BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CUTTER DEVICE

    MDR report key: 3926527 · Received July 10, 2014

    Report

    Report Number
    1045834-2014-12466
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE CATALOG AND LOT NUMBERS OF THE DEVICE ARE UNKNOWN THE COMMON DEVICE NAME, DEVICE PRODUCT CODE, AND PMA/510K NUMBERS ARE UNKNOWN. THE CATALOG NUMBER AND LOT ARE UNKNOWN. THEREFORE, DEVICE MANUFACTURE DATE IS UNKNOWN. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED THAT THE BURR WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING A MASTOIDECTOMY SURGERY, IT WAS OBSERVED THAT THE CUTTER DEVICE AND ATTACHMENT DEVICE HEATED UP DURING USE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND A SPARE ATTACHMENT DEVICE WAS AVAILABLE FOR USE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SPARE DEVICE. THE REPORTER STATED THAT IRRIGATION WAS NOT USED AS A RESULT OF THE REPORTED MALFUNCTION. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403013 UNKNOWN CUTTER DEVICE NI HBC DEPUY SYNTHES POWER TOOLS N/I

    Patients

    Seq Age Sex Outcome Treatment
    1