BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 6977554 · Received October 18, 2017

    Report

    Report Number
    6977554
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 2, 2017
    Manufacturer
    REF # 03.037.022/ FIN # 200247579
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 6MM/ 9MM CANNULATED STEPPED DRILL BIT BROKE OFF IN THE PATIENT'S HIP DURING THE PROCEDURE. MEASURES WERE TAKEN TO REMOVE DRILL BIT PIECES FROM IMPACTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736798 SYNTHES STEPPED DRILL BIT LXH REF # 03.037.022/ FIN # 200247579 F-18258

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention