BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8163875 · Received December 14, 2018

    Report

    Report Number
    3005985723-2018-00750
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    December 6, 2018
    Report Date
    March 22, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT DURING FIRST CUT W RIO, THE SCREW HOLDING THE GRAY PISTOL GRIP TO THE MICS FELL OUT. FIRST ASSIST CAUGHT AND COLLECTED THE SCREW FOR US. THE REST OF THE CUTS WERE COMPLETED PER NORMAL, CASE MOVED ON WITHOUT ANY ISSUES. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. 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 QT 17-02-0049 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 PARTS IN LOT NUMBER K07U2, P/N 209063 SHOWS 02 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (B)(4). CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC (B)(4) AND CAPA 1452931.

    Description of Event or Problem · 0

    TKA. DESCRIPTION - DURING FIRST CUT W RIO, THE SCREW HOLDING THE GRAY PISTOL GRIP TO THE MICS FELL OUT. FIRST ASSIST CAUGHT AND COLLECTED THE SCREW FOR US. THE REST OF THE CUTS WERE COMPLETED PER NORMAL, CASE MOVED ON WITHOUT ANY ISSUES. SURGICAL DELAY MAYBE 30SECS WHILE IT WAS CONFIRMED THE SCREW WAS THE EXACT ONE THAT FELL OUT OF MICS HANDLE.

    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

    TKA. DESCRIPTION - DURING FIRST CUT W RIO, THE SCREW HOLDING THE GRAY PISTOL GRIP TO THE MICS FELL OUT. FIRST ASSIST CAUGHT AND COLLECTED THE SCREW FOR US. THE REST OF THE CUTS WERE COMPLETED PER NORMAL, CASE MOVED ON WITHOUT ANY ISSUES. SURGICAL DELAY MAYBE 30SECS WHILE IT WAS CONFIRMED THE SCREW WAS THE EXACT ONE THAT FELL OUT OF MICS HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006574 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020616/4200801 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization