BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GUAGE

    MDR report key: 3963485 · Received May 30, 2014

    Report

    Report Number
    9615741-2014-00028
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HRS
    PMA / PMN Number
    K083154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTER INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE GAUGE WAS TWISTED, MAKING THE READING DIFFICULT AND UNCERTAIN. THE SURGEON HAD DIFFICULTY TO GRIP THE OPPOSITE CORTICALE. HE PREFERRED USING A GAUGE BELONGING TO THE CLINIC. TIME OF THE SURGERY WAS SLIGHTLY INCREASED BECAUSE THE SURGEON REMOVED THE SUSPICIOUS SCREW TO MEASURE AGAIN WITH THE GAUGE FROM THE CLINIC. THE DEPTH MEASURED WAS FINALLY SIMILAR. BUT THE GAUGE TENDED TO TWIST ITSELF WHEN THE SURGEON TRIED TO GRIP THE CORTICALE AND IS NOT VERY SOLID COMPARED TO OTHER GAUGE. THERE WAS INJURY OR ADVERSE CONSEQUENCE REPORTED. NO SERIOUS INCREASE OF THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320223 DEPTH GUAGE NONE HRS NEWDEAL S.A. EKND

    Patients

    Seq Age Sex Outcome Treatment
    1