BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL TRIAL SLAPHAMMER

    MDR report key: 6088801 · Received November 9, 2016

    Report

    Report Number
    3005738134-2016-00003
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    August 24, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. AN EVENT REGARDING CRACK/FRACTURE INVOLVING A FEMORAL TRIAL SLAPHAMMER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. -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 HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ADDED TO AGE OR DATE OF BIRTH. AN EVENT REGARDING DAMAGE INVOLVING A FEMORAL TRIAL SLAPHAMMER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RETURNED IN USED CONDITION. THE TIP OF THE SLAP HAMMER BROKE OFF AND REMAINED INSIDE THE FEMORAL TRIAL. EXAMINATION OF THE RETURNED DEVICE WITH MATERIAL ANALYSIS ENGINEER INDICATED THAT THE DEVICE FRACTURE CONSISTENT WITH AN OVERLOAD CONDITION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW: NO OTHER EVENTS WERE REPORTED FOR THE LOT INDICATED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE DEVICE FRACTURED DUE TO AN OVERLOAD CONDITION. EXAMINATION OF THE RETURNED DEVICE WITH MATERIAL ANALYSIS ENGINEER INDICATED THAT THE DEVICE FRACTURE CONSISTENT WITH AN OVERLOAD CONDITION.

    Description of Event or Problem · 1

    THE DOCTOR USED THE SLAP HAMMER TO REMOVE THE TRIAL THE THREADED TIP BROKE OFF IN THE TRIAL. THE THREADED TIP IS STUCK IN THE TRIAL AND HAS NOT BEEN ABLE TO BE REMOVED.

    Description of Event or Problem · 1

    THE DOCTOR USED THE SLAP HAMMER TO REMOVE THE TRIAL THE THREADED TIP BROKE OFF IN THE TRIAL. THE THREADED TIP IS STUCK IN THE TRIAL AND HAS NOT BEEN ABLE TO BE REMOVED.

    Description of Event or Problem · 1

    THE DOCTOR USED THE SLAP HAMMER TO REMOVE THE TRIAL THE THREADED TIP BROKE OFF IN THE TRIAL. THE THREADED TIP IS STUCK IN THE TRIAL AND HAS NOT BEEN ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742779 FEMORAL TRIAL SLAPHAMMER PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ MAKO SURGICAL CORP. 06061114

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other