BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO ROBOTIC ARM - MICS

    MDR report key: 9165870 · Received October 8, 2019

    Report

    Report Number
    3005985723-2019-00723
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 30, 2019
    Report Date
    June 17, 2020
    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

    UPDATE TO B2 AND D2. REPORTED EVENT: IT WAS REPORTED THAT MICS FAILED INTRA-OP AND THEN FAILED MICS STATUS CHECK POST-OP. CASE TYPE: TKA SURGICAL DELAY: 30 MINUTES UPDATE: "WE HAD ONE REPLACEMENT AND IT ALSO FAILED. WE HAD TO COMPLETE OUR FINAL RECUT MANUALLY." PRODUCT EVALUATION AND RESULTS: MICS-209063 SN# (B)(6) LOT#42060618 PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED AND ALL 25 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 07/13/2018. NO NON-CONFORMANCE WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT 42060618 SHOWS 7 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE IS CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    MICS FAILED INTRA-OP AND THEN FAILED MICS STATUS CHECK POST-OP. CASE TYPE: TKA SURGICAL DELAY: 30 MINUTES. RELATED PI 2202453. UPDATE: "WE HAD ONE REPLACEMENT AND IT ALSO FAILED. WE HAD TO COMPLETE OUR FINAL RECUT MANUALLY."

    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

    MICS FAILED INTRA-OP AND THEN FAILED MICS STATUS CHECK POST-OP. CASE TYPE: TKA. SURGICAL DELAY: 30 MINUTES RELATED PI (B)(4). UPDATE: "WE HAD ONE REPLACEMENT AND IT ALSO FAILED. WE HAD TO COMPLETE OUR FINAL RECUT MANUALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960630 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O