BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8871206 · Received August 7, 2019

    Report

    Report Number
    3005985723-2019-00577
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 22, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 338 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS SIMILAR COMPLAINTS FOR PKA SOFTWARE - INACCURATE RESECTION. THE COMPLAINT RECORD NUMBERS ARE: (B)(4). CONCLUSION: A REVIEW OF THIS CASE SHOWS MINIMAL IRREGULARITIES IN THE PROCEDURE. BONE REGISTRATION ERROR WAS WITHIN AN ADEQUATE RANGE AND ALL VERIFICATION SPHERES WERE PASSED. THERE WERE NO VELOCITY TRAPS AND NOTHING TO SUGGEST MOVEMENT WITH ARRAYS. I WAS ABLE TO VERIFY THE SURGEONS WORKFLOW AND CONFIRMED THAT IT WAS NECESSARY FOR HIM/HER TO ADJUST TO A SMALLER IMPLANT AND RECUT. IT IS NOT CLEAR IF THE SIZE 5 IMPLANT WAS WHAT WAS IMPLANTED AFTER HOWEVER. THE GAP ANALYSIS DURING FINAL TRIALING LOOK GOOD WITH ALL POSES SHOWING MINIMAL TIGHTNESS/LOOSENESS IN THE SOFT TISSUE. BASED ON THE DATA FORM THE CASE IT DOES NOT APPEAR THE APPLICATION BEHAVED IN AN UNINTENDED MANOR.

    Description of Event or Problem · 0

    THE SIZE 6 PKA FEMORAL TRIAL DID NOT FIT AFTER WE BURRED FOR A SIZE 6 PKA LEFT MEDIAL FEMORAL TRIAL. HAD TO DOWNSIZE TO A SIZE 5 LEFT MEDIAL TRIAL, MOVE THE IMPLANT APPROX 1 MM PROXIMAL, REBURR AND THEN RE-TRIAL. SESSION FILES,LOGS, ETC ARE LOADED IN COMPLAINTS FOLDER UNDER (B)(4). CASE TYPE: PKA. SURGICAL DELAY: 16-30 MINUTES.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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 SIZE 6 PKA FEMORAL TRIAL DID NOT FIT AFTER WE BURRED FOR A SIZE 6 PKA LEFT MEDIAL FEMORAL TRIAL. HAD TO DOWNSIZE TO A SIZE 5 LEFT MEDIAL TRIAL, MOVE THE IMPLANT APPROX 1 MM PROXIMAL, REBURR AND THEN RE-TRIAL. SESSION FILES, LOGS, ETC ARE LOADED IN COMPLAINTS FOLDER UNDER "(B)(4)." CASE TYPE: PKA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663628 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization