BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM CRSE DMND MTCHSTCK,15CM

    MDR report key: 4182749 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14641
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CONTACT PHONE NUMBER PROVIDED. THE LOT NUMBER OF DEVICE WAS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURING WAS UNKNOWN. THE REPORTER STATED THAT THE DEVICE WILL NOT BE 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

    REPORT 4 OF 6 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING A CERVICAL SPINAL SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHEN THE SURGEON WAS USING THE ATTACHMENT DEVICE, THE END OF THE CUTTER BROKE AFTER 5 MINUTES OF USING TIME. THE REPORTER INDICATED THAT THE RESIDUAL PART OF THE CUTTER WAS STUCK IN THE ATTACHMENT DEVICE. ACCORDING TO THE REPORTER, THE DEVICE WAS BRAND NEW. THE REPORTER INDICATED THAT THE EVENT OCCURRED 5 TIMES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY 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
    660346 3MM CRSE DMND MTCHSTCK,15CM DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR HBE DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT DEVICE