BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 6146128 · Received December 5, 2016

    Report

    Report Number
    3005985723-2016-00414
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 30, 2016
    Report Date
    April 20, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: SURGEON TIGHTENED ARRAY SCREW AND THE SCREW BROKE DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS MISSING 111462 WING SCREW, 112232 DOWEL PIN, AND 112315 ARRAY CLAMP ADAPTER WASHER. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED DUE TO VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED DUE TO VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS CONFIRMED TO BE A PELVIC ARRAY ASSY , P/N 112230, LOT 19010813. COMPLAINT HISTORY REVIEW: <SUMMARY OF COMPLAINT HISTORY REVIEW> CONCLUSIONS: INSPECTION CONFIRMS MISSING 111462 WING SCREW, 112232 DOWEL PIN, AND 112315 ARRAY CLAMP ADAPTER WASHER. 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.

    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 TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHEN THE SURGEON TIGHTENED THE ARRAY SCREW, THE SCREW BROKE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHEN THE SURGEON TIGHTENED THE ARRAY SCREW, THE SCREW BROKE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHEN THE SURGEON TIGHTENED THE ARRAY SCREW, THE SCEW BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796528 PELVIC ARRAY ASSY STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19010813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization