BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8709207 · Received June 18, 2019

    Report

    Report Number
    3005985723-2019-00440
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 6, 2019
    Report Date
    October 1, 2019
    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 EVENT: IT WAS REPORTED THAT TRIGGER GETS STUCK WHEN SQUEEZED. PRODUCT EVALUATION AND RESULTS: MICS-209063, SN#: (B)(4), RMA#274571. INSPECTED PER D06917 AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.2. VISUAL STICKY TRIGGER. DISPOSITION: RTV INSPECTED BY: (B)(4). PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0AS4 AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 2/2/2018. A REVIEW OF QT 18-02-0005 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, PRODEX LOT K0AS4 SHOWS 06 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED COMPLAINTS ARE PR 1825632, 1868046, 1897259, 1976851, 2071029, 2116487. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT THERE HAVE BEEN NO NC AND CAPA ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    TRIGGER GETS STUCK WHEN SQUEEZED. CASE TYPE: TKA. UPDATE: "1. DID HANDPIECE RUN WHILE OUTSIDE OF HAPTICS: YES, IT DID."

    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

    TRIGGER GETS STUCK WHEN SQUEEZED. CASE TYPE: TKA. UPDATE: "1. DID HANDPIECE RUN WHILE OUTSIDE OF HAPTICS: YES, IT DID".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503665 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010118 / 4203414 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization