BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3604067 · Received February 3, 2014

    Report

    Report Number
    2520274-2014-00376
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DZI, ERL, HBE: ADDITIONAL CODES. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE HAS BEEN RETURNED AND IS ENTERING THE COMPLAINT SYSTEM. THE INVESTIGATION IS ONGOING. PLACEHOLDER.

    Description of Event or Problem · 1

    SYNTHES (B)(6) SERVICE COORDINATOR WAS ADVISED BY THE SALES CONSULTANT AND THE HOSPITAL REPORTER THAT DURING PLASTIC SURGERY, THE ELECTRIC PEN DRIVE 60,000 RPM HAS INTERMITTENT FUNCTION. THERE WAS 5 MINUTES DELAY TO RETRIEVE ANOTHER E-PEN DRIVE. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69951 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES USA 2609

    Patients

    Seq Age Sex Outcome Treatment
    1