ETHILON M22296FR Polyamide 6 Nylon Suture Instruction Manual
- June 17, 2024
- ETHILON
Table of Contents
ETHILON M22296FR Polyamide 6 Nylon Suture
DESCRIPTION
ETHILON™ suture thread is a sterile non-absorbable synthetic monofilament for surgical use composed of polyamide 6 [NH-CO (CH2)5]n or of polyamide 6,6 [NH-(CH2)6-NH-CO-(CH2)4-CO]n.
ETHILON™ suture thread is available in colorless or colored black by the addition of hematein HCK (color index number 75290), or colored green by the addition of D&C Green No. 5 (color index number 61570 ) to improve visibility in the surgical field.
ETHILON™ Suture Thread is available in a range of gauges and lengths, needleless or crimped onto needles of varying types and sizes, in the various presentations described in the PACKAGING section.
ETHILON™ suture thread complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile polyamide 6 or polyamide 6,6 sutures and the United States Pharmacopoeia (USP) for non-absorbable surgical sutures. The European Pharmacopoeia recognizes metric and Ph. Eur units of measurement. as equivalent, which is reflected in the labeling.
INDICATIONS
ETHILON™ suture is indicated for soft tissue approximation and/or ligation, including during cardiovascular and ophthalmic surgery and neurosurgery procedures.
APPLICATION
The choice and implantation of the suture depends on the patient’s condition, the experience of the surgeon, the surgical technique and the size of the wound.
MODE OF ACTION
ETHILON™ suture triggers a mild initial inflammatory reaction in the tissues, followed by gradual encapsulation of the suture by fibrous connective tissues. Although polyamide is non-absorbable, u Gradual hydrolysis in vivo can result in a progressive loss of its tensile strength over time.
CONTRAINDICATIONS
Due to the possibility of a gradual decrease in tensile strength that can
occur after long periods in vivo, the wire
ETHILON™ suture should not be used when permanent maintenance of tensile
strength is required.
WARNINGS
The user should be familiar with the surgical procedures and techniques
relating to the use of non-absorbable sutures before using ETHILON™ sutures
for wound closure, as the risk of wound dehiscence depends on the surgical
site and the nature of the suture. For any surgical procedure, take the
necessary measures to control wound contamination or infection.
Do not re-sterilize/reuse. Reuse of this device (or parts of this device) may
create a risk of product degradation, which may lead to device failure and/or
cross-contamination, which may result in infection or transmission of
pathogens transmitted through blood to patients and users. Like any foreign
body, this product can aggravate an existing infection.
PRECAUTIONS
As with all sutures, special care should be taken when handling the thread. Do
not pinch or crush the wire using a surgical instrument such as forceps or a
needle holder.
As with all sutures, to ensure proper knot security, the suture should be used
in accordance with usual flat square surgical suture and knot techniques with,
possibly, additional stitches depending on the surgical circumstances and the
experience of the surgeon. It is particularly recommended to make additional
stitches with monofilaments.
Precautions must be taken to avoid damaging the needles. Grasp the needle in
the space between a third (1/3) and a half (1/2) of the body, thread side. Do
not pinch the tip, which could modify the penetration characteristics of the
needle and cause it to break. Do not grasp the needle by the crimping area,
which could cause a risk of twisting or breakage. Do not modify the shape of
the needle so as not to modify its resistance to curvature characteristics.
Users should take appropriate precautions when handling needles to avoid any risk of needlestick injury. A broken needle may result in prolonged surgery, additional intervention, or the presence of a residual foreign body. Accidental needlesticks from contaminated surgical needles can result in the transmission of bloodborne pathogens. Dispose of used needles in designated sharps containers.
SIDE EFFECTS
Adverse effects associated with the use of this device include wound dehiscence, gradual decrease in tensile strength over time, formation of stones in the urinary and biliary tract upon prolonged contact with saline solutions such as urine or bile, a weak acute inflammatory tissue reaction and transient local irritation at the wound site.
STERILITY
ETHILON™ sutures are sterilized by irradiation. Do not re-sterilize. Do not use if package is opened or damaged. Discard unused open sutures.
CONSERVATION
No storage conditions required. Do not use after the date of expiry.
CONDITIONING
Please note that not all sizes are available in all markets. Please contact your local representative for size availability.
ETHILON™ Sutures are available as sterile monofilament strands in USP sizes 11-0 through 2 (metric sizes 0.1–5.0) in various lengths with or without permanently attached needles. Sutures are also available in presentations containing the following:
- Lead stitch for crimping and surgical drone in which the lead stitch serves to ensure the position of the drone relative to the stitch in order to maintain adequate tension.
- Retention tubing (elastomeric) used to distribute the load of the suture to the skin surface.
ETHILON™ suture thread is available in boxes of twelve, twenty-four or thirty- six units.
For recognized legal manufacturer, refer to product label.
| Do not re-use
---|---
| Use-by date
| Batch code
| Sterilized using irradiation
| Sterilized by irradiation
| Catalogue Number
| Caution
| Manufacturer
| Do not restabilize
| Authorized Representative in the European Community
| Do not use if package is damaged
| Number of Units
| Multi-strand
| PEEL/LIFT/OPEN HERE
| TEAR HERE
IFU PRINTING SPECIFICATION SHEET
Customers Support
100601593 | Rev:2
Released: 08 Jan 2020
CO: 100747102
Release Level: 4. Production
ETHICON, LLC
475 C Street
Los Frailes Industrial Park
Suite 401
Guaynabo, Puerto Rico 00969
USA
1-877-ETHICON
+1-513-337-6928
ETHICON, LLC
Highway 183 Km 8.3
San Lorenzo, Puerto Rico 00754
USA
1-877-ETHICON
+1-513-337-6928
