BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION HANDLE

    MDR report key: 1805455 · Received August 10, 2010

    Report

    Report Number
    2249697-2010-01040
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 26, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT# CRZK01, DEVICE MANUFACTURE DATE: 10/25/2005. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR #2249697-2010-01041.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "INSTRUMENTS WERE WASHED AND STERILIZED IN THE SAME MANNER AS ALWAYS, BUT FOR SOME REASON THE RUBBER WAS AFFECTED. THE RUBBER HANDLES ARE NOW SOFT AND STICKY. THE CASE WAS CANCELLED DUE TO THIS. I WILL BE FAXING THE HOSPITAL'S STERILIZATION PARAMETERS AND THE AGENTS USED TO CLEAN AND STERILIZE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA N2T03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other