BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO ROBOTIC ARM 3.1

    MDR report key: 16709595 · Received April 10, 2023

    Report

    Report Number
    3005985723-2023-00065
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 20, 2023
    Report Date
    July 11, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    07613327395280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT. AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS. -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. A REQUEST FOR A FIELD SERVICE ENGINEER INSPECTION WAS NOT MADE AND THE ROBOT WAS NOT INSPECTED, HOWEVER A PM WAS COMPLETED ON THE ROBOT AND NO FURTHER ISSUES HAVE BEEN RAISED ON THE COMPLAINTS SYSTEM. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 219999, ROBOT NUMBER: (B)(6) SHOWS OTHER SIMILAR COMPLAINTS FOR ROBOTIC ARM - INACCURATE RESECTION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED AS THERE HAS BEEN NO ONSITE INSPECTION BY A FIELD SERVICE ENGINEER. IF A FIELD SERVICE INSPECTION IS REQUESTED, FURTHER INVESTIGATION WILL BE COMPLETED ON THIS ISSUE. ADDITIONALLY, A COMPLAINT HISTORY REVIEW PROVIDES NO INDICATION OF ANY INHERENT SOFTWARE/ HARDWARE ISSUE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO RED SHOWING ON OUR ANTERIOR CHAMFER CUT AND IT WAS A 3MM GAP. WE CAN NOT FIGURE OUT WHY THIS HAS HAPPENED. AFTER REPLACING OUR ARRAYS WE HAD 5-6 CASES THAT HAD EVEN CUTS-WE ARE NOW BACK TO WHAT IT HAS BEEN.". ROBOT WAS JUST CHECKED BY A FIELD SERVICE TECH AND IT WAS REPORTED BACK THAT EVERYTHING WAS GOOD TO GO. WE ALSO REPLACED ALL ARRAYS AND HANDPIECES IN ORDER TO MAKE SURE WE COVERED OUR BASES. CASE TYPE / APPLICATION: TKA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO RED SHOWING ON OUR ANTERIOR CHAMFER CUT AND IT WAS A 3MM GAP. WE CAN NOT FIGURE OUT WHY THIS HAS HAPPENED. AFTER REPLACING OUR ARRAYS WE HAD 5-6 CASES THAT HAD EVEN CUTS-WE ARE NOW BACK TO WHAT IT HAS BEEN." ROBOT WAS JUST CHECKED BY A FIELD SERVICE TECH AND IT WAS REPORTED BACK THAT EVERYTHING WAS GOOD TO GO. WE ALSO REPLACED ALL ARRAYS AND HANDPIECES IN ORDER TO MAKE SURE WE COVERED OUR BASES. CASE TYPE / APPLICATION: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755710 MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 219999 07613327395280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other