BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARSY

    MDR report key: 2941969 · Received December 21, 2012

    Report

    Report Number
    1811755-2012-04339
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SYS 6 DUAL TRIGGER ROTARY WAS SENT FOR SVC AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THE DEVICE RAN IN FORWARD WHILE IN REVERSE MODE. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TRIGGER ROTARSY KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK