BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE SAG SAW

    MDR report key: 1902860 · Received November 12, 2010

    Report

    Report Number
    1811755-2010-01659
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE SAG HEAD AND BEARINGS, WHICH WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN WHEN CONNECTED TO THE CONSOLE DURING SET UP PRIOR TO THE START OF A SURGICAL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR CORE SAG SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK