BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOLBEL RETRTR BLADE,36MMX 36MMBLNT

    MDR report key: 21420593 · Received February 20, 2025

    Report

    Report Number
    1220246-2025-00562
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 6, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    UDI-DI
    00888867138490
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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. ONE UNPACKAGED AR-9260-46 KOLBEL RETRACTOR BLADE, 36 MM X 36 MM, BLUNT BATCH 45552236 WAS RETURNED FOR INVESTIGATION. - VISUAL EVALUATION NOTED SIGNS OF WEAR/DAMAGE ON THE BODY: FADING LASER MARKS, CHIPPING MARKS, AND DISCOLORATION SPLOTCHES. - FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. - THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR, WHICH RESULTS FROM EXCESSIVE STRESS ON A DEVICE THAT HAS NATURALLY DETERIORATED OVER TIME DUE TO NORMAL USAGE AND AGING. THE MANUFACTURING DATE IS 2022. - REFER TO THE INVESTIGATION PHOTOS. - THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 02/06/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-9260-47 KOLBEL RETRACTOR BLADE, AND AN AR-9260-46 KOLBEL RETRACTOR BLADE WERE DAMAGED. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029345 KOLBEL RETRTR BLADE,36MMX 36MMBLNT RETRACTOR GFA ARTHREX, INC. KOLBEL RETRTR BLADE,36MMX 36MMBLNT 00888867138490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown