BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX AB CURVED NEEDLE DELIVERY SYS.

    MDR report key: 1070783 · Received July 3, 2008

    Report

    Report Number
    1219602-2008-00160
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 5, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING USE IN SURGERY THE SUTURE KNOTS FAILED. IT WAS CONFIRMED THAT T1 WAS LEFT IN THE JOINT UNSUPPORTED AND THAT BACK-UP DEVICES WERE AVAILABLE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX AB CURVED NEEDLE DELIVERY SYS. FAST -FIX AB GAS SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7209399 50236438

    Patients

    Seq Age Sex Outcome Treatment
    1