BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE

    MDR report key: 1760171 · Received July 12, 2010

    Report

    Report Number
    2249697-2010-00824
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: SBYK05. DEVICE MANUFACTURE DATE FOR LOT SBYK05: 8/3/2010. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS: MFR # 2249697-2010-00818, MFR # 2249697-2010-00819, MFR # 2249697-2010-00820, MFR # 2249697-2010-00821, MFR # 2249697-2010-00822, MFR # 2249697-2010-00823, MFR # 2249697-2010-00825, MFR # 2249697-2010-00825.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ALL THESE ITEMS, WITH THE GREEN HANDLE, THE GREEN HANDLE IS DISINTEGRATING. (ALMOST LIKE THEY ARE MELTING, RUB HAND ON IT THE GREEN COMES OFF IN YOUR HAND.) REWASHED AND RESTERILIZED AND IT IS STILL HAPPENING. NOT SURE IF IT IS A PROCESSING ISSUE. AUTOCLAVE GOES TO 270 DEGREES FOR 50 MINUTES AND THEY USE A STERIS CLEANING AGENT. SEVERAL DIFFERENT TRAYS, ALL IN ONE LOAD, WASHED AND PROCESSED AT THE SAME TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SBZC12

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other