BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ATTACHMENT-MEDIUM FOR PEN DRIVE

    MDR report key: 4181080 · Received October 17, 2014

    Report

    Report Number
    2520274-2014-14214
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A DOUBLE JAW SURGICAL PROCEDURE, IT WAS OBSERVED THAT IT WAS DIFFICULT TO LOAD THE BURR DEVICE INTO THE ATTACHMENT DEVICE. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO KEEP THE BURR DEVICE LOCKED IN POSITION. THERE WAS A THREE MINUTE DELAY TO THE SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS OBSERVED THAT THE SPARE DEVICE EXPERIENCED THE SAME ISSUE. A SECOND SPARE SYSTEM WAS AVAILABLE FOR USE AND WAS USED TO COMPLETE THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    661685 BURR ATTACHMENT-MEDIUM FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 1989786

    Patients

    Seq Age Sex Outcome Treatment
    1 BURR DEVICE