BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL ARRY, ASSY

    MDR report key: 9104754 · Received September 23, 2019

    Report

    Report Number
    3005985723-2019-00689
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 18, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "AFTER SURGERY WAS COMPLETED, TAKING APART THE FEMORAL ARRAY THE SCRUB TECH AND I NOTICED THE ARRAY ADAPTER AND FEMORAL ARRAY WERE CROSS-THREADED. PATIENT WAS UNDER ANESTHESIA." THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: THE ADAPTER SHOWED SIGNS OF DAMAGE. FUNCTIONAL INSPECTION: THE DEVICE IS NON-FUNCTIONAL. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES 200 DEVICE(S) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09OCT2017 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112240, LOT 19030517 SHOWS 00 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE INVESTIGATION CONCLUDED THAT ALLEGED FAILURE MODE WAS CAUSED BY DAMAGE.

    Description of Event or Problem · 0

    AFTER SURGERY WAS COMPLETED, TAKING APART THE FEMORAL ARRAY THE SCRUB TECH AND I NOTICED THE ARRAY ADAPTER AND FEMORAL ARRAY WERE CROSS-THREADED. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    AFTER SURGERY WAS COMPLETED, TAKING APART THE FEMORAL ARRAY THE SCRUB TECH AND I NOTICED THE ARRAY ADAPTER AND FEMORAL ARRAY WERE CROSS-THREADED. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898120 FEMORAL ARRY, ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19390118

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization