BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 3200025 · Received July 1, 2013

    Report

    Report Number
    1045834-2013-02624
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 7, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K002903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATES THIS WAS DUE TO USAGE WEAR OVER TIME. 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 THE ATTACHMENT DEVICE "OVERHEATED". THE PLANNED SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AS A SPARE IDENTICAL DEVICE WAS AVAILABLE FOR USE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. 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
    299914 11CM ANGLE ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)-ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1