BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMORAL BROACH SZ 1

    MDR report key: 2505123 · Received March 21, 2012

    Report

    Report Number
    1651501-2012-00026
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    UNK PIECE OF METAL RESEMBLING SHORT PIN FELL INTO THE SURGICAL SITE FROM UNK INSTRUMENTATION IN THE HRA SET. THE PIN WAS EASILY REMOVED WITHOUT DAMAGE TO ANY TISSUE. ADD'L INFO OBTAINED FROM REPORTER. "NO BREAKAGE OF PINS," "NO PT HARM," "NO DELAY IN SURGERY." THERE WAS NO INFO KNOWN ABOUT POST-OP X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMORAL BROACH SZ 1 TITAN HRA INSTRUMENTS HTQ ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1