BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7542919 · Received May 24, 2018

    Report

    Report Number
    3005985723-2018-00308
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    April 25, 2018
    Report Date
    August 1, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE MICS HAD LOW RPM AND TRIGGER STICKING DURING THE CASE. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. NC 1694916 HAS BEEN INITIATED IN REGARDS TO MISSING PRODUCT. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K093A AND 25 INCLUDING 4201652 WERE ACCEPTED INTO FINAL STOCK ON 3/10/2017.NO NON CONFORMANCE WAS IDENTIFIED DURING THE PROCESS. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063,PRODEX LOT K093A SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    WHILE TRYING TO MAKE ANTERIOR CHAMFER CUT THE ARM STARTED TO AGGRESSIVELY VIBRATE AND BOUNCE IN BETWEEN BEING CAUGHT IN THE HAPTICS AND OUT THE HAPTICS. TKA CASE DELAYED UNDER 5 MINUTES. ADDITIONAL INFORMATION PROVIDED: AS PER MPS, THE MICS THAT WAS USED DURING THIS CASE WAS TESTED AND THE MICS HAD A HALL TRIGGER FAILURE. UPDATE: PER THE MPS, THE MICS CONTINUED TO RUN AT HALF SPEED WHILE OUT OF HAPTICS.

    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

    WHILE TRYING TO MAKE ANTERIOR CHAMFER CUT THE ARM STARTED TO AGGRESSIVELY VIBRATE AND BOUNCE IN BETWEEN BEING CAUGHT IN THE HAPTICS AND OUT THE HAPTICS. TKA CASE DELAYED UNDER 5 MINUTES. ADDITIONAL INFORMATION PROVIDED. AS PER MPS, THE MICS THAT WAS USED DURING THIS CASE WAS TESTED AND THE MICS HAD A HALL TRIGGER FAILURE. UPDATE: PER THE MPS, THE MICS CONTINUED TO RUN AT HALF SPEED WHILE OUT OF HAPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384550 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4201652 / 42030117

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization