BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 9654852 · Received January 31, 2020

    Report

    Report Number
    3005985723-2020-00065
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    December 10, 2019
    Report Date
    April 22, 2020
    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

    REPORTED EVENT: TIBIA CHECKPOINT WAS LEFT IN PATIENT. CHECKPOINT BECAME DISLODGED DURING TEAMING AND FELL INTO BONY DEFECT IN ACETABULUM AND COULD NOT BE RECOVERED. CASE TYPE: THA. SURGICAL DELAY : 16-30 MINUTES. PRODUCT EVALUATION AND RESULTS: AS PER THE X-RAY PROVIDED THE CHECKPOINT CAN BE SEEN LEFT IN THE PATIENTS BODY. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09/23/2019. 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 W64053-2 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE OF CHECKPOINT LEFT IN PATIENT BODY CAN BE CONFIRMED FROM THE X- RAY PROVIDED IN THE COMMUNICATION LOG, THERE IS NO FAILURE OF THE DEVICE. 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 THAT THERE HAVE BEEN NO NC¿S ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    TIBIA CHECKPOINT WAS LEFT IN PATIENT. CHECKPOINT BECAME DISLODGED DURING TEAMING AND FELL INTO BONY DEFECT IN ACETABULUM AND COULD NOT BE RECOVERED. CASE TYPE: THA. SURGICAL DELAY : 16-30 MINUTES.

    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

    TIBIA CHECKPOINT WAS LEFT IN PATIENT. CHECKPOINT BECAME DISLODGED DURING TEAMING AND FELL INTO BONEY DEFECT IN ACETABULUM AND COULD NOT BE RECOVERED. CASE TYPE: THA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116770 TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 111651 W64053-2 00848486001353

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization