BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 20999852 · Received December 23, 2024

    Report

    Report Number
    1220246-2024-09005
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 22, 2024
    Report Date
    February 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9676 ANGLED REAMER, DRIVE SHAFT BATCH NUMBER: 022338 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED STRIATIONS ON BOTH THE PROXIMAL AND DISTAL ENDS OF THE DEVICE. IT WAS FURTHER NOTED THAT THERE WERE NICKS AND DENTS ON THE SHAFT NEAR THE HUDSON-CONNECTION AREA. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO INSERT THE RETURNED AR-9676 ANGLED REAMER, DRIVE SHAFT INTO A KNOWN GOOD AR-9597-10. IT WAS NOTED THAT THE AR-9676 ANGLED REAMER, DRIVE SHAFT WAS MET WITH RESISTANCE AND FRICTION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT AND AN AR-9597-20 ANGLED REAMER SLEEVE, 20° HAD AN ISSUE AT THE END OF THE REAMING FOR THE AUGMENT. IT SEEMED TO LOCK UP AND THE OUTER SLEEVE WAS POPPED OFF A BIT FROM THE INNER SLEEVE AND SEEMS IT CREATED SOME SPURS AND CUTS (SEE PHOTOS). THEY WERE ABLE TO FINISH THE CASE WITHOUT ANY ISSUES. THIS WAS DISCOVERED DURING A REVERS AUGMENTED MGS SHOULDER REPLACEMENT PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/03/2024: THIS WAS DISCOVERED DURING A REVERS AUGMENTED MGS SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88135 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown