GMM-632L

Image of the Maxon™ suture product in its packaging

Indications, Safety, and WarningsIndications
Maxon™ and Maxon™ CV sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.Actions
Maxon™ and Maxon™ CV synthetic absorbable sutures elicit a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of Maxon™ and Maxon™ CV synthetic absorbable sutures occurs by means of hydrolysis where the suture is broken down and subsequently absorbed and metabolized by the body.Studies indicate that tensile strength for Maxon™ and Maxon™ CV sutures is approximately 80% of the original suture strength at one week post implant. Approximately 75% of the original suture strength remains at two weeks, 65% at three weeks, 50% at four weeks, and 25% at six weeks post-implant. Absorption of Maxon™ and Maxon™ CV synthetic absorbable sutures is minimal until about the sixtieth day after implantation. Absorption is substantially complete within six months.Contraindictions

The use of this suture is contraindicated in patients with known sensitivities or allergies to its components.

This suture, being absorbable, should not be used where extended approximation of tissue is required or fixation of permanent cardiovascular prostheses or synthetic grafts.

Warnings

This device is provided sterile, for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.

In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other, suture with salt solutions, as calculus formation may result.

Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Maxon™ and Maxon™ CV synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.

Acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.

The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.

The use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.

Precautions

Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

In handling this or any other suture material care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted be surgical circumstances and the experience of the surgeon.

The use of additional throws may be particularly appropriate when knotting monofilaments.

Care should be exercised when knotting sutures used in continuous mass or layered closure of the abdomen, i.e., non-slip locking knots should be used at both ends of the continuous closure.

The commonly used looped-to-stand knot during termination of a running suture is a configuration, which may lead to slippage. Extreme care must be used to ensure that multiple square knots are well secured.

Sutures in vaginal mucosa or skin, that remain in place for extended periods may be associated with localized irritation and should be removed as indicated.

Since any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, standard surgical practice should be followed with respect to drainage and closure of infected wounds.

Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements.

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