BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 5893522 · Received August 22, 2016

    Report

    Report Number
    3005985723-2016-00259
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 16, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE SURGEON DID NOT REMOVE THE TIBIAL CHECKPOINT FROM THE PATIENT¿S ACETABULUM PRIOR TO CLOSING THE INCISION. THE INCISION WAS REOPENED AND THE CHECKPOINT WAS REMOVED. THERE WAS A 30 MINUTE DELAY TO REOPEN THE INCISION AND RETRIEVE THE CHECKPOINT. DEVICE EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY REVIEW: THE LOT NUMBER OF THE DEVICE IN THIS COMPLAINT WAS NOT PROVIDED AND THE PART WAS NOT RETURNED FOR EVALUATION. AS A RESULT, NOT DHR REVIEW CAN BE COMPLETED. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 111651, ALL LOT NUMBERS SHOWS ZERO ADDITIONAL COMPLAINTS IN THE PAST 2 YEARS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 111654 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #925. 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. THE PRODUCT WAS NOT RETURNED FOR EVALUATION.

    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

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER THE SURGERY, IT WAS NOTICED THAT THE CHECKPOINT WAS NOT REMOVED FROM PATIENT. STRYKER REPRESENTATIVE REALIZED, NOTIFIED SURGEON AND MEDICAL INTERVENTION WAS PERFORMED TO REMOVE CHECKPOINT. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER THE SURGERY, IT WAS NOTICED THAT THE CHECKPOINT WAS NOT REMOVED FROM PATIENT. STRYKER REPRESENTATIVE REALIZED, NOTIFIED SURGEON AND MEDICAL INTERVENTION WAS PERFORMED TO REMOVE CHECKPOINT. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546038 TIBIAL, CHECKPOINT, STERILE STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention