BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K7-1990-50 90.0 X 19.0 MM 1.27+

    MDR report key: 16742222 · Received April 14, 2023

    Report

    Report Number
    2025102-2023-00001
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 14, 2023
    Manufacturer
    BRASSELER USA
    Product Code
    GFA
    UDI-DI
    00887919526230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS CONSISTENT WITH A PREVIOUS INVESTIGATION THAT WAS PERFORMED FOR A SIMILAR PRODUCT FAILURE. THERE WERE DEEP GOUGES ON THE TOP AND BOTTOM SURFACES OF THE BLADE THAT ARE CONSISTANT WITH EXCESS TORQUE BEING APPLIED. IN ADDITION, THERE ARE INDENTATIONS ON THE SIDES OF THE BLADE AND ROUNDING ON THE TEETH THAT WOULD INDICATE THE BLADE MADE CONTACT WITH SOMETHING HARDER THAN BONE. MONITORING OF THIS TYPE OF FAILURE, THIS DOES NOT REPRESENT A TREND, WE WILL CONTINUE TO MONITOR. REPORTING OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A LARGE BONE BLADE BROKE WHILE MAKING FEMORAL CUTS IN A TOTAL KNEE PROCEDURE WHILE MAKING THE FEMUR CUT. THE PATIENT WAS NOT INJURED. MEDWATCH FORM 5115967 WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393135 K7-1990-50 90.0 X 19.0 MM 1.27+ SAW BLADE GFA BRASSELER USA 5010175M0 NW5J8 00887919526230

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male