BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3871835 · Received June 13, 2014

    Report

    Report Number
    8030965-2014-10296
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. VISUAL AND FUNCTIONAL ASSESSMENTS WERE PERFORMED AND THE DEVICE WAS FOUND TO HAVE DAMAGED BALL BEARINGS AND MOTOR ASSEMBLY. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO DEVICE COMPONENTS BEING WORN DUE TO NORMAL USE OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ULNAR OSTEOTOMY SURGERY, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE WAS CLICKING AND MAKING A GRINDING NOISE. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE AS A SPARE IDENTICAL DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO 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
    350474 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 003983

    Patients

    Seq Age Sex Outcome Treatment
    1