BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9119593 · Received September 25, 2019

    Report

    Report Number
    3005985723-2019-00695
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 23, 2019
    Report Date
    January 21, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN PERFORMING OUR INITIAL RESECTION CUT, THE MICS POWER STOPPED WORKING MID CUT AS IF IT LOST POWER. AS NEW MICS HAND PIECE WAS BEING CHANGED, A ROTATIONAL BOLT FELL OUT OF THE OPENING OF THE HAND PIECE. CASE TYPE: TKA. INTRA OP DELAY OF 4 MINS. PRODUCT INSPECTION: MICS-209063, SN# (B)(6), LOT#42030218, RMA#281028. INSPECTED PER (B)(4) AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.4: FAILED COLLAR TEST. DISPOSITION: RTV. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K0AWU AND (B)(4)DEVICES WERE ACCEPTED INTO FINAL STOCK ON 03/08/2018. A REVIEW OF QT18-03-0020 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, LOT NUMBER 42030218 SHOWS 6 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE ALLEGED FAILURE MODE WAS CONFIRMED. 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

    WHEN PERFORMING OUR INITIAL RESECTION CUT, THE MICS POWER STOPPED WORKING MID CUT AS IF IT LOST POWER. AS NEW MICS HAND PIECE WAS BEING CHANGED, A ROTATIONAL BOLT FELL OUT OF THE OPENING OF THE HAND PIECE. CASE TYPE: TKA. INTRA OP DELAY OF 4 MINS.

    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

    WHEN PERFORMING OUR INITIAL RESECTION CUT, THE MICS POWER STOPPED WORKING MID CUT AS IF IT LOST POWER. AS NEW MICS HAND PIECE WAS BEING CHANGED, A ROTATIONAL BOLT FELL OUT OF THE OPENING OF THE HAND PIECE. CASE TYPE: TKA. INTRA OP DELAY OF 4 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914476 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42030218 / 4203617 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization