BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9397407 · Received December 2, 2019

    Report

    Report Number
    3005985723-2019-00892
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 11, 2019
    Report Date
    February 14, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE: THE HANDPIECE WORKED FINE FOR THE CUTS, BUT AFTER THE TRIGGER WAS RELEASED, THE MOTOR CONTINUED RUNNING EVEN THOUGH NO ONE WAS PRESSING IT. CASE TYPE: TKA PER RESPONSE: "YES, IT CONTINUED TO RUN OUTSIDE THE HAPTICS AFTER HE PULLED THE SAW OUT FROM THE CUT." PRODUCT INSPECTION: MICS- 209063 SN#(B)(6); LOT#42080 119; RMA#28439 8; INSPECTED PER (B)(4) AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.2. VISUAL INSPECTION TEST. TRIGGER STUCK. DISPOSITION: RTV INSPECTED BY: (B)(4). DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTUR ED UNDER LOT K0CDW AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 03/25/19. A REVIEW OF QT19-03- 0120 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER420 80119 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.¿ IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. NC/CAPA REVIEW: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    THE HANDPIECE WORKED FINE FOR THE CUTS, BUT AFTER THE TRIGGER WAS RELEASED, THE MOTOR CONTINUED RUNNING EVEN THOUGH NO ONE WAS PRESSING IT. CASE TYPE: TKA. PER RESPONSE: "YES, IT CONTINUED TO RUN OUTSIDE THE HAPTICS AFTER HE PULLED THE SAW OUT FROM THE CUT.".

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    THE HANDPIECE WORKED FINE FOR THE CUTS, BUT AFTER THE TRIGGER WAS RELEASED, THE MOTOR CONTINUED RUNNING EVEN THOUGH NO ONE WAS PRESSING IT. CASE TYPE: TKA. PER RESPONSE: "YES, IT CONTINUED TO RUN OUTSIDE THE HAPTICS AFTER HE PULLED THE SAW OUT FROM THE CUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191578 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42080119SN 4205908 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization