BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6511897 · Received April 21, 2017

    Report

    Report Number
    3005985723-2017-00190
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    April 19, 2017
    Report Date
    June 26, 2017
    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

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AFTER REAMING THE BACK KNOB OF THE EE BROKE OFF AND THEREFORE COULDN'T DISENGAGE THE REAMER SHAFT. ALSO CRACKS WERE NOTICED AT THE END OF THE EE AT THE DEGREE NOTCHES. MARCHAND IMPACTED THE CUP MANUALLY RATHER THAN WAIT FOR A BACKUP EE TO BE OPENED AND ROBOTIC ARM REGISTERED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM WITH BALL BEARINGS FAILING AND DENTS CAN BE SEEN ON THE SLOTS OF THE 206997 HIP ENF EFFECTOR BASE, THE 202866 HIP RELEASE KNOB WAS SHEARED OFF, THERE ARE CRACKS ALONG THE ANGLE MARKERS OF THE 206966 REAMER BARRELL, AND THE 202857 DOWEL PINS ARE NOT FLUSH WITH THE SURFACE . REFERENCE ATTACHED IMAGES. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 05/11/2016 INCLUDING SERIAL NUMBER (B)(4). COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT 19400515 SHOWS 3 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: ALLEGED FAILURE CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA (B)(4) WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. AFTER REAMING THE BACK KNOB OF THE EE BROKE OFF AND THEREFORE COULDN'T DISENGAGE THE REAMER SHAFT. ALSO CRACKS WERE NOTICED AT THE END OF THE EE AT THE DEGREE NOTCHES. THE SURGEON IMPACTED THE CUP MANUALLY RATHER THAN WAIT FOR A BACKUP EE TO BE OPENED AND ROBOTIC ARM REGISTERED.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. AFTER REAMING THE BACK KNOB OF THE EE BROKE OFF AND THEREFORE COULDN'T DISENGAGE THE REAMER SHAFT. ALSO CRACKS WERE NOTICED AT THE END OF THE EE AT THE DEGREE NOTCHES. THE SURGEON IMPACTED THE CUP MANUALLY RATHER THAN WAIT FOR A BACKUP EE TO BE OPENED AND ROBOTIC ARM REGISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292259 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization