BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    MDR report key: 8636588 · Received May 23, 2019

    Report

    Report Number
    0001032347-2019-00293
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036140984
    PMA / PMN Number
    K161896
    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 CONFIRMED. THE BLADES WERE VISUALLY EVALUATED AND FOUND TO HAVE SOME SLIGHT BROWNISH RESIDUE PRESENT. THE RESIDUE WAS NOT ABLE TO BE WIPED AWAY WITH ALCOHOL AND A WIPE. THE COMPLAINT IS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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, 0001032347-2019-00294, 0001032347-2019-00295, 0001032347-2019-00296.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS ITEM WAS DULL AND RUSTED. THIS WAS NOTED DURING INVENTORY INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429257 STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER BLADE HRS BIOMET MICROFIXATION N/A 194960 00841036140984

    Patients

    Seq Age Sex Outcome Treatment
    1