BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI-CRON 2-0 STR W/10" SWGD NDL BX OF12

    MDR report key: 21820673 · Received April 10, 2025

    Report

    Report Number
    1219602-2025-00850
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    10884521105263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN REASSESSED BASED ON THE INFORMATION MADE AVAILABLE TO SMITH+NEPHEW (S+N). IT WAS DETERMINED THAT THIS EVENT NO LONGER FULFILL REPORTING REQUIREMENTS PER 21CFR803. SMITH+NEPHEW ACTS AS A DISTRIBUTOR OF THIS PRODUCT. THE LEGAL MANUFACTURER OF THIS PRODUCT IS MEDTRONIC (FORMERLY COVIDIEN). BASED ON THE QUALITY AGREEMENT SUBSCRIBED AMONGST BOTH PARTIES, THE LEGAL MANUFACTURER IS RESPONSIBLE FOR REPORTING EVENTS UNDER 21CFR803 FOR ANY AFFECTED PRODUCTS DISTRIBUTED BY S+N. AS A RESULT, THIS INCIDENT HAS BEEN ESCALATED TO THE MANUFACTURER ON 15-APR-2025.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BLUE SUTURE OF THREE (3) UNITS OF THE TI-CRON BROKE WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR'S DEVICE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910845 TI-CRON 2-0 STR W/10" SWGD NDL BX OF12 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 51236458 10884521105263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown