BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRS-SCREW 24MM L X 3.0MM D

    MDR report key: 967073 · Received December 13, 2007

    Report

    Report Number
    1818910-2007-04064
    Event Type
    Other
    Date Received
    December 13, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 13, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K062352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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

    TIP OF SCREW BROKE OFF WHEN DOCTOR WAS FIXATING OSTEOTOMY SITE, RESULTING IN A ONE (1) HOUR EXTENSION OF SURGICAL TIME.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male NA.