BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 3192123 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01470
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE PIN BROKE OFF WAS CONFIRMED THROUGH VISUAL INSPECTION. DURING INVESTIGATION NO SPECIFIC ROOT CAUSE COULD BE DETERMINED FOR THE PIN BREAKAGE. BASED ON ADDITIONAL INFORMATION PROVIDED DURING THE FOLLOW UP REPORT IT IS POSSIBLE THAT TRANSLATIONAL OR BENDING FORCES CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS THE DOCTOR PUTS A SLIGHT TORQUE ON THE PIN BECAUSE HE DRILLS THE PINS IN REACHING OVER THE LEG.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. DEVICE NOT RETURNED FOR EVALUATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE UPDATED LOT NUMBER WAS REPORTED UPON RECEIPT OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON THE RIGHT KNEE AT THE USER FACILITY, THE PIN BROKE WHILE BEING PLACED IN THE TIBIA AND A FRAGMENT HAD TO BE LEFT IN THE BONE. IT WAS REPORTED THAT THE SURGEON USED ANOTHER PIN TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY AND WITHOUT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON THE RIGHT KNEE AT THE USER FACILITY, THE PIN BROKE WHILE BEING PLACED IN THE TIBIA AND A FRAGMENT HAD TO BE LEFT IN THE BONE. IT WAS REPORTED THAT THE SURGEON USED ANOTHER PIN TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY AND WITHOUT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON THE RIGHT KNEE AT THE USER FACILITY, THE PIN BROKE WHILE BEING PLACED IN THE TIBIA AND A FRAGMENT HAD TO BE LEFT IN THE BONE. IT WAS REPORTED THAT THE SURGEON USED ANOTHER PIN TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY AND WITHOUT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292038 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO Z25393

    Patients

    Seq Age Sex Outcome Treatment
    1