BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3812323 · Received May 15, 2014

    Report

    Report Number
    8030965-2014-10233
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 18, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 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

    THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED THAT DURING A SMALL BONE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE POWER WAS ¿CUTTING IN AND OUT¿ ON THE ELECTRIC PEN DRIVE DEVICE AND THE CABLE DEVICE. THERE WERE NO DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS A SPARE SET OF DEVICES WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF PATIENT OR USER INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN, HOWEVER, THE REPORTER CLARIFIED THAT THE EVENT OCCURRED IN (B)(6) 2014. 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
    291766 ELECTRIC PEN DRIVE 60,000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 3366

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE DEVICE