BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 4132373 · Received October 1, 2014

    Report

    Report Number
    1045834-2014-12959
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE FAILED THE CUTTER INSERTION ASSESSMENT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THIS WAS DUE TO THE BEARINGS BEING OUT OF AXIAL ALIGNMENT. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR AND SERVICING OVER TIME. 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

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE WOULD NOT SPIN THE BURR. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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
    612705 MINIMAL ACCESS ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BURR DEVICE