BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PEDICLE FEELER

    MDR report key: 3192781 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01484
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K012380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT THAT THE TIP WAS BROKEN OFF WAS CONFIRMED THROUGH THE VISUAL INSPECTION. DURING THE DEVICE EVALUATION WE WERE UNABLE TO DETERMINE WHAT CAUSED THE BROKEN TIP. IT IS POSSIBLE ROUGH OR IMPROPER HANDLING LED TO THE BROKEN TIP. THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.

    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. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT THE USER FACILITY, THE TIP OF THE PEDICLE FEELER BROKE OFF WHILE THE FEELER WAS USED IN THE SPINE TO CREATE A PATH THROUGH THE PEDICLE. IT WAS REPORTED THAT BROKEN PIECE WAS LOCATED AND SUCCESSFULLY REMOVED WITHOUT ANY HARM. A BACK-UP PEDICLE FEELER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT THE USER FACILITY, THE TIP OF THE PEDICLE FEELER BROKE OFF WHILE THE FEELER WAS USED IN THE SPINE TO CREATE A PATH THROUGH THE PEDICLE. IT WAS REPORTED THAT BROKEN PIECE WAS LOCATED AND SUCCESSFULLY REMOVED WITHOUT ANY HARM. A BACK-UP PEDICLE FEELER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291919 THORACIC PEDICLE FEELER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1