XIROS FlexPasser Instrucciones De Uso página 4

Step 4.
The full thickness of one leg of the sleeve is cut across
obliquely (Figure B) at the base of the tapered segment.
The oblique cut creates a larger entry point for the tendon
than a transverse cut.
Step 5.
The leg that has not been cut can be removed from the
digit, leaving a single sleeve in place (Figure C).
Step 6.
The proximally retracted flexor tendon stump is sutured
using the surgeon's preferred technique for the repair,
leaving the suture ends long enough for retrieval. The
needle is to be kept on the suture (Figure D).
Step 7.
The free end of the suture is introduced into the open end
of the needle carrier to about 4-5 cm. Then, using a needle
holder, the entire body of the curved needle is introduced
in the carrier antegrade (Figure D), gently curving the
carrier to preserve the needle tip.
Step 8.
The Integrated probe and needle carrier is threaded
through the plastic sleeve from the proximal to distal
incisions and removed at the distal incision (Figure E),
once the needle and suture have been passed through the
sleeve they can be released from the carrier (Figure F).
Step 9.
We recommend that a small volume of saline should be
used to lubricate the sleeve and tendon prior to passing
the tendon through the plastic sleeve lining the sheath.
Gentle traction is applied to both ends of the suture
(Figure F), whilst the plastic sleeve is held in place with
forceps at the proximal incision, to guide the proximal
tendon stump(s) through the cavity of the sleeve and to
the distal wound (Figure F).
The following steps are not illustrated
Step 10.
Keeping tension on the suture, the sleeve is then pulled
from the distal wound out of the tendon sheath thus
freeing both ends of the suture in readiness for the tendon
repair.
The two stumps can now be connected by continuing the
chosen repair technique with the same needle and suture
material.
If the FDP and FDS both require repair, then they should
be placed in the anatomic orientation prior to proceeding
as per steps 6 – 10. One suture pair at a time should be
passed through the plastic sleeve. Then the four suture
strands are used to draw the two tendons simultaneously
to the distal incision where each can be sutured to its
own stump.
Disposal
No specific disposal requirements other than handling
contaminated items as clinical waste.
Complaints
Any health care professional who has any complaints
or experienced any dissatisfaction in the product
quality, identity, durability, reliability, safety, usability,
effectiveness, and/or performance, should notify the
manufacturer and distributor immediately.
If the product ever malfunctions and may have caused
or contributed to the death or serious injury of a patient,
the manufacturer and relevant local regulatory authority
should be notified immediately by telephone, email or
written correspondence.
When filing a complaint, provide the component(s) name
and number, lot number(s), your name and contact details
and the nature of the complaint.