BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIAL PIN INSERTER/EXTRACTOR

    MDR report key: 9633778 · Received January 27, 2020

    Report

    Report Number
    3013450937-2020-00007
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    December 19, 2019
    Report Date
    October 5, 2020
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRP
    UDI-DI
    B27825102211E0
    PMA / PMN Number
    K161520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THAT THE COMPONENT INVOLVED MET SPECIFICATION. THE DAMAGED INSTRUMENT WAS RETURNED FOR FURTHER ANALYSIS AND IT WAS CONFIRMED THAT THE THREADS HAD CROSS THREADED. INTERVIEW WITH THE SALES REPRESENTATIVE FOUND THAT THE SURGEON ATTEMPTED TO KEEP THE INCISION VERY MINIMAL, WHICH DID NOT GRANT THEM EASY TRAJECTORY FOR THE INSTRUMENT. THE SALES REPRESENTATIVE REPORTED THAT THE INSTRUMENT HAD BEEN INSERTED INTO THE PIN ON AN ANGLE, THUS CAUSING THE THREADS TO CROSS AND THE INSTRUMENT TO BECOME DAMAGED. ADDITIONALLY, THIS INSTRUMENT IS REUSABLE, AND ITS LIFE SPAN DEPENDS ON THE METHOD IN WHICH IT IS USED, THE DURATION OF USE, AND ITS HANDLING BETWEEN USES. ULTIMATELY, BASED UPON THE DEVICE HISTORY RECORD AND INTERVIEW WITH THE SALES REPRESENTATIVE IT WAS CONCLUDED THAT THE INSTRUMENT FAILURE COULD NOT BE ATTRIBUTED TO THE MANUFACTURING OF THE ELEOS COMPONENT.

    Description of Event or Problem · 0

    THE AXIAL PIN INSERTER/EXTRACTOR CROSS THREADED WITH AN AXIAL PIN AND BECAME DAMAGED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THAT THE COMPONENT INVOLVED MET SPECIFICATION. THE DAMAGED INSTRUMENT WAS REQUESTED TO BE RETURNED FOR FURTHER ANALYSIS. SHOULD ADDITIONAL INFORMATION BE OBTAINED THE REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE AXIAL PIN INSERTER/EXTRACTOR CROSS THREADED WITH AN AXIAL PIN AND BECAME DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97534 AXIAL PIN INSERTER/EXTRACTOR PROSTHESIS, KNEE KRP ONKOS SURGICAL 25102211E 1488408 B27825102211E0

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR