BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7572816 · Received June 6, 2018

    Report

    Report Number
    3005985723-2018-00338
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 18, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT THE MICS HANDLE FELL DURING THE CASE. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K07GK AND (B)(4) INCLUDING 4200667 WERE ACCEPTED INTO FINAL STOCK ON 6/14/16. REVIEW OF QT16-06-0063 REVEALED THAT THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER 42030416 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE WAS CONFIRMED BASED ON THE PICTURES PROVIDED THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC (B)(4) AND CAPA (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    SURGEON PLACED MICS BACK IN HOLSTER POSITION. HANDLE AND SCREW FELL OUT. SURGICAL DELAY APPROXIMATELY 15 MINUTES. MICS HANDPIECE REPLACED. TKA PROCEDURE.

    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

    SURGEON PLACED MICS BACK IN HOLSTER POSITION. HANDLE AND SCREW FELL OUT. SURGICAL DELAY APPROXIMATELY 15 MINUTES. MICS HANDPIECE REPLACED. TKA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414947 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 420304164200667 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization