BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7658494 · Received July 3, 2018

    Report

    Report Number
    3005985723-2018-00398
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 29, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE MANUFACTURER NAME, CITY AND STATE, MFR SITE, DATE REC¿D BY MFR, PMA/510K, IF FOLLOW-UP, WHAT TYPE AND DEVICE EVALUATED BY MFR BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT ONE OF THE SCREWS INSIDE OF THE MICS HANDPIECE CAME OUT. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS LOST AND NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT: K080C AND 23 INCLUDING 4200888 WERE ACCEPTED INTO FINAL STOCK ON 03/09/2017. A REVIEW OF QT17-03-0036 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 209063, PRODEX LOT: K080C SHOWS 01 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT: (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 (B)(4) AND CAPA: 1452931.

    Description of Event or Problem · 0

    ONE OF THE SCREWS INSIDE OF THE MICS HANDPIECE CAME OUT. TKA PROCEDURE DELAYED =15 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

    ONE OF THE SCREWS INSIDE OF THE MICS HANDPIECE CAME OUT. TKA PROCEDURE DELAYED =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501200 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4200888 / 42020716 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization