BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SINGLE TRIGGER ROTARY

    MDR report key: 3013154 · Received March 20, 2013

    Report

    Report Number
    0001811755-2013-00558
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REPAIRED AND RETURNED.

    Description of Event or Problem · 1

    THE SYSTEM 7 SINGLE TRIGGER ROTARY WAS RETURNED TO STRYKER INSTRUMENTS FOR EVALUATION DUE TO ALLEGEDLY FINDING AN UNKNOWN SUBSTANCE ON THE BLACK PLATE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116015 SYSTEM 7 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1