BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPTIGHT ANKLE SYN SYS-SS

    MDR report key: 2810001 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02281
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK083070
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE SYNDESMOSIS THE ZIPTIGHT TOGGLELOC WOULD NOT TIGHTEN ALL THE WAY. THE SURGEON USED THE CORRECT SURGICAL TECHNIQUE BUT BEYOND A CERTAIN POINT THE TOGGLELOC WOULD NOT TIGHTEN ANY FURTHER. THE IMPLANT HAD TO BE REMOVED AND A DIFFERENT METAL IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPTIGHT ANKLE SYN SYS-SS FASTNER, FIXATION MBI BIOMET ORTHOPEDICS N/A 555370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R