BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX TI 5.0 MM RC

    MDR report key: 2020649 · Received March 16, 2011

    Report

    Report Number
    1219602-2011-00043
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION.(B)(6)

    Description of Event or Problem · 1

    THE ANCHOR THREADS STRIPPED DURING INSERTION; HARD BONE; UNABLE TO REMOVE SCREW; BROKE OFF THE TOP AND PUT IN AN ARTHREX ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX TI 5.0 MM RC TWINFIX TI 5.0 ULTRABRAID MBI SMITH & NEPHEW ENDOSCOPY 72200755 50357084

    Patients

    Seq Age Sex Outcome Treatment
    1