BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKOPLASTY® PARTIAL KNEE END EFFECTOR

    MDR report key: 7404306 · Received April 6, 2018

    Report

    Report Number
    3005985723-2018-00222
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 27, 2018
    Report Date
    May 23, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: THE EVENT REPORTED THAT A PARTIAL KNEE END EFFECTOR'S MAGNET WAS FOUND MISSING FROM THE TRIGGER. A DELAY OF 5 MINUTES OCCURRED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS THAT THE MAGNET WAS MISSING FROM THE TRIGGER. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS SHOW THAT 62 OF 63 DEVICE WERE ACCEPTED INTO FINAL STOCK ON 07/12/2016 WITH NO REPORTED DISCREPANCIES. NPR- QT16-07-0026 PERTAINED TO S/N 1900994 FOR LOGO / MARKING LEGIBILITY AND THE PART WAS DISPOSITIONED FOR SCRAP ON 07/13/2016. THIS NONCONFORMANCE WAS UNRELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINTS HISTORY REVIEW: REVIEW OF COMPLAINTS FOR P/N 111758, L/N 19470615 WITHIN THE TRACKWISE DATABASE SHOW SEVEN (7) OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS COMPLAINT. THE PR'S ARE (B)(4). CONCLUSION: THE FAILURE WAS CONFIRMED. CORRECTIVE ACTION / PREVENTIVE ACTION: NC 1454143 HAS BEEN CLOSED FOR THE FAILURE MODE OF MAGNET DISASSOCIATION EXCEEDING THE ACCEPTABLE OCCURRENCE RATE. CAPA 1454425 HAS BEEN INITIATED FOR THE FAILURE MODE.

    Description of Event or Problem · 0

    ANSPACH FAILURE (SECOND PKA OF DAY). ANSPACH WOULDN'T PASS BURR STATUS CHECK PREOPERATIVELY BUT IT PASSED THE FOOT PEDAL TEST PREOPERATIVELY. INTRAOP WE TRIED TO USE THE TRIGGER HANDPIECE AND IT WOULDN'T POWER THE BURR. WE RESET THE CUTTER AND ENDED UP HAVING TO DO BURR OVERRIDE FOR THIS CASE AS WELL AND THE FOOT PEDAL WORKED TO FINISH THE CASE. SURGICAL DELAY OF 5 MINUTES. ADDITIONAL INFORMATION PROVIDED: AFTER CASE WE FOUND MAGNET MISSING ON END EFFECTOR. PR WAS UPDATED TO THE END EFFECTOR.

    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

    ANSPACH FAILURE (SECOND PKA OF DAY). ANSPACH WOULDN'T PASS BURR STATUS CHECK PREOPERATIVELY BUT IT PASSED THE FOOT PEDAL TEST PREOPERATIVELY. INTRAOP WE TRIED TO USE THE TRIGGER HANDPIECE AND IT WOULDN'T POWER THE BURR. WE RESET THE CUTTER AND ENDED UP HAVING TO DO BURR OVERRIDE FOR THIS CASE AS WELL AND THE FOOT PEDAL WORKED TO FINISH THE CASE. SURGICAL DELAY OF 5 MINUTES. AFTER CASE WE FOUND MAGNET MISSING ON END EFFECTOR. PR WAS UPDATED TO THE END EFFECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245079 MAKOPLASTY® PARTIAL KNEE END EFFECTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 1901012

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization