BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KM-250R 60.0 X 6.33MM RECIP 0.64MM MAT THK / 1.04MM CUT THK

    MDR report key: 19510304 · Received June 11, 2024

    Report

    Report Number
    2025102-2024-00006
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFA
    UDI-DI
    00887919434689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED AN IMAGE OF THE PRODUCT ON (B)(6) 2024. IMAGE SHOWS BLADE IS BENT LATERALLY. FOR THE INVESTIGATION, REVIEWED IFU ON LATERAL FORCE. PER IFU-0035 REV E BUSA EU CONSUMABLE ACCESSORIES IFU "DO NOT USE EXCESSIVE, LATERAL, TWISTING OR BENDING FORCES TO PREVENT CONSUMABLE ACCESSORY FAILURE SUCH AS BENDING OR BREAKAGE. " REVIEWED MANUFACTURING DHR FOR IN-PROCESS AND FINAL INSPECTION DIMENSIONS AND MATERIAL RECEIPT FOR MATERIAL COMPOSITION. BOTH WERE FOUND WITHIN SPECIFICATION WHEN REVIEWED WITH DRAWING. THE BLADE IS A RECIPROCATING SAWBLADE INTENDED FOR FORWARD / BACKWARD MOTION. REVIEWING OF IMAGE SHOWS USE OF EXCESSIVE LATERAL FORCE CAUSING BLADE TO BEND IN UNINTENDED DESIGN. THE MOST LIKELY ROOT CAUSE IS USER ERROR FROM ATTEMPTING TO USE THE BLADE INCORRECTLY.

    Description of Event or Problem · 0

    WHILE PERFORMING A HIP REPLACEMENT, THE BLADE BENT DURING SURGERY. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170559 KM-250R 60.0 X 6.33MM RECIP 0.64MM MAT THK / 1.04MM CUT THK SAW BLADE GFA BRASSELER U.S.A. MEDICAL, LLC NZ0G6 00887919434689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown