BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 12304629 · Received August 10, 2021

    Report

    Report Number
    3005985723-2021-00137
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 15, 2021
    Report Date
    April 28, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    Removal / Correction Number
    Z-0472-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISASSOCIATION INVOLVING A MAKO MICS WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: HANDPIECE MICS ¿ 209063 ¿ SERIAL#(B)(6), - RMA#324575 INSPECTED AND DETERMINED FAILURE OF THE FOLLOWING TEST STEPS: 7.1.2 HAND PIECE VISUAL INSPECTION . 7.1.4 COLLAR TEST . ORIGINAL DESCRIPTION CONFIRMED. DISPOSITION: RTV - LOOSE SCREW IN COLLAR. INSPECTED BY: SPENCER BARFIELD. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES, INCLUDING SERIAL NUMBER 4200785, WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: 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.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW IT HAS BEEN DETERMINED THAT THIS EVENT IS NOT REPORTABLE. THE AWARENESS DATE OF THIS EVENT IS AFTER THIS DEVICE WAS RECEIVED AND REPAIRED BY THE MANUFACTURER, WHICH MAKES THIS EVENT OUT OF SCOPE OF RECALL Z-0472-2021; THEREFORE, THIS MDR IS BEING CANCELLED. THE EVENT IS COVERED UNDER THE PARTIAL KNEE ARTHROPLASTY MAKO SYSTEM RISK TABLE, HAZARDOUS SITUATION ¿USER IS NOT PROVIDED ADEQUATE INDICATION FOR REGISTRATION CONFIRMATION¿ THAT THE HIGHEST POTENTIAL SEVERITY OF HARM IS S1.

    Description of Event or Problem · 0

    FAILED RIO VERIFICATION. SURGICAL DELAY: = 15 MINUTES. CASE TYPE / APPLICATION: PKA (MICS).

    Description of Event or Problem · 0

    FAILED RIO VERIFICATION. SURGICAL DELAY: = 15 MINUTES. CASE TYPE / APPLICATION: PKA (MICS).

    Additional Manufacturer Narrative · 1

    SERIAL SPECIFIC VOLUNTARY RECALL WAS INITIATED FOR THE MAKO INTEGRATED CUTTING SYSTEM (MICS) WITHIN SCOPE OF A CAPA. THE INITIAL ROOT CAUSE ANALYSIS DETERMINED THAT THE PROCESS FOR CHARACTERIZING MICS HANDPIECES FOR SPECIFIC SERIAL NUMBERS DEVIATED FROM ITS QUALIFIED STATE AT THE TIME OF VALIDATION. THE CAPA INVESTIGATION IS CURRENTLY IN PROGRESS AND AN UPDATED COMMUNICATION WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    FAILED RIO VERIFICATION. SURGICAL DELAY: = 15 MINUTES. CASE TYPE / APPLICATION: PKA (MICS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199577 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209063 42020616 / 4200785 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other