BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBFIX BLU SYSTEM CROSS DRIVE BLADE, LONG

    MDR report key: 8636601 · Received May 23, 2019

    Report

    Report Number
    0001032347-2019-00295
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00084103617759
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE BLADES WERE VISUALLY EVALUATED AND FOUND TO SHOW SOME SIGNS OF USE WITH MINIMAL SCRATCHING ON THE SHAFTS AND SLIGHT WEAR ON THE CROSS-DRIVE INTERFACES. FUNCTIONAL TESTING WAS DONE ON THE BLADES TO TEST RETENTION. THE BLADES WERE INSERTED INTO A RATCHETING DRIVER AND THE CROSS-DRIVE INTERFACES WERE INSERTED INTO A SCREW. THE ASSEMBLY WAS THEN LIFTED BY THE SCREW AND THE RETENTION WAS VERIFIED, AS THE INTERFACES WERE ABLE TO SUPPORT THE WEIGHT OF THE BLADE AND DRIVER. THE COMPLAINT IS UNCONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE REPORTED EVENT WAS NOT SUBSTANTIATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00109-2, 0001032347-2019-00110-2, 0001032347-2019-00111-2, 0001032347-2019-00293, 0001032347-2019-00294, 0001032347-2019-00296.

    Description of Event or Problem · 1

    IT WAS REPORTED THESE BLADES WERE DULL. THIS WAS NOTED DURING INVENTORY INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429439 RIBFIX BLU SYSTEM CROSS DRIVE BLADE, LONG BLADE HRS BIOMET MICROFIXATION N/A 698680 00084103617759

    Patients

    Seq Age Sex Outcome Treatment
    1