BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 7920125 · Received September 28, 2018

    Report

    Report Number
    3005985723-2018-00560
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486001353
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    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. REPORTED EVENT: WHEN REMOVING TIBIAL CHECKPOINT FROM TIBIAL TUBEROSITY, THE CHECKPOINT SNAPPED OFF LEAVING PART OF THE CHECKPOINT IN THE PATIENT. TKA. DEVICE EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT NO W55806 AND ACCEPTED ON 12/14/2017. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 111651, L/N W55806 SHOWS 0 ADDITIONAL COMPLAINTS UNDER INVESTIGATION RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    WHEN REMOVING TIBIAL CHECKPOINT FROM TIBIAL TUBEROSITY, THE CHECKPOINT SNAPPED OFF LEAVING PART OF THE CHECKPOINT IN THE PATIENT. TKA.

    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

    WHEN REMOVING TIBIAL CHECKPOINT FROM TIBIAL TUBEROSITY, THE CHECKPOINT SNAPPED OFF LEAVING PART OF THE CHECKPOINT IN THE PATIENT. TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758498 TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W55806 00848486001353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other