BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8134974 · Received December 5, 2018

    Report

    Report Number
    3005985723-2018-00715
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 26, 2018
    Report Date
    August 6, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT WHEN SWAPPING ATTACHMENTS AN INNER RING METAL PIECE FELL OUT FROM INSIDE OF MICS. SWAPPED OUT MICS. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0B9X AND 23 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 8/25/2017. A REVIEW OF QT 18-05-0071 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K0B9X SHOWS 02 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION.COMPLAINT ID:(B)(4). CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION 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 NC1414517 AND CAPA (B)(4).

    Description of Event or Problem · 0

    WHEN SWAPPING ATTACHMENTS AN INNER RING METAL PIECE FELL OUT FROM INSIDE OF MICS. SWAPPED OUT MICS. CASE TYPE: TKA SURGICAL DELAY UNDER FIVE MINUTES.

    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

    WHEN SWAPPING ATTACHMENTS AN INNER RING METAL PIECE FELL OUT FROM INSIDE OF MICS. SWAPPED OUT MICS. CASE TYPE: TKA. SURGICAL DELAY UNDER FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974911 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020518 /4204027 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization