BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR SYS5 ROT DUAL TRIGGER

    MDR report key: 1841978 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01017
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. THE TRIGGER ASSEMBLY WAS BROKEN. THE HANDPIECE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNK PROCEDURE, THE HANDPIECE TRIGGER WAS STICKING IN REVERSE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES OR DELAY IN THE PROCEDURE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR SYS5 ROT DUAL TRIGGER INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK