BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 3030792 · Received April 2, 2013

    Report

    Report Number
    0001811755-2013-00664
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE TIP OF THE PIN BROKE OFF WAS CONFIRMED THROUGH VISUAL INSPECTION. DURING THE INVESTIGATION NO SPECIFIC ROOT CAUSE COULD BE DETERMINED FOR THE PIN BREAKAGE. THE PIN IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THE TIP OF THE BROKEN PINS REMAIN IMPLANTED BUT THE BROKEN PIECE HAS NOT BEEN RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED. NO RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DRILLING OF ORTHOLOCK TIBIAL PINS INTO THE PATIENT'S TIBIA, THREE PINS BROKE OFF AT THE TIP CONSECUTIVELY. THE PINS REMAINED IMPLANTED IN THE PATIENT. FEMORAL PINS WERE USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DRILLING OF ORTHOLOCK TIBIAL PINS INTO THE PATIENT'S TIBIA, THREE PINS BROKE OFF AT THE TIP CONSECUTIVELY. THE PINS REMAINED IMPLANTED IN THE PATIENT. FEMORAL PINS WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134319 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO Z27756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other