BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 20306268 · Received September 25, 2024

    Report

    Report Number
    3005985723-2024-00167
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 29, 2024
    Report Date
    February 11, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K172219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ROTATING PIECE INSIDE MICS 42131123/4221856 BROKE AND FELL OUT. ALIGNMENT KNOB ON MICS 42080120/4208495 BROKE OFF AND IS MISSING, FSC ERIK RICE RECOMMENDED NOT USING MICS WITHOUT THE KNOB AND HAVE IT TAKEN OUT OF SERVICE. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. 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 HAVE BEEN OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. 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

    ROTATING PIECE INSIDE MICS 42131123/4221856 BROKE AND FELL OUT. ALIGNMENT KNOB ON MICS 42080120/4208495 BROKE OFF AND IS MISSING, FSC RECOMMENDED NOT USING MICS WITHOUT THE KNOB AND HAVE IT TAKEN OUT OF SERVICE. CASE TYPE / APPLICATION: TKA.

    Description of Event or Problem · 0

    ROTATING PIECE INSIDE MICS 42131123/4221856 BROKE AND FELL OUT. ALIGNMENT KNOB ON MICS 42080120/4208495 BROKE OFF AND IS MISSING, FSC RECOMMENDED NOT USING MICS WITHOUT THE KNOB AND HAVE IT TAKEN OUT OF SERVICE. CASE TYPE / APPLICATION: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199241 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 42080120/4208495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other