BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX AB REVERSE CURVED

    MDR report key: 1360170 · Received January 8, 2009

    Report

    Report Number
    1219602-2009-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2009
    Report Date
    December 9, 2008
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIVISION
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A MENISCAL REPAIR T2 WOULD NOT DEPLOY. IT WAS CONFIRMED THAT T1 WAS LEFT IN THE PATIENT UNSUPPORTED AND THAT ADDITIONAL FAST-FIX WAS USED TO COMPLETE THE REPAIR. NO DELAY OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA FAST-FIX AB REVERSE CURVED ULTRA FAST-FIX AB GAS SMITH & NEPHEW INC. ENDOSCOPY DIVISION 72201495 50244774

    Patients

    Seq Age Sex Outcome Treatment
    1