BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4MM EXTRA COARSE DIAMOND BALL

    MDR report key: 3232085 · Received July 17, 2013

    Report

    Report Number
    1045834-2013-03575
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 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

    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).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THE ALLEGED MALFUNCTION OCCURRED DURING SET-UP FOR A COCHLEAR IMPLANT SURGERY. THE REPORTER STATED THAT THE PATIENT WAS BEING ANESTHETIZED. THERE WERE NO DELAYS TO THE SCHEDULED PROCEDURE AS A SPARE DEVICE WAS AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SPARE DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT IT WAS OBSERVED THAT THE CUTTER/BURR DEVICE WOULD NOT "FIT" INTO THE ATTACHMENT DEVICE. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY.  IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE.  IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED.  SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332495 4MM EXTRA COARSE DIAMOND BALL MOTOR, DRILL, ELECTRIC- CUTTER HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT DEVICE