BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7239182 · Received February 2, 2018

    Report

    Report Number
    3005985723-2018-00051
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 3, 2018
    Report Date
    April 19, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE MICS WENT DOWN DURING A TKA CASE. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K07GK AND 24 INCLUDING 4200677 WERE ACCEPTED INTO FINAL STOCK ON 6/14/16. REVIEW OF QT16- 06- 0063 REVEALED THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER K07GK SHOWS 03 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THIS COMPLAINTS ARE 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 (B)(4) AND CAPA 1450904.

    Description of Event or Problem · 0

    MAKO MICS HANDPIECE BROKE TOWARDS END OF CASE. SURGEON ABLE TO COMPLETE SURGERY WITHOUT IMPACT ON PATIENT OR TIME.

    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

    MAKO MICS HANDPIECE BROKE TOWARDS END OF CASE. SURGEON ABLE TO COMPLETE SURGERY WITHOUT IMPACT ON PATIENT OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79733 HANDPIECE MICS STEREOTACTIC DEVICE, INSTRUMENT OLO MAKO SURGICAL CORP. 4200677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other