BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8485694 · Received April 4, 2019

    Report

    Report Number
    3005985723-2019-00276
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 19, 2019
    Report Date
    June 18, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: WHILE REAMING THE ACETABULM DURING A MAKO THA, THE LOCK ON THE MICS HANDPIECE BECAME UNLOCKED, WHICH CAUSED THE HANDLE OF THE MICS TO SNAP BACK AT THE DOCTOR. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT NO K070G AND K06UB. 47 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 03/09/2016. REVIEW OF QT16- 03- 0026 REVEALED THAT THE NON CONFORMANCE IS RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N (B)(4)., LOT NUMBER K06UB AND K070G SHOWS 01 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (B)(4). CONCLUSIONS: THE FAILURE MODE WAS DUPLICATED FOR THE ALLEGED FAILURE . NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1429704 AND CAPA 1452931 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    WHILE REAMING THE ACETABULM DURING A MAKO THA, THE LOCK ON THE MICS HANDPIECE BECAME UNLOCKED, WHICH CAUSED THE HANDLE OF THE MICS TO SNAP BACK AT THE DOCTOR. CASE TYPE: THA.

    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

    WHILE REAMING THE ACETABULUM DURING A MAKO THA, THE LOCK ON THE MICS HANDPIECE BECAME UNLOCKED, WHICH CAUSED THE HANDLE OF THE MICS TO SNAP BACK AT THE DOCTOR. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274805 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010216 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization