BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HRIS FLEXIBLE OSTEO .12X120MM

    MDR report key: 1594638 · Received February 2, 2010

    Report

    Report Number
    2249697-2010-00116
    Event Type
    Malfunction
    Date Received
    February 2, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PATIENT EVENT AS MDR 224969-2010-00017.

    Description of Event or Problem · 1

    REPORTED VIA FDA, A PATIENT HAD SURGERY FOR REMOVAL OF IMPLANTED HARDWARE FROM LEFT KNEE. DURING THE PROCEDURE, TWO 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. DEVICE USING PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HRIS FLEXIBLE OSTEO .12X120MM INSTRUMENT HWM STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other