BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER MODULE F/TRS

    MDR report key: 2955632 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00379
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT A POWER TOOL AND BATTERY FOR THE TRAUMA RECON SYSTEM WOULD NOT TURN OFF UNTIL BATTERY WAS REMOVED. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58258 POWER MODULE F/TRS POWER MODULE HWE SYNTHES GMBH SER.-NR. 7505

    Patients

    Seq Age Sex Outcome Treatment
    1