BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9378679 · Received November 26, 2019

    Report

    Report Number
    3005985723-2019-00854
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    February 27, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRIGGER ON MICS IS STICKY AND GETS STUCK MAKING IT VERY DIFFICULT TO ENGAGE HAPTICS AND COMPLETE CUTS. CASE TYPE: TKA. SURGICAL DELAY: YES > 30 MINUTES. PRODUCT INSPECTION AS PER SERVICE MAXWO-01688588 & CASE NUMBER (B)(4) SN # (B)(6). FACTORY SERVICE TECHNICIAN: (B)(6). 1. SUCCESSFULLY PERFORMED MICS CABLE REPLACEMENT PER DO6917. MICS CAN BE RETURNED TO STOCK AS A 209063 LOT #4201501 -R. THE ALLEGED FAILURE WAS CONFIRMED DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER L/N 42021216 AND ALL (B)(4) DEVICES WERE REJECTED ON (B)(6) 2017. A REVIEW OF QT17-01-0035 REVEALED THAT THEY WERE REJECTED DUE TO DOCUMENTATION ISSUE. UNITS WERE ACCEPTED INTO FINAL STOCK AFTER DOCUMENTATION WAS PROVIDED. THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER 42021216 SHOWS 01 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    TRIGGER ON MICS IS STICKY AND GETS STUCK MAKING IT VERY DIFFICULT TO ENGAGE HAPTICS AND COMPLETE CUTS. CASE TYPE: TKA. SURGICAL DELAY: YES > 30 MINUTES.

    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

    TRIGGER ON MICS IS STICKY AND GETS STUCK MAKING IT VERY DIFFICULT TO ENGAGE HAPTICS AND COMPLETE CUTS. CASE TYPE: TKA. SURGICAL DELAY: YES > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169683 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 4201501 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization