BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL TRIAL SLAPHAMMER

    MDR report key: 4871039 · Received June 26, 2015

    Report

    Report Number
    3005985723-2015-00116
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE SURGEON WAS INCORRECTLY TRYING TO USE THE SUBJECT DEVICE FOR INSERTION. ACCORDING TO THE SURGICAL PROTOCOL, REF# (B)(4) VERSION REVISION #02, THE DEVICE CAN ONLY BE USED FOR EXTRACTION AND NOT FOR INSERTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE SLAPHAMMER WORKS FOR TRIAL EXTRACTION, BUT IT DOES NOT SECURE THE TRIAL IN AXIAL ROTATION, MAKING IT DIFFICULT TO USE FOR TRIAL INSERTION.

    Description of Event or Problem · 1

    THE SLAPHAMMER WORKS FOR TRIAL EXTRACTION, BUT IT DOES NOT SECURE THE TRIAL IN AXIAL ROTATION, MAKING IT DIFFICULT TO USE FOR TRIAL INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416658 FEMORAL TRIAL SLAPHAMMER INSTRUMENT NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other