WRIGHT Salvation 153910-1, Руководство пользователя

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Recommendations Regarding Device Fragments
•
Use medical devices in accordance with their labeled indications and Wright Medical
Technology’s instructions for use, especially during insertion and removal.
• Inspect devices prior to use for damage during shipment or storage or any out-of-
box defects that might increase the likelihood of fragmentation during a procedure.
• Inspect devices immediately upon removal from the patient for any signs of breakage
or fragmentation.
• If the device is damaged, retain it to assist with Wright Medical Technology’s analysis
of the event.
• Carefully consider and discuss with the patient (if possible) the risks and benefits of
retrieving vs. leaving the fragment in the patient.
• Advise the patient of the nature and safety of unretrieved device fragments including
the following information:
a. The material composition of the fragment (if known);
b. The size of the fragment (if known);
c. The location of the fragment;
d. The potential mechanisms for injury, e.g., migration, infection;
e. Procedures or treatments that should be avoided such as MRI exams in the case of
metallic fragments. This may help to reduce the possibility of a serious injury from the
fragment.