BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFT FILTER FOR RIA-STERILE

    MDR report key: 1933194 · Received December 14, 2010

    Report

    Report Number
    1719045-2010-00362
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NEITHER IMPLANTED NOR EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW WILL BE REQUESTED.

    Description of Event or Problem · 1

    DURING A HIND FOOT FUSION SURGEON WAS REAMING THE RIGHT TIBIA WITH A 12MM REAMER HEAD FOR GRAFT MATERIAL. THE (B)(6) NEEDED TO BE TIGHTENED A FEW TIMES AND THE SURGEON LEFT THE SUCTION ON. SURGEON DISCOVERED THAT NO GRAFT MATERIAL WENT INTO THE FILTER. SURGEON SELECTED ANOTHER FILTER AND USED A LARGER 12.5MM REAMER HEAD FOR ADDITIONAL REAMING OF THE RIGHT TIBIA. SURGEON COLLECTED ONLY 10CC OF GRAFT MATERIAL AND USED ADDITIONAL GRAFT FROM A PACKAGED SOURCE. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFT FILTER FOR RIA-STERILE GRAFT FILTER HTO SYNTHES MONUMENT NA 6452136

    Patients

    Seq Age Sex Outcome Treatment
    1 NI REAMER HEAD