BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 7780605 · Received August 14, 2018

    Report

    Report Number
    3005985723-2018-00486
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 12, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486003128
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BLUE PLASTIC TIP TIBIAL IMPACTOR BROKE. THE DEVICE WAS NOT RETURNED. VISUAL INSPECTION OF THE AVAILABLE IMAGE OF THE DEVICE NOTED THAT THE DEVICE WAS FRACTURED IN TWO PARTS. THE DEVICE WAS DISCOVERED AFTER THE PKA PROCEDURE. THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    BLUE PLASTIC TIP TIBIAL IMPACTOR BROKE (RESTORIS MCK). AFTER NUMEROUS CYCLES THROUGH AN AUTOCLAVE, THE POLYMER WEARS OUT.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE DISCARDED.

    Description of Event or Problem · 1

    BLUE PLASTIC TIP TIBIAL IMPACTOR BROKE (RESTORIS MCK). AFTER NUMEROUS CYCLES THROUGH AN AUTOCLAVE, THE POLYMER WEARS OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623146 TIBIAL INLAY IMPACTOR HEAD KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P NPJ MAKO SURGICAL CORP. UNKNOWN 00848486003128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other