BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZATION SCREW, 3MM DIA X 16MM LGTH

    MDR report key: 1081569 · Received July 25, 2008

    Report

    Report Number
    9615741-2008-00012
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 25, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WILL NOT BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT AS THE SCREW WAS BEING PLACED THE DISTAL THREADS BROKE OFF THE SCREW. THE SCREW WAS LEFT IN PLACE IN THE SURGICAL SITE. IN A TELEPHONE CALL THE SURGEON STATED THAT THE PROCEDURE WAS FOR CORRECTION OF A BUNION DEFORMITY OF THE LEFT FOOT. HE STATED THAT THE DEVICE MALFUNCTION WAS NOT LIKELY TO ADVERSELY AFFECT THE OUTCOME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZATION SCREW, 3MM DIA X 16MM LGTH LOWER EXTREMITY FIXATION SCREW HWC NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1