BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LID F/BATT-HANDPIECE NO. 05.001.201 F/TR

    MDR report key: 3202982 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04246
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE NEW TRS HANDPIECE RECEIVED DOES NOT FIT EXACTLY TO THE LID. DEVICE HAS JAMMED THE GLOVE DURING CLOSING. THE HANDPIECE IS SLIGHTLY OVAL IN SHAPE. REPORTEDLY, THIS HANDPIECE WAS COMPARED WITH AN OLDER HANDPIECE AND A DIFFERENCE WAS SEEN. REPORTEDLY, THE DEVICE MAY BE UNSTERILE INTRAOPERATIVELY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302933 LID F/BATT-HANDPIECE NO. 05.001.201 F/TR MOQ SYNTHES GMBH SER.NR. 6387

    Patients

    Seq Age Sex Outcome Treatment
    1