BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 10993526 · Received December 11, 2020

    Report

    Report Number
    3005985723-2020-00391
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    October 2, 2020
    Report Date
    January 28, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Removal / Correction Number
    Z-0472-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE. ANGLED SAW WOULDN¿T VERIFY. CHANGED ATTACHMENTS. STILL WOULDN¿T VERIFY. CHANGED MICS AND VERIFICATION PASSED. ROBOTIC ARM ALSO STARTED JUMPING AND MAKING A HIGH PITCH SQUEAL WHEN ENTERING HAPTICS ON DISTAL CUT. CHECKED ALL VIZADISCS, CORDS AND CAMERA WERE CLEANED PRIOR TO CASE. CALLED CUSTOMER SUPPORT AND FDE TO REPORT AND REQUEST SERVICE. CASE TYPE / APPLICATION: TKA. SURGICAL DELAY<= 15 MINUTES. PRODUCT INSPECTION. THE FAILURE IS CONFIRMED AS IT IS UNDER THE SCOPE OF NC: MICS CHARACTERIZATION PROCESS DEVIATED FROM THE QUALIFIED STATE. ALSO THE SERIAL NUMBER (B)(6) LIES IN THE URGENT MEDICAL DEVICE RECALL LIST. DEVICE HISTORY REVIEW. DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT 42020715 AND (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/12/2015. REVIEW REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW. A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER4202015 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION. THE ALLEGED FAILURE MODE WAS CONFIRMED DURING INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    ANGLED SAW WOULDN¿T VERIFY. CHANGED ATTACHMENTS. STILL WOULDN¿T VERIFY. CHANGED MICS AND VERIFICATION PASSED. ROBOTIC ARM ALSO STARTED JUMPING AND MAKING A HIGH PITCH SQUEAL WHEN ENTERING HAPTICS ON DISTAL CUT. CHECKED ALL VIZADISCS, CORDS AND CAMERA WERE CLEANED PRIOR TO CASE. CALLED CUSTOMER SUPPORT AND FDE TO REPORT AND REQUEST SERVICE. CASE TYPE / APPLICATION: TKA. SURGICAL DELAY<= 15 MINUTES.

    Additional Manufacturer Narrative · 1

    SERIAL SPECIFIC VOLUNTARY RECALL WAS INITIATED FOR THE MAKO INTEGRATED CUTTING SYSTEM (MICS) WITHIN SCOPE OF A CAPA. THE INITIAL ROOT CAUSE ANALYSIS DETERMINED THAT THE PROCESS FOR CHARACTERIZING MICS HANDPIECES FOR SPECIFIC SERIAL NUMBERS DEVIATED FROM ITS QUALIFIED STATE AT THE TIME OF VALIDATION. THE CAPA INVESTIGATION IS CURRENTLY IN PROGRESS AND AN UPDATED COMMUNICATION WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ANGLED SAW WOULDN¿T VERIFY. CHANGED ATTACHMENTS. STILL WOULDN¿T VERIFY. CHANGED MICS AND VERIFICATION PASSED. ROBOTIC ARM ALSO STARTED JUMPING AND MAKING A HIGH PITCH SQUEAL WHEN ENTERING HAPTICS ON DISTAL CUT. CHECKED ALL VIZADISCS, CORDS AND CAMERA WERE CLEANED PRIOR TO CASE. CALLED CUSTOMER SUPPORT AND FDE TO REPORT AND REQUEST SERVICE. CASE TYPE / APPLICATION: TKA SURGICAL DELAY<= 15 MINUTES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455246 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209063 42020715 / 4200119 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other