BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRS-SCREW 24MM L X 3.0MM D

    MDR report key: 1111868 · Received August 12, 2008

    Report

    Report Number
    1818910-2008-03173
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K062352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY THE SCREW STRIPPED COULD NOT BE FULLY SCREWED IN CAUSING A 20 MINUTE DELAY TO THE SURGICAL PROCEDURE. THE SCREW WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRS-SCREW 24MM L X 3.0MM D 87HWC HWC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA