BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY 4.0 X 60MM THREADED

    MDR report key: 1823257 · Received August 30, 2010

    Report

    Report Number
    2249697-2010-01159
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2010-01160.

    Description of Event or Problem · 1

    PROF. WAS DRILLING WITH A 60 MM DRILL BIT THROUGH THE CLUSTER SHELL INTO THE ACETABULUM WHEN HE SAID THAT THE DRILL BIT HAD BROKEN. HE WAS ABLE TO REMOVE THE BROKEN PIECE FROM THE PATIENT. HE THEN TRIED DRILLING AGAIN WITH A 40 MM DRILL BIT AND WHEN RETURNED TO THE NURSE, IT WAS OBSERVED THAT IT WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY 4.0 X 60MM THREADED INSTRUMENT HTW STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention