BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 12146784 · Received July 9, 2021

    Report

    Report Number
    3005985723-2021-00127
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 15, 2021
    Report Date
    August 17, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING FOREIGN MATTER INVOLVING A MAKO MICS WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS PRODUCT EVALUATION AND RESULTS: PART# 209063. RMA# 322562 .SN# (B)(6). DEPOT SERVICE TECHNICIAN: (B)(6). HANDLE HAS BEEN DECONTAMINATED AND CLEANSED OF ALL FOREIGN MATERIAL. 1. SUCCESSFULLY PERFORMED INSPECTION. 2. SUCCESSFULLY PERFORMED MICS REPAIR. 3. TESTED PER QIP 0243 TEST PASS SCREEN SHOT. MICS CAN BE RETURNED TO STOCK. MATERIAL ANALYSIS THE FOREIGN DEBRIS ON THE MAKO MICS HANDPIECE WAS ANALYZED USING A FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY)/ATR (ATTENUATED TOTAL REFLECTANCE). THE DEBRIS WAS MATCHED WITH APPROXIMATELY 82%-84% PROBABILITY TO POLYVINYL STEARATE, METHYL LAURATE, OR LAURYL LAURATE. FURTHER ANALYSIS OF MATERIALS USED ON OR WITHIN THE VICINITY OF THE MAKO MICS HANDPIECE DURING ASSEMBLY WOULD BE NECESSARY TO IDENTIFY THE SPECIFIC CAUSE OF THE FOREIGN DEBRIS. -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 4201643, 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: 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 AND PRESENCE OF A FOREIGN MATTER WAS CONFIRMED THROUGH A FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY)/ATR (ATTENUATED TOTAL REFLECTANCE). THE DEBRIS WAS MATCHED WITH APPROXIMATELY 82%-84% PROBABILITY TO POLYVINYL STEARATE, METHYL LAURATE, OR LAURYL LAURATE. THESE COMPONENTS ARE LIKELY RESIDUE FROM SURFACTANTS AND CLEANING AGENTS USED IN THE RE-PROCESSING. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : NOT AVAILABLE.

    Description of Event or Problem · 0

    UNIDENTIFIABLE SUBSTANCE ON MICS HAND PIECE. CASE WAS CANCELLED. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    UNIDENTIFIABLE SUBSTANCE ON MICS HAND PIECE. CASE WAS CANCELLED. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037806 HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209063 42030117 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other