BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM SHORT ANGLE ATTACH

    MDR report key: 3181501 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02500
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K002903
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 COCHLEAR SURGERY THE DRILL BIT WOULD NOT GO INTO THE ATTACHMENT DEVICE. AN ATTEMPT WAS MADE WITH A DIFFERENT DRILL BIT, BUT WAS UNSUCCESSFUL. THE REPORTER CONFIRMED THAT THERE WAS NO DELAY IN SURGERY; AN IDENTICAL SPARE DEVICE WAS AVAILABLE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE REPORTER ALSO CONFIRMED THAT THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282156 7.5CM SHORT ANGLE ATTACH DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)-ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1