BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8545723 · Received April 24, 2019

    Report

    Report Number
    3005985723-2019-00314
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 26, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: STRYKER REP REPORTED THAT THE SCREW FELL OUT WHEN THE MICS HAND PIECE WAS REMOVED FROM THE ROBOTIC ARM. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. FROM THE PHOTOGRAPHS PROVIDED THERE IS EVIDENCE THAT THE SCREW IS MISSING FROM THE MICS HAND PIECE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT PERFORMED AS VISUAL INSPECTION CONFIRMED THE FAILURE. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09Q7 AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2017. REVIEW OF QT17 - 06 - 0068 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS UNKNOWN. 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 THAT NC 1429704 AND CAPA 1452931 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    STRYKER REP REPORTED THAT THE SCREW FELL OUT WHEN THE MICS HAND PIECE WAS REMOVED FROM THE ROBOTIC ARM. UPDATE: WE WERE NOT DISASSEMBLING THE MICS FROM THE ROBOT, IT FELL OUT WHEN THE CUTS WERE BEING MADE.

    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

    STRYKER REP REPORTED THAT THE SCREW FELL OUT WHEN THE MICS HAND PIECE WAS REMOVED FROM THE ROBOTIC ARM. UPDATE: WE WERE NOT DISASSEMBLING THE MICS FROM THE ROBOT, IT FELL OUT WHEN THE CUTS WERE BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339065 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202288 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization