BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KM71-523 LG BONE POWER PRO OSC STANDARD 97.0X19.5MM

    MDR report key: 17632778 · Received August 28, 2023

    Report

    Report Number
    2025102-2023-00002
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BRASSELER USA
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BRASSELER IS REPORTING THIS ALLEGED PRODUCT MALFUNCTION IN AN ABUNDANCE OF CAUTION. THE ALLEGATIONS OF MALFUNCTION HAVE NOT BEEN CONFIRMED DUE TO THE INABILITY OF BRASSELER TO PERFORM AN INVESTIGATION OF THE PRODUCT WHICH WAS NOT RETURNED BY THE CUSTOMER. BRASSELER WILL FOLLOW UP WITH A SUPPLEMENTAL REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THE NON-WORKING END (END GOES IN DRILL) PIECE OF METAL BROKE OFF INTO PATIENT'S WOUND. PIECE WAS RETRIEVED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459823 KM71-523 LG BONE POWER PRO OSC STANDARD 97.0X19.5MM LARGE BONE BLADE GFA BRASSELER USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female