BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOLBEL RETRTR BLADE,36MMX 68MMBLNT

    MDR report key: 21420640 · Received February 20, 2025

    Report

    Report Number
    1220246-2025-00564
    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
    00888867138506
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-9260-47 KOLBEL RETRACTOR BLADE, 36 MM X 36 MM, BLUNT, BATCH 45552230 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 02/06/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) 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
    1095954 KOLBEL RETRTR BLADE,36MMX 68MMBLNT RETRACTOR GFA ARTHREX, INC. KOLBEL RETRTR BLADE,36MMX 68MMBLNT 00888867138506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown