BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 2970791 · Received February 20, 2013

    Report

    Report Number
    8030965-2013-00573
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE RETURNED TO SYNTHES (B)(4) - DATE UNKNOWN. DEVICE WAS EVALUATED BY SYNTHES (B)(4): RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED; THE UNIT DID NOT RUN IN THE LOCKED POSITION DURING TESTING. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRIC PEN DRIVE RUNS IN LOCKED POSITION. THE REPORT WAS NOT RELATED TO A SURGERY. THE EVENT OCCURRED IN (B)(6) 2012. THIS IS 1 OF 1 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74295 ELECTRIC PEN DRIVE 60,000 RPM ELECTRIC PEN DRIVE DZI SYNTHES GMBH 0599

    Patients

    Seq Age Sex Outcome Treatment
    1