BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6432540 · Received March 24, 2017

    Report

    Report Number
    3005985723-2017-00139
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    March 22, 2017
    Report Date
    August 4, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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: AN EVENT REGARDING AN 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 330 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING AN INACCURATE RESECTION. THERE WERE 9 OTHER REPORTED EVENTS (PR 1178111, 1223927, 1233394, PR1451375, PR1444937, PR 1482645, ACTION 717, ACTION 1068, ACTION 3000). CONCLUSION: THE MAKO SYSTEM PERFORMED WITHIN ITS SPECIFICATION THE USER FAILURE TO SEAT THE MAKO DURING RIO REGISTRATION AND BONE RESECTION WHICH MAY HAVE COMPROMISE THE SYSTEM ACCURACY. THE APPEARANCE OF UNRESECTED BONE IN THE POSTERIOR LATERAL CORNER MAY HAVE OCCURRED IF THE SURGEON DID NOT USE THE RESECTION VIEW BONE PREPARATION STEP FOR THE TIBIAL.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. DURING BURRING OF THE TIBIA SURGEON NOTICED ON THE PLAN THERE WAS STILL POSTERIOR BONE TO BURR, HOWEVER UPON INSPECTION OF POSTERIOR TIBIA THERE WAS NO BONE LEFT TO RESECT AND THE SURGEON WAS BURRING SOFT TISSUE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. DURING BURRING OF THE TIBIA SURGEON NOTICED ON THE PLAN THERE WAS STILL POSTERIOR BONE TO BURR, HOWEVER UPON INSPECTION OF POSTERIOR TIBIA THERE WAS NO BONE LEFT TO RESECT AND THE SURGEON WAS BURRING SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213532 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other