BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACK SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM

    MDR report key: 24245224 · Received February 3, 2026

    Report

    Report Number
    3010470577-2025-10161
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    August 27, 2025
    Report Date
    November 22, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    GFF
    PMA / PMN Number
    K191380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A

    Description of Event or Problem · 0

    THE (B)(6) REPORTED THAT: "WE ENCOUNTERED DIFFICULTIES DURING TWO PROCEDURES USING SHANNON Ø2 L 20MM DRILLS, REF. G010511. THREE DRILLS BROKE DURING THE SAME PROCEDURE, FROM BATCH 2502104."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305165 PACK SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM SHANNON BURRS GFF IN2BONES SAS G01 01511 2502104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown