BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADED DRILL FOR FEMORAL A/P SIZER

    MDR report key: 6982717 · Received October 27, 2017

    Report

    Report Number
    3008021110-2017-00094
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HRY
    PMA / PMN Number
    K141934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANOMALY DETECTED BY CHECKING THE DHR OF THE LOT# INVOLVED ON A TOTAL OF (B)(4) PIECES MANUFACTURED WITH THE SAME LOT #(2014AA618). WE WILL SUBMIT A FINAL EMDR WHEN THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE DRILL BIT BREAKAGE HAPPENED DURING A KNEE SURGERY ON (B)(6) 2017. ACCORDING TO THE INFO REPORTED, NO SURGERY TIME NOR COMPLICATIONS FOR THE PATIENT OCCURRED DUE TO THIS ISSUE. ESTIMATED NUMBER OF USES OF THE DRILL BIT: APPROX 12. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764835 HEADED DRILL FOR FEMORAL A/P SIZER HEADED DRILL FOR FEMORAL A/P SIZER HRY LIMACORPORATE S.P.A. 9065.10.380 14AA618

    Patients

    Seq Age Sex Outcome Treatment
    1