BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEPUY MITEK ACL KIT

    MDR report key: 1032987 · Received April 21, 2008

    Report

    Report Number
    MW5006350
    Event Type
    Other
    Date Received
    April 21, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 21, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ORTHOPEDIC PHYSICIAN WAS REPLACING ACL TENDON IN PT, THE GUIDEWIRE/PIN BROKE IN THE PT'S FEMUR. DATES OF USE: 2008. DIAGNOSIS : ACL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY MITEK ACL KIT ACL KIT HRX DEPUY MITEK 3116472

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other