BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOWMEDICA

    MDR report key: 1580560 · Received January 14, 2010

    Report

    Report Number
    1580560
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 14, 2010
    Manufacturer
    HOWMEDICA
    Product Code
    HWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD SURGERY FOR REMOVAL OF IMPLANTED HARDWARE FROM LEFT KNEE. DURING THE PROCEDURE 2 HOWMEDICA FLEXIBLE OSTEOTOMES BROKE. THE FIRST ONE LISTED AS CAT # 6210-0-710 BROKE AT THE SEAM BASE. THE SECOND ONE LISTED AS CAT # 6210-0-730 HAD A PIECE BREAK OFF OF THE TIP. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOWMEDICA OSTEOTOME, FLEXIBLE HWM HOWMEDICA * *
    2 HOWMEDICA OSTEOTOME, FLEXIBLE HWM HOWMEDICA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR