BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID, LARGE

    MDR report key: 12569177 · Received October 4, 2021

    Report

    Report Number
    1220246-2021-03715
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 13, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867239333
    PMA / PMN Number
    K161108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9106-03 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION IDENTIFIED BREAKAGE ACROSS THE THREADING OF THE CENTRAL POST, AS WELL AS WARPING OF THE REMAINING THREADS. DAMAGE WAS ALSO PRESENT TO THE OUTER DIAMETER OF THE GLENOID BODY. THE CAUSE REMAINS UNDETERMINED, ALTHOUGH PROBABLE CAUSES CAN BE ATTRIBUTED TO MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING THE INSERTION PROCESS.

    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 DURING A SHOULDER PROSTHETICS SURGERY TWO DEVICES BROKE INSIDE THE PATIENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464671 UNIVERS VAULTLOCK GLENOID, LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, LARGE 1027262046 00888867239333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown