BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK POINT PIN

    MDR report key: 9994143 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00121
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    January 18, 2014
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10. H3, H6: THE DEVICE, INTENDED TO BE USED DURING TREATMENT, WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION OF RETURNED PHOTO CONFIRMED THAT THE CHECKPOINT PIN WAS BROKEN. THEREFORE, THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND FOUND SIMILAR REPORTS OF THE REPORTED PRODUCT PROBLEM. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED ISSUE WAS ESTABLISHED. THE CHECKPOINT PIN BREAKAGE DUE TO MECHANICAL COMPONENT FAILURE. FUNCTIONAL INVESTIGATION WAS PERFORMED ON TP0440 (THE CHECKPOINT ENGINEERING TEST PROTOCOL) AND TR0440 (LANDMARK VERIFICATION POINTS ENGINEERING TEST RESULTS) FOR AN EQUIVALENT DEVICE AND PART NUMBER (PN 100879), AND NOT THE SUBJECT DEVICE OF THE COMPLAINT THAT OCCURRED ON 01/18/2014. IT WAS FOUND THAT THE CHECKPOINTS ARE NOT DURABLE ENOUGH AND MAY BE SUSCEPTIBLE TO FATIGUE FAILURE, ESPECIALLY ON REPEATED USE ON PATIENTS WITH DENSE BONES. A FACTOR THAT MAY CAUSE THIS IS IF THE USER EMPLOYS A PRYING ACTION WITH THE WRENCH TO REMOVE THE CHECKPOINT PIN, ESPECIALLY IF THE USER PULLS THE PIN OUT LINEARLY A FEW MILLIMETERS THEN USES A PRYING ACTION, IT EMPLOYS GREATER STRESS ON THE WEAKEST POINT OF THE CHECKPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CADAVER LAB WITH A SURGEON, THE CHECKPOINT PIN BROKE OFF IN THE TIBIA OF THE SPECIMEN. THE REP HAD TO DIG INTO THE BONE TO RECOVER THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458708 CHECK POINT PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1