BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GLENOID CORRECTION REAMER

    MDR report key: 19428049 · Received May 30, 2024

    Report

    Report Number
    1220246-2024-04429
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    September 22, 2022
    Report Date
    May 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT IS PARTIALLY CONFIRMED, THERE ARE NO ISSUES WITH THE CONNECTOR, BUT THE REAMER IS DULL. ONE UNPACKAGED AR-9126RC BATCH NUMBER 250110800 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE CURRENT INSTRUMENTS USE A HYBRID HUDSON ZIMMER ADAPTER GEOMETRY. THIS DEVICE BELONGS TO A PREVIOUS REVISION THAT USES A MODIFIED ZIMMER ADAPTER GEOMETRY. THE MORE IN-DEPTH VISUAL EVALUATION FOUND GOUGES ON THE HEAD FLUTES. LASER MARKS ARE FADING. THE CAUSE CAN BE ATTRIBUTED TO WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INVERSE PROSTHESIS SURGERY THE DEVICE WAS DEFECTIVE AND DULL. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 29-SEP-2022: FURTHER INFORMATION WAS RECEIVED WITH THE DEVICE. THE REAMER DOES NOT FIT INTO THE DRILLING MACHINE. UPDATE AVOE 10-OCT-2022: IT WAS CONFIRMED THAT BOTH FAILURE DESCRIPTIONS APPLY. THE DEVICE WAS DEFECTIVE AND DULL AND DIDN`T FIT INTO THE DRILLING MACHINE. UPDATE AVOE 28-DEC-2022: IT WAS FURTHER CONFIRMED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. UPDATE AVOE 04-JAN-2023: IT WAS CONFIRMED THAT THE REPORTED DEVICE WAS USED WITH A DEVICE FROM ANOTHER MANUFACTURER (STRYKER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274879 UNIVERSAL GLENOID CORRECTION REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERSAL GLENOID CORRECTION REAMER 250110800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown