BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6830411 · Received August 30, 2017

    Report

    Report Number
    3005985723-2017-00409
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 29, 2017
    Report Date
    November 28, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 BASED ON THE RESULTS OF INVESTIGATION. "REPORTED EVENT: IT WAS REPORTED THAT THE HANDPIECE HANDLE FELL OFF. ISSUE WAS NOTICED DURING CASE, THEREFOR THERE WAS NO CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K093E AND 24, INCLUDING 4201656, WERE ACCEPTED INTO FINAL STOCK ON 3/15/17. 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 K093E, P/N 209063 SHOWS NO OTHER COMPLAINT 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. FUNCTIONAL INSPECTION: THE HANDPIECE MOTOR AND ELECTRONICS FUNCTION AS INTENDED. CONCLUSIONS: 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 (B)(4) AND CAPA (B)(4) ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT."

    Description of Event or Problem · 1

    MICS HANDLE FELL OFF AND RETAINING SCREW FELL OUT ONTO FLOOR WHILE CUTTING BONE. CASE TYPE TKA.

    Description of Event or Problem · 1

    MICS HANDLE FELL OFF AND RETAINING SCREW FELL OUT ONTO FLOOR WHILE CUTTING BONE. CASE TYPE TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610950 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization