage, can occur when an instrument is subjected to
excessive loads, excessive speeds, dense bone, improper use or
unintended use. The patient must be cautioned, preferably in
writing as to the risks associated with these types of instruments.
IMPLANT PRECAUTIONS:
An implant shall never be reused.
Previous stresses may have created imperfections, which can
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US
Summary of Contents for Ankle Plating System 3
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