BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 12V BATTERY

    MDR report key: 5306766 · Received December 17, 2015

    Report

    Report Number
    8030965-2015-12355
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 7, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE LOT NUMBER WAS INADVERTENTLY ENTERED AS SERIAL NUMBER ON THE INITIAL REPORT. THE LOT NUMBER WAS UPDATED AS D150819 AND THE SERIAL NUMBER AS NA. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. (B)(4) EVALUATED THE DEVICE AND OBSERVED THAT THE BATTERY COULD NOT CHARGE BECAUSE THE CONTACTS WERE NOT WELDED PROPERLY. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO FAULTY PRODUCTION. 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 FROM (B)(6) THAT BEFORE SURGERY, IT WAS OBSERVED THAT THE BATTERY DEVICE WAS NOT CHARGING. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    835074 SMALL BATTERY DRIVE 12V BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF D150819

    Patients

    Seq Age Sex Outcome Treatment
    1