BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM

    MDR report key: 3831816 · Received March 6, 2014

    Report

    Report Number
    8031000-2014-00117
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 11, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM TRIGGER HANDLE DID NOT ALLOW FOR FIRM CAPTURE OF THE PIN. THE SURGEON HAD SWITCHED THE KEY CHUCK IN ORDER TO DRIVE THE PIN. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134798 UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM UNIVERSAL WIRE DRIVER, MICROMETRIC, 1-4MM HTO ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1