BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM DIAMONHD BALL, 10CM

    MDR report key: 3984217 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-11817
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND IT WAS DETERMINED THAT THE ATTACHMENT HAD A WORN/DAMAGED BEARING IN THE DISTAL END. THE DAMAGED BEARING ALLOWED THE CUTTER SHAFT TO MAKE CONTACT THE MIDDLE SUB-ASSEMBLY OF THE ATTACHMENT, WHICH CAUSED IT TO SHEAR. BEARING DAMAGE IS OFTEN THE RESULT OF NORMAL WEAR OUT OVER TIME, BUT CAN BE EXACERBATED BY IMPROPER OR INEFFECTIVE CLEANING AND MAINTENANCE. (B)(4).

    Description of Event or Problem · 1

    REPORTER FROM THE U.S REPORTED THAT THE CUTTER BROKE DURING SURGERY AND WAS DIFFICULT TO REMOVE FROM THE DEVICE. THE REPRESENTATIVE WAS UNABLE TO RETRIEVE BEARING SLEEVE. THERE WERE NO REPORTS OF INJURY, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION HAD OCCURRED. THERE WAS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663850 3MM DIAMONHD BALL, 10CM HBE DEPUY SYNTHES POWER TOOLS E063045575

    Patients

    Seq Age Sex Outcome Treatment
    1 NI