BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE TRIGGER ROTARY

    MDR report key: 3902336 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02326
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS DUPLICATED. THROUGH INSPECTION, THE TRIGGER ASSEMBLY WAS NOTED TO BE MISSING FROM THE HANDPIECE. A TRIGGER HOUSING CRACK AT SCREW BOSS FAILURE WAS IDENTIFIED, WHICH CAN CAUSE OR CONTRIBUTE TO ISSUES WITH DISASSEMBLY.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE TRIGGER OF THE SINGLE TRIGGER ROTARY WAS MISSING WHILE IN THE STERILE PROCESSING DEPARTMENT OF THE USER FACILITY. AS THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379718 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1