BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE 2.7-4.0MM

    MDR report key: 1022126 · Received March 26, 2008

    Report

    Report Number
    1818910-2008-00805
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE INSTRUMENT CAME APART AND WAS READING 12MM TOO LONG. THIS CAUSED A 45 MIN DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH GAUGE 2.7-4.0MM 87LXH LXH DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR