BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2942079 · Received December 27, 2012

    Report

    Report Number
    1811755-2012-04352
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVAL THE MOTOR ASSEMBLY WAS FOUND TO BE DAMAGED AND A MOTOR WINDING SHORT WAS DISCOVERED, WHICH ARE PROBABLE CAUSES OF THE REPORTED OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK