BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM SHAFT HAMMER SLIDE

    MDR report key: 468487 · Received June 27, 2003

    Report

    Report Number
    1818910-2003-00377
    Event Type
    Injury
    Date Received
    June 27, 2003
    Date of Event
    May 28, 2003
    Report Date
    May 28, 2003
    Manufacturer
    DEPUY-RAYNHAM, INC.
    Product Code
    GFJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT BROKEN AT WELD. SURGERY WAS DELAYED FOR 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM SHAFT HAMMER SLIDE MANUAL SURGICAL INSTRUMENT GFJ DEPUY-RAYNHAM, INC. NA V0696

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention