BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7377057 · Received March 28, 2018

    Report

    Report Number
    3005985723-2018-00193
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 27, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED ISSUE: THE HANDPIECE DID NOT WORK. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K07V3 AND 25 INCLUDING 4200805 WERE ACCEPTED INTO FINAL STOCK ON 7/30/16. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N (B)(4) IN PRODEX LOT K07V3 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND FAILED. THE MOTOR DID NOT SPIN DURING THE TEST. SCREENSHOT IS ATTACHED. CONCLUSION: THE HANDPIECE DRIVER ELECTRONICS (COMMUTATION BOARD) COMMUNICATES WITH THE HANDPIECE TRIGGER. A FAILURE OF THIS COMMUNICATION WILL BREAK THE PROCESS THAT ALLOWS THE TRIGGER COMMAND TO RESULT IN THE MOTOR SPINNING.

    Description of Event or Problem · 0

    ROBOT STOPPED WORKING DURING INITIAL CUT. TKA CASE DELAYED FOR 10 MINUTES. WAS THE CASE COMPLETED MANUALLY? YES.

    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

    ROBOT STOPPED WORKING DURING INITIAL CUT. TKA CASE DELAYED FOR 10 MINUTES. WAS THE CASE COMPLETED MANUALLY? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220744 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010716

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization