Johnson & Johnson DePuy Synthes TRUESPAN Manual De Instrucciones página 3

• Physical conditions that would eliminate or tend to
eliminate adequate implant support or retard healing
(e.g., blood supply limitation, previous infection, etc.)
• Conditions which tend to limit the patient's ability
to restrict activities or follow directions during the
healing period.
• Meniscal tears not suitable for repair because of the
degree of damage to the meniscus body.
• Comminuted bone surface that would militate
against secure fixation of the implant.
• Known hypersensitivity to any of the implant
materials.
WARNINGS
• Users should be familiar with the orthopedic and
arthroscopic procedures and techniques for repair
of meniscal tissue before using the TRUESPAN
Meniscal Repair System.
• Injury could result if device is not positioned
correctly.
• Do not re-sterilize. The TRUESPAN Meniscal Repair
System is provided sterile for single-use only. This
product has not been designed to be re-used/
re-sterilized. Reprocessing may lead to changes in
material characteristics deformation and material
degradation which may impact the strength of
the device and compromise device performance.
Reprocessing of single-use devices can also cause
cross-contamination leading to patient infection.
These risks may potentially affect patient safety.
PRECAUTIONS
• Do not remove the adjustable depth stop from the
applier during use.
• Review Instructions for Use prior to use.
• Contents are STERILE unless sterile packaging is
damaged or opened. Do not use if sterile packaging
appears to be damaged.
• Users should exercise caution when handling
surgical needles to avoid inadvertent needle sticks.
• After use, the applier may be a potential biohazard/
sharps hazard and should be handled in accordance
with accepted medical practice and applicable local
and national requirements.
• Use caution when tensioning the suture. Over-
tensioning may cause tissue damage and/or suture
or implant breakage.
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