BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12421005 · Received September 3, 2021

    Report

    Report Number
    12421005
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    May 12, 2021
    Report Date
    August 20, 2021
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STRYKER DRILL BIT BROKE AND WITHIN THE BODY OF THE MEDIAL CALCANEOUS DURING THE PROCEDURE. THE DRILL BIT WAS NOTED TO BE WITHIN THE SUBSTANCE OF THE BONE AND WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320540 NA INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER TRAUMA SA LOT NUMBER: K07AA83.

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA