BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCLWIRE Ø1 W/EYE L600 SST

    MDR report key: 2889121 · Received December 28, 2012

    Report

    Report Number
    8030965-2012-01694
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LRN
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION SHOWS THAT THERE ARE REALLY DIAMETERS 1.5MM INSTEAD OF 1.0MM INSIDE THE PACKAGES. ONE CYCLE DURING MANUFACTURING PROCESS WAS NOT CARRIED OUT AS INTENDED. REGARDLESS OF CORRECT AND DOCUMENTED EXISTING CHECKING PROCEDURE THIS CONDITION WAS NOT DETECTED BY HUMAN ERROR. ACCORDING TO OUR RESEARCH, NO OTHER ITEMS/LOT NUMBERS ARE AFFECTED BY THIS CONFUSION. DELIVERY STOP WAS INTRODUCED TO BLOCK ALL ARTICLES OF THE LOT IN QUESTIONS. A CAPA HAS BEEN INITIALED WITH ALL ITEMS DOCUMENTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: UPON RECEIPT OF THE DEVICE, THE ACCOUNT NOTED THAT THE DIAMETER OF THE WIRE SHOULD BE 1MM BUT IT IS 1.5MM. LABEL ON THE DEVICE NOTES THAT THE DIAMETER OF THE CERCLAGE WIRE IS 1MM BUT THE DIAMETER OF THE PACKAGED WIRE IS 1.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERCLWIRE Ø1 W/EYE L600 SST CERCLAGE WIRE LRN SYNTHES GMBH 8100310

    Patients

    Seq Age Sex Outcome Treatment
    1