BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL TRIAL SLAPHAMMER

    MDR report key: 5013584 · Received August 19, 2015

    Report

    Report Number
    3005985723-2015-00144
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE OF A FEMORAL TRIAL SLAPHAMMER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. 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 EVENTS FOR THE LOT REFERENCED. CONCLUSION: THE EVENT COULD NOT BE CONFIRMED BUT BASED ON THE PROVIDED INFORMATION, THE ROOT CAUSE WAS LIKELY DUE TO USER ERROR AS THE FEMORAL TRIAL IS INTENDED TO BE IMPACTED, NOT THE REPORTED SLAPHAMMER. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER

    Description of Event or Problem · 1

    DURING INSERTION OF THE FEMORAL TRIAL, DR. USED A MALLET TO STRIKE THE 111140 INSERTER/EXTRACTOR AND THE THREADED TIP BROKE OFF INSIDE THE TRIAL. NO ISSUES AROSE FROM THIS INCIDENT AS DR. WAS ABLE TO REMOVE THE TRIAL BY HAND. I ADVISED HIM THAT THE INSTRUMENT WAS NOT INTENDED FOR IMPACTION WITH A MALLET AS WE PROVIDE A SEPARATE IMPACTOR IN THE TRAY.

    Description of Event or Problem · 1

    DURING INSERTION OF THE FEMORAL TRIAL, DR. USED A MALLET TO STRIKE THE 111140 INSERTER/EXTRACTOR AND THE THREADED TIP BROKE OFF INSIDE THE TRIAL. NO ISSUES AROSE FROM THIS INCIDENT AS DR. WAS ABLE TO REMOVE THE TRIAL BY HAND. I ADVISED HIM THAT THE INSTRUMENT WAS NOT INTENDED FOR IMPACTION WITH A MALLET AS WE PROVIDE A SEPARATE IMPACTOR IN THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547949 FEMORAL TRIAL SLAPHAMMER INSTRUMENT NPJ MAKO SURGICAL CORP. 06030813 06030813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other