MONOSTEEL   SURGICAL STEEL WIRE
NONABSORBABLE, SURGICAL SUTURE, USP/ Eur.Ph./TS7341

DESCRIPTION
Surgical stainless steel suture is a nonabsorbable, sterile surgical suture composed of AISI 316 LVM grade stainless steel conforming to ISO 5832 Part 1 “Metallic Materials for surgical implants”. Surgical stainless steel suture is available as a monofilament and multifilament suture.Surgical stainless steel suture meets all requirements established by the European Pharmacopoeia (E.P.) and the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical sutures. Surgical stainless steel suture may also be labelled with the Brown & Sharpe Gauge (B&S) or American Wire Gauge (AWG) classifications.
 

Polypropylene (PP) button, the accessory, is used for buttressing the suture thread to avoid cutting the tissue that the suture thread intended to be used on tendon repair . The set involving the button is also called 'Tendon Repair Kit Suture'. The curved side is the  top of the button. Flat side should be used to spread the suture tension by dermal touch.Another accessory is Polyethylene (PE) oval plate, which is, which is used for buttressing/cushioning the suture thread to avoid cutting the tissue and to spread the suture tension of where the suture thread intended to be used on abdominal closure. The set involving the plate is also called 'Retention Suture'. The plate consists of a hard high density polyethylene (HDPE) layer at the top, a low densisty polyethylene (LDPE) foam in the bottom layer which will be in touch with the area of application. Both layers are connected by double sided adhesive tape.
INDICATIONS
Surgical stainless steel suture is indicated for use as nonabsorbable  suture in tissue approximation such as abdominal wound closure, hernia repair, sternal
closure, and orthopaedic procedures including cerclage and tendon repair. MONOSTEEL is for single use only.
ACTIONS
Surgical stainless steel suture elicits a minimal acute inflammatory reaction in tissue and is not absorbed.
CONTRAINDICATIONS
The use of this suture is contraindicated in patients with known sensitivities or allergies to 316L stainless steel, nd/or its principal metallic components metals such as chromium and nickel.
WARNINGS
Users should be familiar with surgical procedures and techniques involving nonabsorbable, stainless steel sutures before employing for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.
Stainless steel sutures are not to be used in direct contact with the heart, the central circulatory system or the central nervous system.
Accessories are nonabsorbable, short term external use, not for inner body or cavity usage, only dermal touch. Do not resterilize. Discard opened, unused sutures.
PRECAUTIONS
In handling this or any other suture material, care should be taken to avoid damage from handling, such as kinking or excessive twisting. Acceptable surgical practice should be followed to place steel sutures sufficiently distal to wound edges to reduce the incidence of the suture cutting through tissue, when the wound is placed under extreme stress. Care should be taken to cut the knots/twists to allow for the bending of sharp ends away from surrounding tissue. Avoid damage to needle from handling. Grasping at the attachment area could cause breakage breakage of the needle barrel or the suture in the attachment area. Grasping  needle near the point could result in damage to fracture of the needle Reshaping needle may result in decrased resistance to bending and breaking. Avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens. Suitable containers must be used for disposal of needles.Dispose of contaminated suture and packaging materials utilizing standard hospital procedures and universal precautions for biohazardous waste.
ADVERSE REACTIONS
Adverse effects associated with the use of this device include wound dehiscence, allergic response in patients with known sensitivities to 316L stainless steel, or constituent metals such as chromium and nickel infection, minimal acute inflammatory tissue reaction, pain, oedema, and local irritation at the wound site. Needle breakage during surgery may result in extended anesthesia and/or surgery time, retention of foreign body in the patient, and/or additional surgery. Surgical stainless steel sutures are available in sizes 6-0  thru 7 (metric sizes 0.7-5.0) in a variety of pre-cut lengths with and without permanently attached needles by permanent needle attachment or rotating techniques, in one, two, and three dozen boxes. MONOSTEEL suture is supplied sterile.
STORAGE
Keep away from, sunlight. Protect from humidity. Do not use after expiry date.