BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 1853482 · Received September 28, 2010

    Report

    Report Number
    1811755-2010-01268
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE CORD WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION. BASED ON THE QUALITY ASSURANCE INVESTIGATION DETAILS, THE REPORTED CONDITION OF THE CORD CAUSING HANDPIECES TO OVERHEAT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS HANDPIECE CORD CAUSED A MICRO HANDPIECE TO OVERHEAT WHEN IT WAS USED DURING AN ANKLE SURGERY. WHEN ANOTHER HANDPIECE CORD WAS USED, THE SAME HANDPIECE DID NOT OVERHEAT, AND THE PROCEDURE WAS COMPLETED WITH THAT BACKUP CORD. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS HANDPIECE CORD SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HWE STRYKER INSTRUMENTS KALAMAZOO 10137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK