BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED OSTEOTOME

    MDR report key: 2481389 · Received March 1, 2012

    Report

    Report Number
    MW5024524
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 1, 2012
    Product Code
    HWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CURVED OSTEOTOME BROKE OFF AT THE TIP. COUPLE PIECES OF METAL WERE PULLED OUT. PHYSICIAN FELT THAT THEY GOT ALL OF IT. PT WAS HAVING A LEFT TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED OSTEOTOME NONE HWM SSI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR