BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9227696 · Received October 23, 2019

    Report

    Report Number
    3005985723-2019-00752
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 28, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRIGGER TO UNLOCK HANDLE TO ROTATE, THE PIN FELL OUT. HANDLE LOCKED IN PLACE. CANNOT SEE LOT NUMBER BECAUSE OF THAT. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES. PRODUCT EVALUATION AND RESULTS: MICS-209063, SN# (B)(6), RMA#282620. INSPECTED PER D06917 AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.2. VISUAL PIVOT HANDLE. THE PIVOT HANDLE LOCK WAS BROKEN OFF COULD NOT ROTATE BUT I WAS ABLE TO VERIFY THE SN# (B)(6). DISPOSITION: RTV INSPECTED BY: (B)(6). PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT 42040317 AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 28 APRIL, 2017. A REVIEW OF QT17-04-0080 REVEALED THAT THE ISSUE 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, L/N: 42040317 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    TRIGGER TO UNLOCK HANDLE TO ROTATE, THE PIN FELL OUT. HANDLE LOCKED IN PLACE. CANNOT SEE LOT NUMBER BECAUSE OF THAT. CASE TYPE: TKA. SURGICAL DELAY: =15 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 TO UNLOCK HANDLE TO ROTATE, THE PIN FELL OUT. HANDLE LOCKED IN PLACE. CANNOT SEE LOT NUMBER BECAUSE OF THAT. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020864 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42040317 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization