BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7218764 · Received January 25, 2018

    Report

    Report Number
    3005985723-2018-00035
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 19, 2018
    Report Date
    March 7, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    . REPORTED EVENT: THE SCREW IN THE HANDPIECE HANDLE WAS LOOSE/FELL OUT. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED UNDER LOT K09CY AND (B)(4)INCLUDING 4201918 WERE ACCEPTED INTO FINAL STOCK ON 4/17/2017. 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 K09CY, P/N 209063 SHOWS 2 OTHER COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT INVESTIGATION(S): 1637210, 1674841. 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 NC (B)(4) AND CAPA (B)(4) ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT. TREND #(B)(4).

    Description of Event or Problem · 1

    THE SCREW CAME OUT OF THE HANDLE OF THE HANDPIECE. THE SCREW WAS THEN LOST IN PROCESSING. TKA PROCEDURE. THE SCREW WAS FOUND AFTER THE CASE. IT WAS NOT LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    THE SCREW CAME OUT OF THE HANDLE OF THE HANDPIECE. THE SCREW WAS THEN LOST IN PROCESSING. TKA PROCEDURE.THE SCREW WAS FOUND AFTER THE CASE. IT WAS NOT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62351 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4201933 / 42020317

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization