BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IM ALIGN GUIDE FEM

    MDR report key: 345638 · Received August 7, 2001

    Report

    Report Number
    1818910-2001-00251
    Event Type
    Injury
    Date Received
    August 7, 2001
    Date of Event
    June 14, 2001
    Report Date
    August 7, 2001
    Manufacturer
    DEPUY-NEW BEDFORD/DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    FZX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE WING NUT THAT ATTACHES THE GUIDE TO THE RESECTION BLOCK WOULD NOT DISENGAGE. THE DR TRIED TO USE AN OSTEOTOME TO FORCE IT TO TURN AND PUNCTURED DR'S FINGER; REQUIRING A STITCH TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35609 IM ALIGN GUIDE FEM MANUAL ORTHOPAEDIC INSTRUMENT FZX DEPUY-NEW BEDFORD/DIV OF DEPUY ORTHOPAEDICS, INC. NA 1/92

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention