BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8069720 · Received November 14, 2018

    Report

    Report Number
    3005985723-2018-00675
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 17, 2018
    Report Date
    March 7, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION DURING A TOTAL KNEE PROCEDURE INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 549 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING INACCURATE RESECTION. THERE WAS ONE OTHER REPORTED EVENT FOR THE LISTED CATALOG NUMBER (PR 1537088, PR1419895, PR1427242, PR1440996, PR1407370, PR1419895, PR1427242, PR1433496, PR1443555, PR 1449671, PR1516994, PR1528344, PR 1549560, PR 1748126, PR 1765984, PR 1757777, PR 1748590, PR1910116, PR 1940383 AND PR1910115). CONCLUSION: PRODUCT INSPECTION COULD NOT BE COMPLETED BECAUSE SESSION FILES WERE NOT PROVIDED AFTER THREE COMMUNICATIONS TO THE MPS. THE REPORTED EVENT COULD NOT BE CONFIRMED FROM THE CASE IMAGES PROVIDED. SESSION FILES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    PLANAR PROBE VS BONE MODEL MISMATCH: BONE MODEL VISUAL IS NOT AN ACCURATE ILLUSTRATION OF REAL TIME CUTS. PLANAR PROBE CHECK IS INDICATING DEEP CUTS ON DISTAL (1.6MM), ANTERIOR(0.5MM), ANTERIOR CHAMFER (0.3MM) AND TIBIA (0.6MM). WHEN TRIAL FEMUR WAS PLACED ONTO BONE THERE IT WAS NOT AN ACCEPTABLE PRESSFIT. THERE WERE GAPS PRESENT BETWEEN THE BONE AND THE TRIAL. DUE TO ERRORS WITH THE CUTS (I.E. CUTS BEING DEEP) MR COLLOPY HAD TO CEMENT THE FEMORAL COMPONENT. SURGICAL DELAY - APPROX. 10MIN. I DO NOT HAVE POST OP X-RAYS BUT I DO HAVE AN IMAGE OF THE PHYSICAL ERRORED CUTS. I DO NOT HAVE ANY FURTHER INFORMATION AFTER THIS. SURGEON WAS UNHAPPY AND NOT COMFORTABLE TO CARRY OUT HIS PREFERENCE OF UNCEMENTED FEMUR - HE CEMENTED THE FEMUR TO MAKE UP WHAT HE STATES ARE UNACCEPTABLE ERROR IN THE CUTS.

    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

    PLANAR PROBE VS BONE MODEL MISMATCH: BONE MODEL VISUAL IS NOT AN ACCURATE ILLUSTRATION OF REAL TIME CUTS. PLANAR PROBE CHECK IS INDICATING DEEP CUTS ON DISTAL (1.6MM), ANTERIOR (0.5MM), ANTERIOR CHAMFER (0.3MM) AND TIBIA (0.6MM). WHEN TRIAL FEMUR WAS PLACED ONTO BONE THERE IT WAS NOT AN ACCEPTABLE PRESSFIT. THERE WERE GAPS PRESENT BETWEEN THE BONE AND THE TRIAL. DUE TO ERRORS WITH THE CUTS (I.E. CUTS BEING DEEP) MR (B)(6) HAD TO CEMENT THE FEMORAL COMPONENT. SURGICAL DELAY: APPROX. 10MIN. I DO NOT HAVE POST OP X-RAYS BUT I DO HAVE AN IMAGE OF THE PHYSICAL "ERRORED" CUTS. I DO NOT HAVE ANY FURTHER INFORMATION AFTER THIS. SURGEON WAS UNHAPPY AND NOT COMFORTABLE TO CARRY OUT HIS PREFERENCE OF UNCEMENTED FEMUR; HE CEMENTED THE FEMUR TO MAKE UP WHAT HE STATES "ARE UNACCEPTABLE ERROR" IN THE CUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912228 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization