BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40MM/4MM ANCHORING PIN

    MDR report key: 3110580 · Received May 14, 2013

    Report

    Report Number
    0001811755-2013-01103
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 40MM/4MM ANCHORING PIN BROKE DURING A TOTAL KNEE ATHROPLASTY. THE BROKEN PIN WAS SUCCESSFULLY RETRIEVED AND AN ALTERNATE PIN WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO ADVERSE CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 40MM/4MM ANCHORING PIN BROKE DURING A TOTAL KNEE ARTHROPLASTY. THE BROKEN PIN WAS SUCCESSFULLY RETRIEVED AND AN ALTERNATE PIN WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212286 40MM/4MM ANCHORING PIN STEREOTAXIC HAW STRYKER INSTRUMENTS-KALAMAZOO 0125

    Patients

    Seq Age Sex Outcome Treatment
    1