BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 8169194 · Received December 17, 2018

    Report

    Report Number
    3005985723-2018-00756
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 19, 2018
    Report Date
    March 15, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NO PRODUCT WAS RETURNED FOR INSPECTION HOWEVER TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW THE BLUE SECTION/FOOT WITH LOT CATALOG NUMBER 160177 AND LOT CODE 19060715 FRACTURED OFF THE TIBIAL IMPACTOR. DAMAGE IS VISIBLE ON THE ON THE BLUE FOOT ATTACHMENT. 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 REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN TWO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. (B)(4) & (B)(4) RELATES TO CRACK/FRACTURE. CONCLUSION: AN EVENT REGARDING CRACK/FRACTURE OF A MAKO IMPACTOR WAS REPORTED. NO PRODUCT WAS RETURNED FOR INSPECTION HOWEVER TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW THE BLUE SECTION/FOOT WITH LOT CATALOG NUMBER 160177 AND LOT CODE 19060715 FRACTURED OFF THE TIBIAL IMPACTOR. DAMAGE IS VISIBLE ON THE ON THE BLUE FOOT ATTACHMENT. THE EXACT CAUSE OF THE EVENT CANNOT BE CONFIRMED AS INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN AND IMAGES OF THE DEVICE TAKEN WHEN THE EVENT OCCURRED ARE REQUIRED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. 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 PIECE ON THE BASEPLATE IMPACTOR. NO ADVERSE CONSEQUENCES AS WE JUST OPENED ANOTHER ONE. THE BLUE PIECE ON THE TIBIAL BASEPLATE IMPACTOR CRACKED AND BROKE OFF DURING IMPACTION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    BLUE PIECE ON THE BASEPLATE IMPACTOR. NO ADVERSE CONSEQUENCES AS WE JUST OPENED ANOTHER ONE. THE BLUE PIECE ON THE TIBIAL BASEPLATE IMPACTOR CRACKED AND BROKE OFF DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011138 TIBIAL INLAY IMPACTOR HEAD KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P NPJ MAKO SURGICAL CORP. 19060715

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O