BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL ARRAY POST ASSEMBLY

    MDR report key: 9722488 · Received February 18, 2020

    Report

    Report Number
    3005985723-2020-00092
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 23, 2020
    Report Date
    April 22, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486003142
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: PIN OF END EFFECTOR ATTACHMENT BROKE. PRODUCT EVALUATION AND RESULTS: AS PER THE IMAGE PROVIDED IN THE COMMUNICATION LOG , THE BROKEN CROSS PIN CAN BE SEEN AND CONFIRMED, THOUGH THE DEVICE HAS NOT BEEN RETURNED FOR INSPECTION. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND 30 WERE REJECTED ON 01/21/2019. A REVIEW OF QT19 - 01- 0072 REVEALED THAT THE NON- CONFORMANCE WAS RELATED TO THE WRONG BAR CODE . A REVIEW OF QT19 - 01- 0072 REVEALED THAT THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THE COMPLAINT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND 66 WERE REJECTED ON 07/14/2019. A REVIEW OF QT19 - 08- 0058 REVEALED THAT ALL THE DEVICES WERE ACCEPTED TO BE USE AS IS ON 08/16/2019 . A REVIEW OF QT19 - 08- 0058 REVEALED THAT THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THE COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 160245, L/N W60290 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD BE DETERMINED VIA VISUAL INSPECTION OF THE IMAGE PROVIDED IN THE COMMUNICATION LOG. 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 NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    PIN OF END EFFECTOR ATTACHMENT BROKE. CASE TYPE: THA. SURGICAL DELAY : <= 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

    PIN OF END EFFECTOR ATTACHMENT BROKE. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186081 FEMORAL ARRAY POST ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 160245 W60290 00848486003142

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization