BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7404312 · Received April 6, 2018

    Report

    Report Number
    3005985723-2018-00220
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 15, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE: THE HANDPIECE HAD A STUCK TRIGGER. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED UNDER LOT K06LC AND (B)(4) INCLUDING 4200386 WERE ACCEPTED INTO FINAL STOCK ON 2/2/16. 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)(6) IN PRODEX LOT K06LC SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION: VISUAL INSPECTION SHOWS THE TRIGGER IS BINDING AND NOT ALLOWING THE TRIGGER TO FULLY RELEASE TO THE START POSITION. THE TRIGGER IS ABLE TO BE PULLED/FORCED TO THE START (FULLY RELEASED) POSITION. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL AND FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION SHOWS THE HANDPIECE DOES NOT OPERATE WHEN THE TRIGGER IS IN THE BINDING STATE, SO THE COMPLAINT IS CONFIRMED. WHEN THE TRIGGER IS PULLED/ FORCED TO THE START (FULLY RELEASED) POSITION THE HANDPIECE STARTS AND ACCELERATES AS THE TRIGGER IS SQUEEZED. AFTER RELEASE OF THE TRIGGER, THE TRIGGER DOES NOT FULLY RELEASE. THE MOTOR CONTINUES TO SLOWLY TURN AS WOULD BE EXPECTED WITH A SLIGHTLY PRESSED TRIGGER. THE MOTOR SHUTS OFF WHEN THE TRIGGER IS PULLED/FORCED TO THE FULLY RELEASED POSITION. CONCLUSION: THE SYSTEM WILL NOT SPIN THE MOTOR IF THE HANDPIECE IS INITIALIZED WITH A PARTIALLY DEPRESSED TRIGGER. A BINDED TRIGGER LOOKS TO THE SYSTEM AS A PARTIALLY DEPRESSED TRIGGER. THE TRIGGER STICKS BECAUSE THE TRIGGER SHAFT IS MADE OF TWO COLLINEAR SHAFTS. THE JUNCTION OF THESE 2 SHAFTS SLIDES THROUGH A BORE. MISALIGNMENT OF THE 2 SHAFTS CAUSES THE TRIGGER TO BIND WHEN THE JUNCTION SLIDES THROUGH THE BORE.

    Description of Event or Problem · 0

    MICS TRIGGER MALFUNCTION. TKA CASE DELAYED 15 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

    MICS TRIGGER MALFUNCTION. TKA CASE DELAYED 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245256 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4200386 / 42020217

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization