BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1

    MDR report key: 5197496 · Received November 3, 2015

    Report

    Report Number
    3005985723-2015-00231
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 16, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO CORRECT SECTION AND TO UPDATE BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: AN EVENT REGARDING REAMER SELECTION , INVOLVING A RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1, CATALOG: 211355 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 337 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 211355) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING REAMER SELECTION . THERE WERE NO OTHER REPORTED EVENTS FOR THE LISTED CATALOG NUMBER. CONCLUSIONS: SESSION DATA WAS NOT PROVIDED AFTER MULTIPLE COMMUNICATIONS, THEREFORE THE EXACT STEPS TO REPRODUCE THE DESCRIBED ISSUE COULD NOT BE CONFIRMED. ATTEMPTS WERE MADE TO REPLICATE THE EVENT DESCRIBED, HOWEVER THE EVENT WAS NOT ABLE TO BE REPRODUCED. SESSION FILES WERE NOT PROVIDED FOR EVALUATION.

    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 HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) .DURING THE SURGERY, THE SURGEON REAMED WITH A 55 REAMER ON A VARIABLE ANGLE END EFFECTOR WITH REAMER SHAFT SET ON 45 OFFSET. UPON RETURNING TO THE CUP REAMING PAGE AND PASSING THE REQUESTED CHECKPOINT THE REAMER SIZE WAS SET CORRECTLY AT 57, BUT THE SOFTWARE HAD REVERTED BACK TO A STRAIGHT REAMER SHAFT EVEN THOUGH AN OFFSET REAMER SHAFT SET AT 45 DEGREES HAD BEEN USED FOR RIO REGISTRATION AND THE PREVIOUS REAMING STEP. THE CASE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) .DURING THE SURGERY, THE SURGEON REAMED WITH A 55 REAMER ON A VARIABLE ANGLE END EFFECTOR WITH REAMER SHAFT SET ON 45 OFFSET. UPON RETURNING TO THE CUP REAMING PAGE AND PASSING THE REQUESTED CHECKPOINT THE REAMER SIZE WAS SET CORRECTLY AT 57, BUT THE SOFTWARE HAD REVERTED BACK TO A STRAIGHT REAMER SHAFT EVEN THOUGH AN OFFSET REAMER SHAFT SET AT 45 DEGREES HAD BEEN USED FOR RIO REGISTRATION AND THE PREVIOUS REAMING STEP. THE CASE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727975 RIO®UPGRADE DISK PKA 2.5.6.2 AND THA 3.1 STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention