BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 1853855 · Received September 7, 2010

    Report

    Report Number
    1811755-2010-01058
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE ALLEGED COMPLAINT COULD NOT BE DUPLICATED. THE HANDPIECE WAS SERVICED AND RETURNED TO THE CUSTOMER. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED WITH THE HANDPIECE, CAUTIONS THE USER TO NOT IMMERSE A HANDPIECE, ATTACHMENT OR BATTERY PACK IN LIQUID. MOISTURE MAY ENTER THE EQUIPMENT, CAUSE CORROSION, AND DAMAGE THE ELECTRICAL AND/OR MECHANICAL COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING WATER. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCE RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK