BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM

    MDR report key: 1082892 · Received July 25, 2008

    Report

    Report Number
    1219602-2008-00162
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT DURING ACL PROCEDURE, THE SURGEON IMPLANTED T1 AND WHEN THE SURGEON WENT TO DEPLOY T2, IT SLIPPED OFF THE DEVICE. THE SURGEON REMOVED THE SUTURE, BUT LEFT T1 UNSUPPORTED IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ADDITIONAL FAST-FIX DEVICE. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM FAST-FIX AB- ULTRABRAID GAS SMITH & NEPHEW INC., ENDOSCOPY DIV. 72201494 50253663

    Patients

    Seq Age Sex Outcome Treatment
    1