BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7321178 · Received March 7, 2018

    Report

    Report Number
    3005985723-2018-00143
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 19, 2018
    Report Date
    April 30, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. "REPORTED ISSUE: THE SCREW IN THE HANDPIECE HANDLE WAS LOOSE/FELL OUT. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K09CY AND (B)(4) INCLUDING 4201938 WERE ACCEPTED INTO FINAL STOCK ON 4/17/2017. A REVIEW OF (B)(4) 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 (B)(4) SHOWS 0 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: 0. 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 · 1

    THE SET SCREW AT THE BOTTOM OF THE MICS HANDLE FELL OUT WHILE CUTTING FEMUR. TKA PROCEDURE. AS REPORTED BY THE (B)(6): THE SCREW WAS FOUND ON SURGICAL FIELD.

    Description of Event or Problem · 1

    THE SET SCREW AT THE BOTTOM OF THE MICS HANDLE FELL OUT WHILE CUTTING FEMUR. TKA PROCEDURE. AS REPORTED BY THE MPS: THE SCREW WAS FOUND ON SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164716 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4201938 / 42020317

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization