BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7134967 · Received December 20, 2017

    Report

    Report Number
    3005985723-2017-00639
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 12, 2017
    Report Date
    March 6, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: THE SCREW IN THE HANDPIECE HANDLE WAS LOOSE/FELL OUT. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K09ZR AND (B)(4) INCLUDING 4202549 WERE ACCEPTED INTO FINAL STOCK ON 8/22/2017. A REVIEW OF (B)(4) SHOWS THAT THE ISSUES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K09ZR, 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. 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. NC/CAPA HISTORY REVIEW 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. TREND #(B)(4)

    Description of Event or Problem · 0

    SET SCREW FELL OUT OF MICS HANDLE CAUSING THE HANDLE TO FALL OFF. TKA CASE DELAYED FOR 5 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

    SET SCREW FELL OUT OF MICS HANDLE CAUSING THE HANDLE TO FALL OFF. TKA CASE DELAYED FOR 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912421 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202549 / 42010717

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization