BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET CUP REAMER HANDLE

    MDR report key: 5745829 · Received June 23, 2016

    Report

    Report Number
    3005985723-2016-00193
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 15, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE WELD HOLDING THE LONG PIN IN THE PROXIMAL U-JOINT OF THE OFFSET REAMER HANDLE BROKE ALLOWING THE PIN TO DISASSOCIATE AND CONTACT THE SHELL OF THE HANDLE. THIS CONTACT RESULTED IN DEBRIS ENTERING THE WOUND WHICH WAS REMOVED WITH A DELAY OF LESS THAN 10 MINUTES. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION SHOWS THE WELD HOLDING THE LONG PIN IN THE PROXIMAL U-JOINT HAS FAILED CAUSING THE PIN TO DISASSOCIATE FROM THE U-JOINT AND IS NO LONGER PRESENT IN THE DEVICE. THERE IS SOME ADDITIONAL DEFORMATION IN THE YOKES OF THE U-JOINT AS THESE TWO PIECES CONTACTED EACH OTHER DUE TO THE MISSING PIN. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION CANNOT BE COMPLETED DUE TO THE DAMAGE OF THE U-JOINT. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION SHOWS THE REAMER HANDLE STILL ROTATES; HOWEVER, THERE IS A LARGE AMOUNT OF TOGGLE IN THE U-JOINT. THIS IS CONSISTENT WITH THE COMPLAINT REPORT AS THE JOINT WAS STILL ABLE TO SPIN CAUSING THE PIN TO HIT THE SHELL OF THE HANDLE AS THE PIN DISASSOCIATED FROM THE U-JOINT. THIS ISSUE IS BEING ADDRESSED THROUGH NC 1192737. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 9/9/2015. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 207080, LOT NUMBER 32010815 SHOWS ONE ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THIS COMPLAINT IS PR 1104270. TRACKING OF COMPLAINTS RELATED TO THE 207080 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #856. CONCLUSIONS: THE FAILURE MODE IN THIS INVESTIGATION IS CONSISTENT WITH THAT SEEN WITHIN THE SCOPE OF NC 1192737. CORRECTIVE ACTION/PREVENTIVE ACTION: NC 1192737 HAS BEEN OPENED TO ADDRESS THE FAILURE IN THIS COMPLAINT. ALL CORRECTIONS AND PREVENTATIVE ACTIONS WILL BE COMPLETED PER THIS NC. NO FURTHER ACTION IS REQUIRED FROM THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE SURGEON NOTICED METAL SHAVINGS COMING OFF OF THE REAMER HANDLE INTO THE INCISION WHILE HE WAS REAMING, THE DOCTOR REMOVED ALL METAL SHAVINGS. THE CASE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE SURGEON NOTICED METAL SHAVINGS COMING OFF OF THE REAMER HANDLE INTO THE INCISION WHILE HE WAS REAMING, THE DOCTOR REMOVED ALL METAL SHAVINGS. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399058 OFFSET CUP REAMER HANDLE STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. 32010815

    Patients

    Seq Age Sex Outcome Treatment
    1 Other