BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX-WRIST

    MDR report key: 56141 · Received December 12, 1996

    Report

    Report Number
    2242546-1996-00104
    Event Type
    Malfunction
    Date Received
    December 12, 1996
    Date of Event
    December 3, 1996
    Report Date
    December 11, 1996
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE TO APPLY A DFS DISTAL RADIUS FIXATOR, THE DRILL BIT BROKE OFF IN THE PT'S BONE. THE DRILL BIT PIECE WAS LEFT IN THE PT'S BONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DRILL BIT WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX-WRIST Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. 05016 413240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other