BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 8955801 · Received September 3, 2019

    Report

    Report Number
    3005985723-2019-00636
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 28, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486001353
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: TIBIAL CHECK POINT SHEERED OFF WHEN REMOVING. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 1795 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 10/08/2018. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 111651, L/N W60115-1 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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 NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. PRODUCT WAS NOT AVAILABLE FOR EVALUATION

    Description of Event or Problem · 0

    TIBIAL CHECK POINT SHEERED OFF WHEN REMOVING. CASE TYPE: THA.

    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

    TIBIAL CHECK POINT SHEERED OFF WHEN REMOVING. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751322 TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W60115-1 00848486001353

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization