BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEX DRIVER

    MDR report key: 20200148 · Received September 12, 2024

    Report

    Report Number
    1220246-2024-07553
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9625 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION FOUND THAT THE HEX TIP WAS BROKEN. THE FRAGMENTS WEREN'T RETURNED FOR ASSESSMENT. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE IS DAMAGED. THE MOST LIKELY REASON FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO EXCESSIVE FORCES USED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 09/11/2024: THIS WAS A REVISION DUE TO THE PATIENT HAVING AN INFECTION. THE PATIENT HAS HAD A LONG HISTORY OF SHOULDER SURGERIES AND INFECTIONS, AND, THEREFORE, THIS WAS A REMOVAL OF SOME ARTHREX ARTHROPLASTY IMPLANTS WHILE OTHER IMPLANTS WERE LEFT IN PLACE. THE TIP OF THE AR-9621-35T 35 MM TAP SCREW HEAD BROKE WHEN REMOVING THE OLD HUMERAL INSERT POLY, AND THE TIP OF THE AR-9625 3.0 MM HEX DRIVER BROKE OFF INTO THE HEAD OF THE GLENOSPHERE SCREW WHEN GOING TO REMOVE THE GLENOSPHERE IMPLANT. A SMALL FRAGMENT FROM THE AR-9621-35T 35 MM TAP TIP BROKE OFF WHEN THE SURGEON REMOVED THE OLD HUMERAL INSERT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH THE GLENOSPHERE, HUMERAL INSERT, SPACER, AND SUTURE CUP REMOVED AND REPLACED WITH NEW COMPONENTS. THE BASEPLATE, CENTRAL SCREW, LOCKING SCREWS, AND HUMERAL STEM WERE LEFT IN PLACE FROM THE PREVIOUS SURGERY. THIS OCCURRED ON (B)(6) 2024 FOR A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 10/09/2024: THEY COULD NOT PROVIDE THE PART/LOT NUMBERS OF THE IMPLANTS IN THE PATIENT ON THE DAY OF THE ORIGINAL SURGERY. ALL COMPONENTS THAT WERE REMOVED FROM THE PATIENT IN THE REVISION WERE DISCARDED. THE ARTHREX PRODUCTS THAT WERE IMPLANTED AFTER THE EXTRACTION OF THE OLD COMPONENTS ARE PROVIDED BELOW: AR-9564-2436-LAT GLENOSPHERE / LOT: 23.03856. AR-9503S-03C HUMERAL INSERT / LOT:23.00580. AR-9555-15 SPACER / LOT: 23.00325. AR-9502F-36LCPC SUTURECUP / LOT: 23.02079.

    Description of Event or Problem · 0

    ON 08/23/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06643610 THAT AN AR-9625 3.0 MM HEX DRIVER HAD THE TIP BROKEN OFF IN THE AR-9621-35T 35 MM TAP SCREW HEAD. ALL FRAGMENTS WERE FOUND, AND THE CASE WAS DELAYED APPROXIMATELY 10 MINUTES. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505905 3.0MM HEX DRIVER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 3.0MM HEX DRIVER 022326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown