BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7572833 · Received June 6, 2018

    Report

    Report Number
    3005985723-2018-00342
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 11, 2018
    Report Date
    August 1, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE: SCREW FELL OUT OF HANDLE ON HANDPIECE WHEN DOCTOR WAS DONE MAKING CUTS. WHEN ROBOT WAS MOVED INTO HOLSTER POSITION. TKA CASE. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 20 DEVICES WERE MANUFACTURED UNDER LOT K05AF AND 19 INCLUDING 4200107 WERE ACCEPTED INTO FINAL STOCK ON 8/12/2015. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N (B)(4) IN PRODEX LOT K05AF 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

    SCREW FELL OUT OF HANDLE ON HANDPIECE WHEN DOCTOR WAS DONE MAKING CUTS. WHEN ROBOT WAS MOVED INTO HOLSTER POSITION. TKA CASE.

    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

    SCREW FEEL OUT OF HANDLE ON HANDPIECE WHEN DOCTOR WAS DONE MAKING CUTS. WHEN ROBOT WAS MOVED INTO HOLSTER POSITION. TKA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415310 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4200107 / 42020715 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization