BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2033688 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00918
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE WAS RUNNING WITHOUT ACTIVATION. FURTHER INVESTIGATION REVEALED CORROSION DAMAGE TO THE PRESS PLUG, AND THE BEARING. A MALFUNCTIONING MID SPEED MOTOR CARTRIDGE WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED, CLEANED, LUBED, ADJUSTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A MICRO RECIPROCATING SAW WAS SENT IN FOR REPAIR BECAUSE IT WAS RUNNING WITHOUT ACTIVATION. THE EVENT OCCURRED DURING PREPARATION PRIOR TO A PROCEDURE; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE. ANOTHER DEVICE WAS USED TO DO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO RECIPROCATING SAW BONE CUTTING INSTRUMENT AND ACCESSORIES ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK