BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7377633 · Received March 28, 2018

    Report

    Report Number
    3005985723-2018-00200
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 23, 2018
    Report Date
    June 28, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE: THE SCREW IN THE HANDPIECE HANDLE WAS LOOSE/FELL OUT. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE(B)(4) WERE MANUFACTURED UNDER LOT K0A8J AND 24 INCLUDING 4202921 WERE ACCEPTED INTO FINAL STOCK ON 10/3/17. A REVIEW OF QT17-10-0006 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, S/N 4202921 IN PRODEX LOT K0A8J SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: THE HANDPIECE MOTOR AND ELECTRONICS FUNCTION AS INTENDED. CONCLUSION: THE SCREW HOLDS THE HANDLE IN PLACE. IF THE SCREW BACKS OUT THEN THE HANDLE CAN FALL.

    Description of Event or Problem · 0

    THE HANDLE ON THE MICS HANDPIECE CAME OFF (THE WHITE PART) DURING BONE PREP. 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

    THE HANDLE ON THE MICS HANDPIECE CAME OFF (THE WHITE PART) DURING BONE PREP. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220772 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202921 / 42050917

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization