BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7772482 · Received August 10, 2018

    Report

    Report Number
    3005985723-2018-00477
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED ISSUE HANDPIECE ROTATION RELEASE ON TOP OF POWER SAW, CAME OFF WHEN DR. TRIED TO TURN HANDLE. CASE TYPE: TKA. PRODUCT HISTORY REVIEW DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K076W AND ALL 25 INCLUDING 4200566 WERE ACCEPTED INTO FINAL STOCK ON 4/14/16. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N (B)(4) IN PRODEX LOT K076W SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION VISUAL INSPECTION REVEALED THAT THE HANDLE PIVOT LATCH DISLOCATED FROM THE HANDPIECE. DIMENSIONAL INSPECTION DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL AND FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS MATERIAL ANALYSIS WAS NOT COMPLETED AS VISUAL AND FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION FUNCTIONAL INSPECTION REVEALED THAT THE HANDPIECE HANDLE COULD NOT BECOME UNLOCKED BECAUSE THE LATCH TO UNLOCK THAT FUNCTION HAD DISLOCATED. CONCLUSION IT WAS CONFIRMED THAT THE PIN ATTACHING THE HANDLE PIVOT LATCH TO THE MICS BECAME DISLOCATED.

    Description of Event or Problem · 0

    HANDPIECE ROTATION RELEASE ON TOP OF POWER SAW, CAME OFF WHEN DR. TRIED TO TURN HANDLE. 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

    HANDPIECE ROTATION RELEASE ON TOP OF POWER SAW, CAME OFF WHEN DR. TRIED TO TURN HANDLE. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613924 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020316/ 4200566 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization