BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAM 4.3MM SCREWDRIVER AXIS

    MDR report key: 2440470 · Received January 19, 2012

    Report

    Report Number
    9615741-2012-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 19, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INDICATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SCREWDRIVER BROKE DURING USE IN A SURGICAL PROCEDURE. THE SURGEON WAS ATTEMPTING TO IMPLANT A SCREW, AND WAS NOT USING FORCE WHEN THE TIP OF THE SCREWDRIVER BROKE. THERE WAS NO ADVERSE OUTCOME FOR THE PT. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAM 4.3MM SCREWDRIVER AXIS QUIX HXX NEWDEAL SAS E52G

    Patients

    Seq Age Sex Outcome Treatment
    1