BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 1456531 · Received June 18, 2009

    Report

    Report Number
    1719045-2009-00115
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 1, 2009
    Report Date
    June 17, 2009
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. H3, H6: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURER DATE CAN NOT BE DETERMINED WITHOUT A LOT NUMBER. THE COMPLAINT HANDLING UNIT (CHU) RECEIVED INFO FROM THE SALES CONSULTANT ON JUNE 17, 2009 STATING THE INCIDENT OCCURRED ON (B) (6) 2009. THE CHU IS SUBSEQUENTLY SUBMITTING THIS 30 DAYS NOTIFICATION ON THE INFO RECEIVED ON JUNE 17, 2009.

    Description of Event or Problem · 1

    DURING AN IM NAILING ON A YOUNG MALE PT WITH AN EXTREMELY SMALL MEDULLARY CANAL, THE REAMER HEAD BROKE AND ONE OR TWO DEVICE FRAGMENTS WERE NOT REMOVED. THE NAIL COULD NOT BE PLACED DUE TO THE SMALL CANAL AND THE SURGEON REPORTEDLY USED A BONE GRAFT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD MEDULLARY REAMER HEAD - 8.5MM DIAMETER HTO SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI REAMER