BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISSECTOR, 3.0MM X 7CM

    MDR report key: 18574318 · Received January 24, 2024

    Report

    Report Number
    1220246-2024-00511
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 5, 2024
    Report Date
    March 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    UDI-DI
    00888867211834
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THE CAUSE OF THE REPORTED FAILURE. THE CAUSE OF THE REPORTED FAILURE IS AN INTERNAL MANUFACTURING PROCESS ISSUE. PER QSD-000100294 REV 21, STANDARD INSPECTION PROCEDURE FOR SHAVER, BURRS, SAW BLADES, POWER PICKS, RASP AND HANDPIECE COMPONENTS, VISUAL INSPECTION ITEM 7: MUST BE FREE OF BURRS, CRACKS, OBVIOUS SCRATCHES, NICKS, GOUGES. NCR-28975 WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURES THAT DISPLAY THE OUTER TUBE WINDOW OF AN AR-9300DS DISSECTOR, SMALL HUB, 3.0 MM X 7 CM DAMAGED.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 5TH JANUARY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-9300DS, DISSECTOR, SMALL HUB, 3.0 MM X 7 CM, HAD A MANUFACTURING PROBLEM. THIS WAS DETECTED DURING AN ARTHROSCOPIC ANKLE AND LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(4) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON DECIDED TO USE SABRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191314 DISSECTOR, 3.0MM X 7CM POWERED SURG ORTHOPEDIC INSTR GFA ARTHREX, INC. DISSECTOR, 3.0MM X 7CM 15137961 00888867211834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown