BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHELL IMPACTION PLATFORM

    MDR report key: 8889030 · Received August 13, 2019

    Report

    Report Number
    3005985723-2019-00573
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 23, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022082
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS. REPORTED EVENT: IT WAS REPORTED THAT DURING A MAKO THA PROCEDURE, CUP IMPACTION WAS SUCCESSFUL AND COMPLETED. UPON DISMANTLING THE MAKO CUP INSERTER, THE "IMPACTION PLATFORM" WAS CRACKED AND FELL APART UPON REMOVAL FROM THE IMPACTOR SHAFT. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 104 DEVICES WERE MANUFACTURED UNDER LOT: 45010216 AND ACCEPTED INTO FINAL STOCK ON 05/26/2016. NO NON-CONFORMANCE WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 206270, LOT: 45010216 SHOWS 10 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT IS PR 1703282, 1846234, 1868097, 1908295, 1951007, 1996045, 2008507, 2035552, 2082560, 2139541. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NCS OR CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    DURING A MAKO THA PROCEDURE, CUP IMPACTION WAS SUCCESSFUL AND COMPLETED. UPON DISMANTLING THE MAKO CUP INSERTER, THE "IMPACTION PLATFORM" WAS CRACKED AND FELL APART UPON REMOVAL FROM THE IMPACTOR SHAFT. UPDATE: WAS THE PATIENT UNDER ANESTHESIA WHEN THE EVENT OCCURRED? YES. 2. WERE ANY DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT? NO DEBRIS WAS LEFT INSIDE THE PATIENT, SURGEON WAS HAPPY THAT ALL DEBRIS/ PARTS OF THE BROKEN COMPONENT WERE ACCOUNTED FOR. 3. WERE ANY COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED? NO, THE COMPONENT WAS COMPLETE WHEN THE ISSUE OCCURRED.

    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

    DURING A MAKO THA PROCEDURE, CUP IMPACTION WAS SUCCESSFUL AND COMPLETED. UPON DISMANTLING THE MAKO CUP INSERTER, THE "IMPACTION PLATFORM" WAS CRACKED AND FELL APART UPON REMOVAL FROM THE IMPACTOR SHAFT. UPDATE: WAS THE PATIENT UNDER ANESTHESIA WHEN THE EVENT OCCURRED? YES. WERE ANY DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT? NO DEBRIS WAS LEFT INSIDE THE PATIENT, SURGEON WAS HAPPY THAT ALL DEBRIS/ PARTS OF THE BROKEN COMPONENT WERE ACCOUNTED FOR. WERE ANY COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED? NO, THE COMPONENT WAS COMPLETE WHEN THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682222 SHELL IMPACTION PLATFORM STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT# 45010216 00848486022082

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization