BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 2061256 · Received April 12, 2011

    Report

    Report Number
    1719045-2011-00177
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING AN IM RODDING OF NAIL THE SURGEON WAS USING THE STANDARD INSERTION HANDLE TO INSERT THE NAIL. SURGEON USED SOME FORCE TO INSERT THE NAIL AND THE SMALL SQUARE ATTACHMENT ON THE HANDLE BROKE. SURGEON DID NOT SEE THE PIECE IN THE PATIENT, IT REMAINS UNKNOWN WHERE THE PIECE WENT. NO X-RAYS WERE TAKEN TO CONFIRM IT WAS NOT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD INSERTION HANDLE INSERTION HANDLE LXH SYNTHES MONUMENT NA 4819614

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention NAIL