BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8946792 · Received August 29, 2019

    Report

    Report Number
    3005985723-2019-00625
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 20, 2019
    Report Date
    December 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE. IT WAS REPORTED THAT HANDLE WAS DETACHED FROM MICS. PRODUCT INSPECTION: AS PER SERVICE MAXWO-02012015 & CASE NUMBER (B)(4). RTV DATE: 9/5/2019. LOT # 4201970. SENIOR DEPOT SERVICE TECHNICIAN: (B)(6). RTV REASON: PER D06917, MICS FAILED COLLAR TEST BECAUSE SCREW MISSING FROM HANDLE. THE ALLEGED FAILURE WAS CONFIRMED. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED UNDER LOT K09D0 AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 4/28/17. 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, LOT NUMBER 42040317 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE ALLEGED FAILURE 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

    HANDLE DETACHED FROM MICS. 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

    HANDLE DETACHED FROM MICS. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738884 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42040317 / 4201970 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization