BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCANAIL

    MDR report key: 12131413 · Received July 7, 2021

    Report

    Report Number
    3003898228-2021-00003
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 9, 2021
    Report Date
    September 14, 2021
    Manufacturer
    FH INDUSTRIE
    Product Code
    HSB
    UDI-DI
    03661489670565
    PMA / PMN Number
    K150463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    SURGEON GUIDED 12MM REAMER OVER OLIVE GUIDE WIRE AND UPON EXPERTING PRESSURE WHILE DRILLING INTO THE CALCANEUS WE HEARD A CRACK. ON VIEWING ON X-RAY WE COULD SEE THAT THE BASE ON THE 12MM REAMER HAD SPANNED. SURGEON THAN REMOVED THE DRILL FROM REAMER ATTACHMENT AND PROCEEDED TO PULL REAMER OUT WITH WRENCH AND MALLET.

    Description of Event or Problem · 0

    SURGEON GUIDED 12MM REAMER OVER OLIVE GUIDE WIRE AND UPON EXPERTING PRESSURE WHILE DRILLING INTO THE CALCANEUS WE HEARD A CRACK. ON VIEWING ON X-RAY WE COULD SEE THAT THE BASE ON THE 12MM REAMER HAD SPANNED. SURGEON THAN REMOVED THE DRILL FROM REAMER ATTACHMENT AND PROCEEDED TO PULL REAMER OUT WITH WRENCH AND MALLET.

    Description of Event or Problem · 1

    SURGEON GUIDED 12MM REAMER OVER OLIVE GUIDE WIRE AND UPON EXERTING PRESSURE WHILE DRILLING INTO THE CALCANEUS WE HEARD A CRACK. ON VIEWING ON X-RAY WE COULD SEE THAT THE BASE ON THE 12MM REAMER HAD SPANNED. SURGEON THAN REMOVED THE DRILL FROM REAMER ATTACHMENT AND PROCEEDED TO PULL REAMER OUT WITH WRENCH AND MALLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027312 CALCANAIL CALCANAIL AO LARGE THREADED TREPHINE D12 L140 HSB FH INDUSTRIE 267056 03661489670565

    Patients

    Seq Age Sex Outcome Treatment
    1