BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 16159360 · Received January 13, 2023

    Report

    Report Number
    3005985723-2023-00007
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 30, 2022
    Report Date
    April 28, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Removal / Correction Number
    Z-0472-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING REGISTRATION FAILS INVOLVING A MAKO MICS WAS REPORTED. THE EVENT WAS NOT CONFIRMED HOWEVER THE SERIAL NUMBER FALLS WITHIN THE SCOPE OF Z-0472-2021. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: HANDPIECE MICS ¿ (B)(4)¿ SERIAL# (B)(6). INSPECTED AND UNABLE TO DETERMINE ORIGINAL COMPLAINT. ORIGINAL DESCRIPTION NOT CONFIRMED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE ARE OTHER COMPLAINTS WITH A SIMILAR FAILURE MODE FOR THIS LOT. CONCLUSIONS: THE ALLEGED FAILURE WAS NOT CONFIRMED WITH THE AVAILABLE TESTING METHODS; HOWEVER, THE DEVICE FALLS UNDER THE SCOPE OF Z-0472-2021 WHICH IS LINKED WITH REGISTRATION ISSUES DUE TO THE CHARACTERIZATION PROCESS. 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 TOTAL 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.

    Additional Manufacturer Narrative · 0

    AS PART OF 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. 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 · 0

    THE MICS WOULD PASS MICS STATUS CHECK HOWEVER FAILED DURING RIO REGISTRATION IN PRE-SURGERY CHECKS. CASE TYPE / APPLICATION: TKA.

    Description of Event or Problem · 0

    THE MICS WOULD PASS MICS STATUS CHECK HOWEVER FAILED DURING RIO REGISTRATION IN PRE-SURGERY CHECKS. CASE TYPE / APPLICATION: TKA.

    Description of Event or Problem · 0

    THE MICS WOULD PASS MICS STATUS CHECK HOWEVER FAILED DURING RIO REGISTRATION IN PRE-SURGERY CHECKS. CASE TYPE / APPLICATION: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019266 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209063 42100520 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other