BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8795639 · Received July 16, 2019

    Report

    Report Number
    3005985723-2019-00520
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 10, 2019
    Report Date
    September 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: MICS HANDPIECE HANDLE FELL OFF DURING THE PROCEDURE. THE SCREW DROPPED OUT AND THE GREY PART OF THE HANDLE SLID OFF OF THE MAIN PORTION. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THE HANDLE FELL OFF DURING THE PROCEDURE. THE SCREW DROPPED OUT AND THE GREY PART OF THE HANDLE SLID OFF THE MAIN PORTION ATTEMPTS TO REPAIR WERE UNSUCCESSFUL. MICS FAILED VISUAL INSPECTION, HANDLE CRACKED. FUNCTIONAL INSPECTION, DIMENSIONAL INSPECTION AND MATERIAL ANALYSIS. ANALYSIS WERE NOT PERFORMED AS VISUAL INSPECTION CONFIRMED THE FAILURE. PER WO-01916043 AND 03909372, PART WAS RTV FOR REWORK. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT: K078L AND 18 INCLUDING 4200599 WERE ACCEPTED INTO FINAL STOCK ON 5/16/2016.REVIEW OF QT16 - 05 - 0060 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER: K078L, P/N: 209063 SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. 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

    MICS HANDPIECE HANDLE FELL OFF DURING THE PROCEDURE. THE SCREW DROPPED OUT AND THE GREY PART OF THE HANDLE SLID OFF OF THE MAIN PORTION. CASE TYPE: TKA.

    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

    MICS HANDPIECE HANDLE FELL OFF DURING THE PROCEDURE. THE SCREW DROPPED OUT AND THE GREY PART OF THE HANDLE SLID OFF OF THE MAIN PORTION. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589861 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42030316 / 4200586 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization