BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY ABG II STEM EXTRACTOR ASSEMBLY PER FILE H1769

    MDR report key: 2924551 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00109
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT AND THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SAME LOT NUMBER. A VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. A MATERIAL ANALYSIS REVIEW CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. THE INVESTIGATION CONCLUDED THAT THE DEVICE¿S FAILURE TO FUNCTION WAS CAUSED BY THE THREADED ROD GALLING WITHIN THE THREADED EXTRACTOR BODY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. THE REPORTED EVENT REGARDING THE GALLING OF A SPECIALTY ABGII STEM EXTRACTOR WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS REMOVING AN ABG STEM WITH INSTRUMENT, AND THE INSTRUMENT GOT STRIPPED AND BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS REMOVING AN ABG STEM WITH INSTRUMENT, AND THE INSTRUMENT GOT STRIPPED AND BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30684 SPECIALTY ABG II STEM EXTRACTOR ASSEMBLY PER FILE H1769 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F7S17026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other