BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2973692 · Received February 22, 2013

    Report

    Report Number
    8030965-2013-00593
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE RECEIVED FOR EVALUATION, DATE UNKNOWN. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WOULD NOT ENGAGE WHEN POWER WAS APPLIED DURING TESTING. THE UNIT EXHIBITED DAMAGE TO THE MOTOR AND ECU THAT WAS CONSISTENT WITH IMMERSION IN WATER. THIS CONDITION IS INDICATIVE OF IMPROPER CLEANING OF THE DEVICE. WE RECOMMEND THAT THE USER REVIEW THE CLEANING AND MAINTENANCE PROCEDURES FOR THE DEVICE. PROPER CLEANING AND MAINTENANCE ARE REQUIRED IN ORDER TO ENSURE TROUBLE-FREE OPERATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SHOULD BE EXEMPT: ENTERED IN ERROR.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A BATTERY DRIVE. IT WAS REPORTED THAT THE DEVICE WORKED INTERMITTENTLY EVEN WHEN NEW BATTERIES WERE INSTALLED. REPORTEDLY, THE DEVICE WAS NOT USED IN A SURGICAL PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM TO USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78487 SMALL BATTERY DRIVE SMALL BATTERY DRIVE HWE SYNTHES GMBH 004366

    Patients

    Seq Age Sex Outcome Treatment
    1