BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3922156 · Received July 9, 2014

    Report

    Report Number
    8030965-2014-10377
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. THEREFORE, 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 A LIGAMENT RECONSTRUCTION AND TENDON INTERPOSITION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE WAS LOSING POWER AND WORKING INTERMITTENTLY. AS A RESULT, THERE WAS A TEN MINUTE DELAY TO THE SURGICAL PROCEDURE. ACCORDING TO THE REPORT, A SPARE BATTERY DEVICE WAS AVAILABLE FOR USE. THE REPORTER STATED THAT THERE WAS ENOUGH POWER FOR THE SURGEON TO SUCCESSFULLY FINISH THE SURGICAL PROCEDURE WITH THE SPARE BATTERY DEVICE. HOWEVER, THE DEVICE STOPPED WORKING ALTOGETHER AFTER THE PROCEDURE WAS COMPLETED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. AFTER THE PROCEDURE, THE SMALL BATTERY DRIVE DEVICE WAS TESTED WITH ANOTHER BATTERY DEVICE AND IT WAS OBSERVED THAT THE DEVICE STILL HAD NO POWER. 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
    401262 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 00596

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR BATTERY DEVICE