BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAMER-9MM

    MDR report key: 22738 · Received June 9, 1995

    Report

    Report Number
    22738
    Event Type
    Injury
    Date Received
    June 9, 1995
    Date of Event
    May 29, 1995
    Report Date
    June 8, 1995
    Manufacturer
    SYNTHES INC.
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTERMEDULLARY REAMER LODGED IN CANAL. REVERSE REAMING CREATED HEAT AT ANKLE. REAMER REMOVED. COLD NORMAL SALINE TO CANAL. QUARTER SIZED BLISTER NOTED TO ANKLE WHILE PT IN POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAMER-9MM REAMER-9MM HTO SYNTHES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention