BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOGRAPHIC RULER

    MDR report key: 1883365 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06561
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    SURGEON USED THE RADIOGRAPHIC RULER AND TOOK A DIRECT MEASUREMENT FROM C-ARM TO DETERMINE THE LENGTH OF LONG TROCH NAIL TO USE. THE RADIOGRAPHIC RULER MEASURED 34CM. UPON INSERTION OF THE NAIL, SURGEON STATED THAT THE MEASUREMENT FROM THE RULER WAS OFF BY 2CM. THE NAIL WAS REMOVED AND REPLACED WITH A 36CM NAIL. THE CASE WAS DELAYED APPROX 30 MINUTES AS A RESULT OF THE READING TAKEN OFF THE RULER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOGRAPHIC RULER 87LXH LXH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA Z4KB24

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention