BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHELL IMPACTION PLATFORM

    MDR report key: 8657972 · Received May 31, 2019

    Report

    Report Number
    3005985723-2019-00397
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022082
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT THE END OF THE MAKO STRAIGHT CUP IMPACTOR BROKE OFF INSIDE OF THE IMPACTION PLATFORM. PRODUCT EVALUATION AND RESULTS: AS PER ATTACHED PICTURE THE FAILURE MODE WAS CONFIRMED AS THE PROVIDED PICTURE SHOWS THAT THE END OF STRAIGHT SHELL IMPACTOR BROKE DURING IMPACTION. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 39 DEVICES WERE MANUFACTURED UNDER LOT DM010812 AND 25 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 09/27/12 AND REMAINING 14 DEVICES WERE REJECTED AND PUT IN NPR 12 - 09 - 0026 ON 09/14/12. REVIEW OF NPR 12 - 09 - 0026 REVEALED THAT 10 DEVICES WERE DISPOSITONED AS "USE AS IS" AND ACCEPTED INTO FINAL STOCK ON 01/09/2013 AND REMAINING 03 DEVICES WERE RTV FOR REWORK. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206270, LOT NUMBER DM010812, SHOWS 01 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT ID:1510341. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    THE END OF THE MAKO STRAIGHT CUP IMPACTOR BROKE OFF INSIDE OF THE IMPACTION PLATFORM. CASE TYPE: THA UPDATE: "YES THE IMPACTOR BROKE DURING IMPACTION"

    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

    THE END OF THE MAKO STRAIGHT CUP IMPACTOR BROKE OFF INSIDE OF THE IMPACTION PLATFORM. CASE TYPE: THA. UPDATE: "YES THE IMPACTOR BROKE DURING IMPACTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452232 SHELL IMPACTION PLATFORM STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. DM010812 00848486022082

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization