BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8398719 · Received March 7, 2019

    Report

    Report Number
    3005985723-2019-00213
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 26, 2019
    Report Date
    June 18, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT DURING 6TH CUT (TIBIA) THE MICS HANDPIECE FELL APART. THE PIECE THAT COMES OUT OF THE MOUTH OF THE MICS THAT HOLDS THE SAW ATTACHMENT DETACHED DURING THE CUT. THE DOCTOR HAD TO STOP HIS CUTS AS WE CHANGED OUT THE MICS FOR A NEW ONE. THERE ARE LITTLE BEADS THAT FELL OUT OF THE INSIDE OF THE MICS. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMED THAT THE COLLAR WAS BROKEN. ATTEMPTS TO REPAIR THE DEVICE WERE UNSUCCESSFUL AND THE PART WAS RTV FOR REWORK. FUNCTIONAL, DIMENSIONAL AND MATERIAL ANALYSIS INSPECTION WERE NOT PERFORMED AS VISUAL INSPECTION CONFIRMED THE FAILURE. AS PER (B)(4) AND CASE NUMBER (B)(4). FAILURE MODE WAS DUPLICATED AND PRODUCT WAS RETURNED TO VENDOR. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K07U2. A REVIEW OF QT16-07-0090 SHOWS THAT THESE PARTS INITIALLY FAILED DUE TO NO CHARACTERIZATION DATA. DATA WAS LOADED AND THE UNITS WERE RE-INSPECTED ON 2/14/2017 AND PUT ON (B)(4) FOR MISSING DOCUMENTATION. THIS UNIT WAS ACCEPTED INTO INVENTORY WHEN MISSING DOCUMENTS WERE PROVIDED. THE ISSUES WERE NOT RELATED TO THE COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N (B)(4) IN PRODEX LOT K07U2 SHOWS 06 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (B)(4). CONCLUSIONS: THE FAILURE MODE WAS DUPLICATED FOR THE ALLEGED FAILURE. ATTEMPTS TO REPAIR WERE UNSUCCESSFUL AND THE PART WAS RTV FOR REWORK. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC (B)(4) AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    AS REPORTED: "DURING 6TH CUT (TIBIA) THE MICS HANDPIECE FELL APART. THE PIECE THAT COMES OUT OF THE MOUTH OF THE MICS THAT HOLDS THE SAW ATTACHMENT DETACHED DURING THE CUT. THE DOCTOR HAD TO STOP HIS CUTS AS WE CHANGED OUT THE MICS FOR A NEW ONE. THERE ARE LITTLE BEADS THAT FELL OUT OF THE INSIDE OF THE MICS." EVENT TOOK PLACE "DURING THE TIBIA CUT". A 5 MINUTE SURGICAL DELAY WAS REPORTED. 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

    AS REPORTED: "DURING 6TH CUT (TIBIA) THE MICS HANDPIECE FELL APART. THE PIECE THAT COMES OUT OF THE MOUTH OF THE MICS THAT HOLDS THE SAW ATTACHMENT DETACHED DURING THE CUT. THE DOCTOR HAD TO STOP HIS CUTS AS WE CHANGED OUT THE MICS FOR A NEW ONE. THERE ARE LITTLE BEADS THAT FELL OUT OF THE INSIDE OF THE MICS". EVENT TOOK PLACE "DURING THE TIBIA CUT". A 5 MINUTE SURGICAL DELAY WAS REPORTED. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192761 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020616 / 4200791 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization