BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2MM FLUTED BALL, EXT

    MDR report key: 3123995 · Received May 22, 2013

    Report

    Report Number
    1045834-2013-02166
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE DEVICE MET MANUFACTURE SPECIFICATIONS THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) REGARDING A CUTTER/BURR DEVICE IN WHICH THE DOCTOR STATED THAT THE DEVICE WAS NOT "CUTTING CORRECTLY". ACCORDING TO THE REPORT, THE DOCTOR STATED THAT THE CUTTER/BURR DEVICE HAD A "FLAT EDGE INSTEAD OF A SHARP CUTTING EDGE" AND THAT THE DEVICE WAS "POLISHING INSTEAD OF CUTTING". THE ALLEGED DEFECT WAS OBSERVED DURING A COCHLEAR IMPLANT PROCEDURE. AS A RESULT, THERE WAS A THIRTY SECOND DELAY WHILE SWITCHING TO AN UNKNOWN SPARE CUTTER/BURR DEVICE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225889 2MM FLUTED BALL, EXT MOTOR, DRILL, ELECTRIC- HBC DEPUY SYNTHES POWER TOOLS F446011109

    Patients

    Seq Age Sex Outcome Treatment
    1