BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3130616 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02809
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPORTS DURING AN ORTHOPEDIC PROCEDURE ON (B)(4) 2013, THE SMALL BATTERY DRIVE QUIT WORKING. BATTERIES WERE CHANGED AND THE DEVICE WAS CLEANED, BUT DEVICE STILL DID NOT FUNCTION. IT IS REPORTED THE PROCEDURE WAS DELAYED APPROXIMATELY 2 MINUTES. A LARGE BATTERY DRIVE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231739 SMALL BATTERY DRIVE HWE SYNTHES USA 002835

    Patients

    Seq Age Sex Outcome Treatment
    1