BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HANDLE, RATCHETING

    MDR report key: 17098378 · Received June 9, 2023

    Report

    Report Number
    1220246-2023-06885
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 12, 2023
    Report Date
    August 21, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867025936
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-1999 SERIAL/BATCH NUMBER 8002026 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE INSTRUMENT RATCHETING SYSTEM WAS DISASSEMBLY. PER DHR REVIEW CERTIFICATE OF CONFORMANCE MANUFACTURING YEAR 2020. IT IS STILL BEING DETERMINED HOW MANY CLEANING CYCLES THE DEVICE HAS BEEN EXPOSED TO. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE APPLYING EXCESSIVE FORCES THROUGH LEVERAGING/PRYING THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE SURGERY THE BEARING OF THE DEVICE BROKE. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 AVOE (B)(6) 2023: IT WAS CONFIRMED THAT NO BROKEN PARTS FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452022 SCREWDRIVER HANDLE, RATCHETING ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SCREWDRIVER HANDLE, RATCHETING 8002026 00888867025936

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown