BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3241178 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04465
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED ON 22-MAR-2013 FOR ROUTINE MAINTENANCE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE CUSTOMERS COMPLAINT THAT THIS DEVICE HAS A STICKY TRIGGER WAS CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE TRIGGER IS STICKING. THIS IS DUE TO IMPROPER CLEANING.

    Description of Event or Problem · 1

    FACILITY REPORTS THE TRIGGER ON THE SMALL BATTERY DRIVE IS STICKING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340569 SMALL BATTERY DRIVE HWE SYNTHES GMBH 003627

    Patients

    Seq Age Sex Outcome Treatment
    1