BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6444210 · Received March 29, 2017

    Report

    Report Number
    3005985723-2017-00157
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    February 21, 2017
    Report Date
    July 24, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING INCORRECT VERSION INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 332 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING INCORRECT VERSION. THERE WERE 12 OTHER REPORTED EVENTS (PR1044925, 1219418, 1233394, 1260347, 1260393, 1260426, 1260427, 1260480, 1325106, PR1354370, PR1418263). CONCLUSION: THERE IS NO DATA IN THE SEGMENTATION, WORK FLOW, WARNINGS & ERRORS, CT LANDMARKS, RIO REGISTRATION, BONE REGISTRATION, PROBE CHECK, IMPLANT PLANNING, REAMING AND IMPACTION CHECKPOINTS, NUMBER OF END EFFECTORS USED, IMPLANT PLANNING, AND RESECTION VIEW TO INDICATE A SYSTEM MALFUNCTION. AN X-RAY ANALYSIS WAS PERFORMED BY DR. (B)(6). THE RESULTS FROM HIS ANALYSIS ARE AS FOLLOWS: CONFERENCE CALL WITH DR. (B)(6) (B)(6) 2017: DR. (B)(6) COULD NOT DETERMINE VERSION FROM 1 X-RAY, WOULD NEED CT SCAN, CLINICAL DATA, MEDICAL HISTORY, AGE, WEIGHT, HEIGHT, AND BMI (NONE OF WHICH IS AVAILABLE, SEE COMMUNICATION DETAILS ABOVE) TO DIRECTLY MEASURE THE VERSION AND MORE INTENSIVE X-RAYS. FROM X-RAY CAN ONLY TELL THAT THE RIGHT HIP IS SLIGHTLY MORE VERTICAL THAN THE LEFT. HOWEVER, IF THE PATIENT WAS STABLE ONCE WAKING FROM ANAESTHESIA, THE HIP WOULD NOT BE AT RISK. AFTER SPEAKING WITH THE REP, IT HAS BEEN CONCLUDED THAT HE DOES NOT HAVE ACCESS TO PATIENT DEMOGRAPHICS AND CANNOT PROVIDE ANY CLINICAL DATA OR MEDICAL HISTORY. HE DID SAY THAT THE SURGEON ONLY TOOK A POST OP X-RAY AND DID NOT TAKE A CT SCAN. THE DATA AT THIS TIME SHOWS THE MAKO OPERATED AS EXPECTED. NO SYSTEM DEFECT OR MALFUNCTION IS SUSPECTED.

    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 COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE VERSION ON THE ROBOT IS DIFFERENT THAN THE POST OP X-RAY. SAYS THE POST OP IS MORE VERTICAL (10-15 DEGREES) THAN WHAT THE ROBOT WAS SUPPOSED TO PUT IT IN.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE VERSION ON THE ROBOT IS DIFFERENT THAN THE POST OP X-RAY. SAYS THE POST OP IS MORE VERTICAL (10-15 DEGREES) THAN WHAT THE ROBOT WAS SUPPOSED TO PUT IT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225624 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1