BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7077866 · Received December 2, 2017

    Report

    Report Number
    3005985723-2017-00599
    Event Type
    Malfunction
    Date Received
    December 2, 2017
    Date of Event
    November 17, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. IT WAS REPORTED THAT THE HANDLE FELL OFF. ISSUE WAS NOTICED DURING CASE, THEREFOR THERE WAS NO CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K07V8 AND 24 INCLUDING 4200846 WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2016. 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 PARTS IN LOT NUMBER K07V8, P/N 209063 SHOWS 1 OTHER COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT INVESTIGATIONS ARE: (B)(4). MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE FUNCTIONAL INSPECTION CLEARLY SHOWED FAILURE. VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT. DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. THE HANDPIECE MOTOR AND ELECTRONICS FUNCTION AS INTENDED. THE SCREW HOLDS THE HANDLE IN PLACE. IF THE SCREW BACKS OUT THEN THE HANDLE CAN FALL. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC1429704 AND (B)(4) ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT."

    Description of Event or Problem · 1

    THE GREY HANDLE CAME LOOSE AND FELL TO THE GROUND AFTER FINISHING THE TIBIA CUT. TKA CASE.

    Description of Event or Problem · 1

    THE GREY HANDLE CAME LOOSE AND FELL TO THE GROUND AFTER FINISHING THE TIBIA CUT. TKA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857037 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization