BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9191241 · Received October 15, 2019

    Report

    Report Number
    3005985723-2019-00733
    Event Type
    Malfunction
    Date Received
    October 15, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. BOLT HEAD SHEARED OFF IN COLLAR. PATIENT WAS UNDER ANESTHESIA. CASE TYPE: TKA. UPDATE: ""IT WAS NOTICED DURING BREAKDOWN OF THE ROBOT AFTER THE CASE."" PRODUCT INSPECTION: MICS-209063 SN#(B)(6). RMA#281100 LOT#42040716 INSPECTED PER D06917 AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.2. VISUAL MISSING SCREWS. DISPOSITION: RTV. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORD INDICATE THAT 25 DEVICES WERE MANUFACTURED UNDER LOT NO K082X AND WERE INSPECTED ALONG WITH 01 DEVICES OF DIFFERENT LOT AND 19 DEVICES OF THE REPORTED LOT AND 01 DEVICE OF DIFFERENT LOT WERE ACCEPTED INTO FINAL STOCK ON 12/13/2016. REVIEW OF QT- 16- 12 - 0040 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 NUMBER 42040716 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: ¿AS PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. 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

    BOLT HEAD SHEARED OFF IN COLLAR. PATIENT WAS UNDER ANESTHESIA. CASE TYPE: TKA. UPDATE: "IT WAS NOTICED DURING BREAKDOWN OF THE ROBOT AFTER THE CASE."

    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

    BOLT HEAD SHEARED OFF IN COLLAR. PATIENT WAS UNDER ANESTHESIA. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984711 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42040716 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization