BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 2982894 · Received February 28, 2013

    Report

    Report Number
    0001811755-2013-00402
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIN IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED BY THIRTY MINUTES BECAUSE THE SURGEON HAD TO REMOVE THE DISTAL TIP OF AN ORTHOLOCK EX-PIN 3X110 WHICH BROKE AND REMAINED IN THE PATIENT. THE BROKEN TIP WAS SUCCESSFULLY REMOVED; NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED BY THIRTY MINUTES BECAUSE THE SURGEON HAD TO REMOVE THE DISTAL TIP OF AN ORTHOLOCK EX-PIN 3X110 WHICH BROKE AND REMAINED IN THE PATIENT. THE BROKEN TIP WAS SUCCESSFULLY REMOVED; NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86473 ORTHOLOCK EX-PIN 3X110 STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO Z26563

    Patients

    Seq Age Sex Outcome Treatment
    1