BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT 2.4 MM

    MDR report key: 11798494 · Received May 10, 2021

    Report

    Report Number
    1220246-2021-03028
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867004528
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-1204F-24I, BATCH 012035 INSERT WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE DIAMOND KNURLED KNOB BROKE FROM THE SHAFT AT THE LASER BEAM WELD. THE INNER DIAMETER OF THE KNURLED KNOB WAS ASSESSED, AS WELL AS THE THICKNESS OF THE COMPONENT, AND BOTH VALUES WERE DETERMINED TO FALL WITHIN DESIGN TOLERANCES. ADDITIONALLY, THE DIAMETER OF THE DISTAL END OF THE SHAFT (AT THE INTERFACE POINT WITH THE INNER DIAMETER OF THE KNOB) WAS ASSESSED AND FOUND TO FALL WITHIN DESIGN TOLERANCE. SURFACE DAMAGE WAS NOTED ACROSS THE LASER MARKED SURFACE OF THE KNURLED KNOB, AS WELL AS ALONG THE OUTER DIAMETER OF THE COMPONENT. THE OBSERVED CONDITION OF THE INSERT IS MOST LIKELY THE RESULT OF USER APPLIED MECHANICAL FORCES TO THE DEVICE DURING USE.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.4 MM RING OF THE DEVICE DETACHED FROM THE SLEEVE AND BROKE OFF DURING AN ARTHROSCOPY SURGERY. NO PART BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 29-APR-2021: IT WAS CONFIRMED THAT THE RING OF THE DEVICE BROKE OF DURING PULLING OUT WHILE THE SURGEON WAS WORKING WITH THE DEVICE IN THE PATIENT. THERE WAS NO HARM FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699865 INSERT 2.4 MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. INSERT 2.4 MM 012035 00888867004528

    Patients

    Seq Age Sex Outcome Treatment
    1