BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR,OVAL,FLUSHCUT,8 FLUT,5.5MMX 13CM

    MDR report key: 23294288 · Received October 15, 2025

    Report

    Report Number
    1220246-2025-04588
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 6, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    UDI-DI
    00888867044012
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. VISUAL EVALUATION REVEALED THAT THE INNER HUB WAS BROKEN OFF. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. PER DFU-0215-EO - I. DEVICE INSERTION AND REMOVAL - FOR USE WITH HAND-CONTROLLED AND NON-HAND-CONTROLLED HANDPIECES: 1. TO INSERT A DISPOSABLE DEVICE, INSERT THE DEVICE INTO THE HANDPIECE SO THAT THE PLASTIC TAB MATES WITH THE HANDPIECE SLOT. THE TAB SHOULD BE PUSHED IN PROXIMALLY AS FAR AS POSSIBLE FOR A POSITIVE LOCK. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER CONNECTION WITH THE HANDPIECE AND/OR EXCESSIVE FORCE USED DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY THAT THE DEVICE BROKE OUT OF ITS MOUNT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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
    2337039 BUR,OVAL,FLUSHCUT,8 FLUT,5.5MMX 13CM BURR,SURGICAL GFF ARTHREX, INC. BUR,OVAL,FLUSHCUT,8 FLUT,5.5MMX 13CM 15386972 00888867044012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown