BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.

    MDR report key: 24873497 · Received April 14, 2026

    Report

    Report Number
    3010692967-2026-00010
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 14, 2026
    Manufacturer
    SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STERILE SAMPLES FROM THE REPORTED LOT, INCLUDING THE ACTUAL DEVICES, WERE NOT RETURNED FOR VISUAL REVIEW OR ANALYSIS. WITHOUT THE ACTUAL REPORTED DEVICES, PHOTOS OF THE DEVICES, OR DETAILED INFORMATION ON THE METHOD USED TO REMOVE THE DEVICE FROM THE PACKAGING, PREOPERATIVE PREPARATION OF THE DEVICE, OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. BASED ON OUR REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT DEVICE, THERE WERE NO RECORDED NONCONFORMANCES, DEVIATIONS, OR OTHER MANUFACTURING ANOMALIES THAT COULD ACCOUNT FOR THE REPORTED FAILURE. ALL PRODUCTION AND INSPECTION PROCESSES WERE COMPLETED IN ACCORDANCE WITH SPECIFIED REQUIREMENTS, AND NO IRREGULARITIES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THE DEVICE'S FUNCTIONALITY OR QUALITY. REVIEW OF LABELING: INDICATION - STERNOTOMY SUTURES ARE INTENDED FOR - STERNAL CLOSURE, ABDOMINAL WOUND CLOSURE, HERNIA REPAIR, AND ORTHOPEDIC PROCEDURES INCLUDING CERCLAGE AND TENDON REPAIR. APPLICATION - THE NEEDLE AND THREAD COMBINATION TO BE USED IS SELECTED ACCORDING TO THE CONDITION OF WOUND, PATIENT, AREA OF APPLICATION, SURGICAL TECHNIQUE BEING APPLIED, AND CORRESPONDING WITH THE EXPERIENCE OF THE SURGEON. ACTION - STERNOTOMY SUTURES ARE OF HIGH-GRADE STAINLESS STEEL OR TITANIUM THAT CAN TRIGGER A MINIMAL ACUTE INFLAMED REACTION IN THE TISSUES. ABSORPTION DOES NOT OCCUR. CONTRAINDICATIONS - STERNOTOMY SUTURES ARE CONTRAINDICATED IN PATIENTS WITH KNOWN SENSITIVITIES OR ALLERGIES TO STEEL AND/OR ITS PRINCIPAL METALLIC COMPONENTS, CHROMIUM AND NICKEL. WARNINGS/PRECAUTIONS - SINCE THE RISK OF WOUND DEHISCENCE IS DEPENDENT ON THE AREA OF THE BODY AND SUTURE MATERIAL BEING INSERTED, THE USER SHOULD BE FAMILIAR WITH SURGICAL METHODS AND TECHNIQUES BY WHICH MEANS SUTURES ARE USED FOR SEALING WOUNDS. IN THE EVENT OF DRAINAGE, OR CLOSURE OF INFECTED OR CONTAMINATED WOUNDS, GENERALLY ACKNOWLEDGED SURGICAL TECHNIQUES MUST BE FOLLOWED. IN GENERAL, WHEN USING STERNOTOMY SUTURES, YOU SHOULD ENSURE THAT THE SUTURE MATERIAL IS NOT DAMAGED OR SQUASHED BY SURGICAL INSTRUMENTS SUCH AS FORCEPS. NEEDLE-HOLDERS OR TWEEZERS, SINCE THIS COULD RESULT IN NEGATIVE CHANGES IN THE TENSILE STRENGTH OF THE SUTURE MATERIAL AND IN ITS SAFETY. ACCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED FOR MANAGEMENT OF INFECTED OR CONTAMINATED WOUNDS. THE IMAGE PRODUCED BY MR IMAGING EQUIPMENT COULD BE DISTORTED IN PATIENTS WITH STAINLESS STEEL SUTURES. THERE IS MINIMAL RISK OF SUTURE MOVEMENT DURING PROCEDURES USING MR IMAGING EQUIPMENT. WHEN USING STERNOTOMY SUTURES, YOU SHOULD ENSURE THAT YOU GRIP THE MIDDLE OF THE NEEDLE AND DO NOT DAMAGE EITHER THE POINT OR ARMED END OF THE NEEDLE WITH SURGICAL INSTRUMENTS LIKE TWEEZERS OR NEEDLE HOLDERS, SINCE THIS CAN CAUSE THE NEEDLE TO BEND OR BREAK. WHEN SEPARATING THE NEEDLE FROM SUTURE WIRE SUITABLE FORCEPS SHOULD BE USED AND THE SEPARATION MUST OCCUR AT A DISTANCE OF AT LEAST 4-5 CM FROM THE END OF THE NEEDLE SHAFT. IN GENERAL, SURGICAL NEEDLES SHOULD BE HANDLED WITH METICULOUS CARE WHEN IN USE IN ORDER TO AVOID NEEDLE-PRICK INJURIES TO PATIENT AND USER. SUITABLE CONTAINERS MUST BE USED FOR THE DISPOSAL OF NEEDLES. RE-USE COULD LEAD TO A NEGATIVE FUNCTIONAL, IMMUNOLOGICAL, TOXICOLOGICAL OR HYGIENIC IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 20 MARCH 2026 THAT DURING USE THE NEEDLE TIP BROKE OFF, FELL INTO THE PATIENT AND WAS RETRIEVED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930303 SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. STERNOTOMY SUTURE GAB SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. SK1-545-4 E403LSU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown