BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE KIT HIP FOR 1.8MM Q-FIX IMP

    MDR report key: 24702562 · Received March 26, 2026

    Report

    Report Number
    3006524618-2026-00150
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 10, 2026
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    UDI-DI
    00885556724620
    PMA / PMN Number
    K241435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL INFORMATION REVIEWED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE DISPOSABLE KIT HIP FOR 1.8MM Q-FIX IMP DOES NOT INCLUDE A Q-FIX ANCHOR IN THE KIT, THIS DEVICE IS CONSIDERED A CONCOMITANT DEVICE, THEREFORE, THERE IS NO IMPACT OR INJURY TO A PATIENT. THIS EVENT IS CONSIDERED NOT REPORTABLE PER APPLICABLE REGULATIONS. IF ADDITIONAL DETAILS CONFIRM THE OCCURRENCE OF A REPORTABLE EVENT, WE WILL UPDATE OUR RECORDS ACCORDINGLY AND SUBMIT A SUBSEQUENT REPORT DETAILING BOTH THE EVENT AND OUR COMPLETED INVESTIGATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A BANKART REPAIR, A DISPOSABLE XL 1.8MM Q-FIX DRILL GUIDE WAS INSERTED PERCUTANEOUSLY INTO THE JOINT. THE CONVENTIONAL 1.8MM DRILL BIT WAS USED TO PREPARE THE ANCHOR HOLE IN THE GLENOID. A 1.8MM Q-FIX KNOTLESS ALL SUTURE ANCHOR WAS DEPLOYED IN A ROUTINE MANNER. AS THE ANCHOR HANDLE WAS BEING REMOVED FROM THE DRILL GUIDE, WHICH STAYED IN THE JOINT, THE TRANSFER SUTURE RUPTURED APPROXIMATELY 5-10MM FROM THE ANCHOR BALL. THIS RUPTURE MADE THE ANCHOR UNUSABLE AS THE REPAIR SUTURE COULD NOT BE SHUTTLED THROUGH THE ANCHOR'S INTERNAL LOCKING MECHANISM. A 1.8MM Q-FIX DISPOSABLE KIT XL (REF: 25-1811) WAS USED TO PREPARE THE INSERTION SITE AND ALL THE SITE WAS CLEARD OF ALL DEBRIS PRIOR TO THE INSERTION. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A CONMED Y-KNOT, 1.3MMCOMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905 DISPOSABLE KIT HIP FOR 1.8MM Q-FIX IMP FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION 2187504 00885556724620

    Patients

    Seq Age Sex Outcome Treatment
    1