BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER MODULE F/TRS

    MDR report key: 3003772 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-00862
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS CONDUCTED AND IT STATES THAT THE NO FAILURE COULD BE DETECTED. THE DEVICE WAS OK AND THE MISTAKE COULD LIE IN THE HANDLE BAR. BASED ON THE ANALYSIS, A MANUFACTURING FAULT CAN BE RULED OUT. THE MANUFACTURING DOCUMENTS WHERE REVIEWED AS WELL. NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS. POWER MODULE DOES NOT FUNCTION. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106552 POWER MODULE F/TRS HWE SYNTHES GMBH SER.NR. 9551

    Patients

    Seq Age Sex Outcome Treatment
    1