BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE SAG SAW

    MDR report key: 1813030 · Received August 12, 2010

    Report

    Report Number
    1811755-2010-00936
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURE FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS A CORRODED MOTOR AND GRITTY BEARINGS. THOSE PARTS WERE EACH REPLACED ALONG WITH THE PRESS PLUG, SAG HEAD, AND OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING TESTING AT THE ACCOUNT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED 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