PKGI-79-F Effective 03-2019
lead to a device failure. Instruments shall be inspected for wear or
damage prior to usage. Protect implants against scratching and
nicking. Such stress concentrations can lead to failure. Bending
plates multiple times may weaken the device and could lead to
premature implant fracture and failure. Mixing implant
components from different manufacturers is not recommended for
metallurgical, mechanical and functional reasons. The benefits
from implant surgery may not meet the patient’s expectations or
may deteriorate with time, necessitating revision surgery to
replace the implant or to carry out alternative procedures.
Revision surgeries with implants are not uncommon.
SURGICAL INSTRUMENT PRECAUTIONS:
Single use
surgical instruments shall never be reused. Previous stresses
may have created imperfections, which can lead to a device
failure. Protect instruments against scratching and nicking, such
stress concentrations can lead to failure.
ADVERSE EFFECTS:
Possible adverse effects are pain,
discomfort, or abnormal sensations and nerve or soft tissue
damage due to the presence of an implant or due to surgical
trauma. Fracture of the implant may occur due to excessive
activity, prolonged loading upon the device, incomplete healing, or
excessive force exerted on the implant during insertion. Implant
migration and/or loosening may occur. Metal sensitivity,
histological, allergic or adverse foreign body reaction resulting
from implantation of a foreign material may occur. Nerve or soft
tissue damage, necrosis of bone or bone resorption, necrosis of
the tissue or inadequate healing may result from the presence of
an implant or due to surgical trauma.
CLEANING:
Implant Cleaning:
Implants should not be reused. Acumed
does not recommend cleaning of implants provided sterile.
Implants provided non-sterile that have not been used, but have
become soiled, should be processed according to the following:
Warnings & Precautions
Resterilization of the implants should not be performed if the
implant comes into contact with contamination (e.g. biological
tissue contact, such as bodily fluids/ blood) unless the single
use device (SUD) has been reprocessed by an authorized
facility who has received appropriate regulatory clearance for
such. Cleaning a SUD after it comes into contact with human
blood or tissue constitutes reprocessing.
Do not use an implant if the surface has been damaged.
Damaged implants should be discarded.
Users should wear appropriate personal protective equipment
(PPE).
All users should be qualified personnel with documented
evidence of training and competency. Training should be
inclusive of current applicable guidelines, standards and
hospital policies.
Manual Processing
Equipment: Soft bristled brush, neutral enzymatic cleaner or
neutral detergent with a pH ≤ 8.5.
1. Prepare a solution using warm tap water and detergent or
cleaner. Follow the enzymatic cleaner or detergent
manufacturer’s recommendations for use paying close
English – US / PAGE 5
US
Summary of Contents for Ankle Plating System 3
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