BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8134982 · Received December 5, 2018

    Report

    Report Number
    3005985723-2018-00714
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 5, 2018
    Report Date
    August 2, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: (B)(4): MPS (B)(6) REPORTED ACCURACY ISSUES DURING SURGERY. TKA-SURGEON REPORTED FEMUR NOTCHING. RESOLUTION: CALL WAS FOR ACCURACY ISSUE DURING CASE, ARM ACCURACY FAILED SO PERFORMED KIN-KAL AND THEN PASSED ARM ACCURACY. APPROXIMATELY 2MM NOTCH. NOTICED BY SURGEON DURING ANTERIOR CUT. DEVICE EVALUATION AND RESULTS: PER (B)(4)- CALL WAS FOR ACCURACY ISSUE DURING CASE, ARM ACCURACY FAILED SO PERFORMED KIN-KAL AND THEN PASSED ARM ACCURACY. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 04/17/2017. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW : A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209999 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    (B)(4): MPS (B)(6) REPORTED ACCURACY ISSUES DURING SURGERY. TKA-SURGEON REPORTED FEMUR NOTCHING. RESOLUTION: CALL WAS FOR ACCURACY ISSUE DURING CASE, ARM ACCURACY FAILED SO PERFORMED KIN-KAL AND THEN PASSED ARM ACCURACY APPROXIMATELY 2MM NOTCH NOTICE BY SURGEON DURING ANTERIOR CUT.

    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

    (B)(4): MPS (B)(6) REPORTED ACCURACY ISSUES DURING SURGERY. TKA: SURGEON REPORTED FEMUR NOTCHING. RESOLUTION: CALL WAS FOR ACCURACY ISSUE DURING CASE, ARM ACCURACY FAILED SO PERFORMED KIN-KAL AND THEN PASSED ARM ACCURACY. APPROXIMATELY 2MM NOTCH. NOTICE BY SURGEON DURING ANTERIOR CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974915 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization