BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3970062 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-14768
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    July 14, 2011
    Report Date
    July 18, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "OVERHEATING" WAS CONFIRMED. DURING SERVICE, THE DEVICE FAILED THE TEMPERATURE TEST. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE EXPERIENCED OVERHEATING DURING SURGERY. NO INJURY OCCURRED. IT IS UNKNOWN IF SURGICAL DELAY OR MEDICAL INTERVENTION OCCURRED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648335 5.0CM SHORT ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1