BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL TRIAL SLAPHAMMER

    MDR report key: 8090081 · Received November 20, 2018

    Report

    Report Number
    3005985723-2018-00684
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 8, 2018
    Report Date
    January 7, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486002732
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A FEMORAL TRIAL SLAPHAMMER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS. CONCLUSIONS: THE REPORTED EVENT CANNOT BE CONFIRMED, OR THE ROOT CAUSE DETERMINED AS THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 0

    ITEM BROKEN. SCREW END STUCK INTO ITEM: 170513.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ITEM BROKEN. SCREW END STUCK INTO ITEM 170513.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929453 FEMORAL TRIAL SLAPHAMMER PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 06010416 00848486002732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other