BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 4033016 · Received August 25, 2014

    Report

    Report Number
    1045834-2014-12643
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    August 5, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    \THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. (B)(4) EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE MET ALL MANUFACTURE'S SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 DURING AN EAR ATRESIA SURGERY, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS OVERHEATING. THE REPORTER ALSO STATED THAT THE BURR SEEMED LOOSE. THERE WAS A ONE TO TWO MINUTES DELAY TO THE SURGICAL PROCEDURE TO SET-UP THE SPARE IDENTICAL DEVICE. THE REPORTER STATED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE SPARE IDENTICAL DEVICE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF THE EVENT WAS UNKNOWN. 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
    514330 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTING BURR DEVICE