BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 3202483 · Received July 2, 2013

    Report

    Report Number
    1045834-2013-02645
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE SURGERY, IT WAS OBSERVED THAT THE BURR/CUTTER DEVICE WOULD "NOT INSERT INTO THE CURVE SLEEVE" OF THE ATTACHMENT DEVICE. ACCORDING TO THE REPORTER, THE USER ATTEMPTED TO INSERT A SECOND BURR/CUTTER DEVICE. IT WAS OBSERVED THAT THE SECOND BURR/CUTTER DEVICE WOULD "NOT INSERT INTO THE CURVE SLEEVE" OF THE ATTACHMENT DEVICE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS UNKNOWN TO THE REPORTER IF A SPARE DEVICE WAS AVAILABLE.  THE REPORTER CONFIRMED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. NO INJURIES OR MEDICAL INTERVENTION WERE 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
    301326 MINIMAL ACCESS ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)- ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BURR/CUTTER DEVICE