BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE

    MDR report key: 9993726 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00374
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    September 13, 2017
    Report Date
    April 23, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE FIELD REPORT NOTED THAT SIX BONE PINS WERE BENT. THE OTHER BONE PINS WERE INVESTIGATED UNDER 17-0271-2, 17-0271-3, 17-0271-4, 17-0271-5, AND 17-0271-6. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW IDENTIFIED 22 PRIOR SIMILAR EVENTS. WE WERE NOT ABLE TO CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE AND THE ROOT CAUSE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE THE USER ALLOWING THE WEIGHT OF THE DRILL TO FALL AS IT IS ATTACHED TO THE PIN, IF THE BONE PIN IS HELD RIGIDLY IN PLACE DURING REMOVAL, OR IF THE PATIENT'S BONE IS HARDER THAN NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BONE PIN OF THE NAVIO TRAY WAS FOUND BENT DURING STERILIZATION. NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455055 SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1