BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 8190093 · Received December 21, 2018

    Report

    Report Number
    3005985723-2018-00767
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 27, 2018
    Report Date
    March 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN ONE OTHER SIMILAR EVENT FOR THE LOT REFERENCED. CONCLUSION: THE INVESTIGATION COULD NOT CONFIRM THE REPORTED EVENT AS THE TIP WAS NOT RETURNED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIVE/PREVENTIVE ACTION: NC WAS INITIATED ON 15 DECEMBER 2017 DUE TO THE OCCURRENCE RATE FOR CRACK/FRACTURE OF MCK TIBIAL BASEPLATE IMPACTOR HEAD. SCOPE OF THIS CAPA INCLUDES THE CATALOG NUMBER 160177, IMPACTOR HEAD, THE TIBIAL IMPACTOR HEAD AND THE TIBIAL IMPACTOR HANDLE (CATALOG NO. 160173) ARE SUBCOMPONENTS WHICH ARE PART OF THE TIBIAL IMPACTOR (CATALOG NO. 160195).

    Description of Event or Problem · 0

    PLASTIC ATTACHMENT OF THE TIBIAL INLAY IMPACTOR HEAD BROKE. THE IMPACTOR HEAD WAS USED WITHOUT THE PLASTIC ATTACHMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PLASTIC ATTACHMENT OF THE TIBIAL INLAY IMPACTOR HEAD BROKE. THE IMPACTOR HEAD WAS USED WITHOUT THE PLASTIC ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030511 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 19441216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other