BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM BALL IMPACTOR TIP

    MDR report key: 3693164 · Received March 21, 2014

    Report

    Report Number
    0002249697-2014-00870
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING AN ADM IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED FRACTURE OCCURRED IN MULTIPLE OVERLOADS, FRACTURING FROM THE INSIDE DIAMETER OUT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THIS EVENT WAS PREVIOUSLY INVESTIGATED AND IS CURRENTLY UNDER A CAPA INVESTIGATION. IT WAS DETERMINED THAT THERE IS A DESIGN ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING MDM SURGERY, WHEN A SURGEON WAS IMPACTED MDM LINER WITH THE REPORTED DEVICE, IT BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING MDM SURGERY, WHEN A SURGEON WAS IMPACTED MDM LINER WITH THE REPORTED DEVICE, IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169704 ADM BALL IMPACTOR TIP INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3654009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other