BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM FLUTED MATCHSTICK

    MDR report key: 3983740 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14252
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 30, 2011
    Report Date
    November 30, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE CONDITION WAS CONFIRMED. THE CUTTER DEVICE WAS RECEIVED STUCK INSIDE THE ATTACHMENT AND HAD DISCOLORATION ALONG THE SHAFT, INDICATIVE OF EXCESSIVE HEAT. THE ATTACHMENT SHOWED DAMAGE SUCH THAT IT SHOULD NOT HAVE BEEN USED WITH ANY CUTTER. THE CAUSE WAS DETERMINED TO BE USAGE WITH A DAMAGED ATTACHMENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM THE USA STATING THAT THE DEVICE WAS OVERHEATING. REPORTEDLY THE DEVICE BECAME HOT ENOUGH TO CHAR BLOOD ON THE CUTTING BURR AND ATTACHMENT DEVICE. IT IS KNOWN THAT THE DEVICE WAS BEING USED DURING SURGERY. IT IS KNOWN THAT THERE WERE NO INJURIES OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664401 3MM FLUTED MATCHSTICK HBC DEPUY SYNTHES POWER TOOLS E403055606

    Patients

    Seq Age Sex Outcome Treatment
    1