Publicidad
Idiomas disponibles
Idiomas disponibles
English
Ordering Information (supplied sterile)
Part No. 202-1500
Description
The FlexPasser Tendon Retrieval Kit consists of two
components:
•
An integrated probe and needle carrier.
•
A plastic sleeve for lining the sheath of the severed
tendon.
The integrated probe and needle carrier consists of a
flexible elongated device with a smooth, semi rigid,
rounded end. At the other end there is a more flexible
section to allow for a curved needle and suture to be
transferred through the sheath. There is also a wire loop at
this end to which is attached the plastic sleeve. This sleeve
allows the probe and needle carrier, and then the tendon
to be passed through the tendon sheath from proximal to
distal without snagging.
Material Specification
The device is manufactured from Stainless Steel, Low-
Density Polyethylene (LDPE) and Fluorinated Ethylene
Propylene (FEP).
Intended Use
The FlexPasser Tendon Retrieval Kit is intended for use in
the retrieval of the proximal tendon stump(s) during the
repair of a lacerated digital flexor tendon(s) in the hand.
Indications for use
The FlexPasser Tendon Retrieval Kit is indicated for use in
patients undergoing repair of lacerated flexor tendons in
the hand.
Contraindications
The instrument must not be used for any procedure other
than the intended use.
Warnings
•
The device is for SINGLE USE only as it is not suitable
for reprocessing which amongst other risks may
lead to cross-infection, loss of function and patient
injury. Do not use after the expiration date. Discard
any open, unused product.
•
The devices included in this kit are NOT intended for
implantation.
•
The surgeon must be thoroughly familiar with
these instructions and the recommended surgical
procedure before using the device.
•
The general principles of patient selection and
sound surgical judgement apply.
•
The surgeon should give consideration to the
patient's hand size, as FlexPasser may not be
appropriate for smaller digits.
•
The instruments must be checked for damage prior
to use and are not to be used if there are any signs
of visible damage.
•
The device should not be used in patients with a
known sensitivity to Stainless Steel, LDPE or FEP. If
the patient is suspected of having any foreign body
sensitivity, appropriate tests should be made prior
to use.
•
Caution should be used when introducing the
needle into the carrier. Use of needle holders is
recommended to avoid needle prick injuries.
Precautions
•
Inspect the device, packaging and labelling prior to
use and do not use if damaged.
•
Avoid damage when handling the FlexPasser Tendon
Retrieval Kit. Avoid crushing or crimping when using
surgical instruments such as forceps or needle
holders.
•
Use only needles between 11 mm and 26 mm in
length, needles outside this range have not been
approved for use with this product. Some needle sizes
may be too large for the patient.
•
We recommend a needle with a 3/8 circumference,
although a small needle with 4/8 circumference may
still pass.
•
Use sterile technique throughout the procedure.
Packaging
•
The instruments are supplied sterilized by gamma
irradiation in a double pouch.
•
Packages should be intact upon receipt and once
the seal on the sterile package has been broken, the
product SHOULD NOT BE RE-STERILIZED.
•
Store in standard conditions.
•
Damaged packages or products should not be used
and should be returned to Xiros.
Potential Adverse Effects
Below is a list of the potential adverse effects (e.g.
complications) associated with the use of the device
including, 1) risks associated with any surgical procedure;
2) risks associated with flexor tendon retrieval and repair.
Additional surgery may be required to correct some of these
events.
1) Pertinent risks associated with any surgical procedure
include: Infection and wound dehiscence or scar
contractures due to incisions.
2) Risks associated with tendon retrieval and repair,
include: damage to the tendon and/or surrounding
tissue when retrieving the tendon; adhesions; rupture
of the repair; reduced active motion and disruption of
Camper's chiasm.
Surgical Technique
Step 1.
The proximal tendon stump is delivered to the palm
via a small incision in the crease of the palm (Figure A),
or proximal point of choice if the vinculum is to be
preserved. The palm is preferred, to minimise incisions on
the digit.
Step 2.
The finger should be gently extended. The probe is
advanced with its round end leading through the flexor
sheath, from the site of the distal flexor stump/opening in
the sheath to the site of the proximal flexor stump. Hold the
device close to the tip and advance in stages, maintaining
the orientation of the probe to avoid buckling and rotation
(Figure A).
Step 3.
Maintain the probe's orientation as it is pulled through the
proximal incision (Figure B), leaving the plastic sleeve in
place protruding from both incisions, ensure the sleeve has
not twisted before proceeding.
Publicidad
