BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL ARRAY POST ASSEMBLY

    MDR report key: 5495108 · Received March 11, 2016

    Report

    Report Number
    3005985723-2016-00082
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IDENTIFICATION: THE REPORTED DEVICE WAS CONFIRMED TO BE A FEMORAL ARRAY POST ASSEMBLY, P/N 160245, LOT 06091011, RMA (B)(4). DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS THE PORTION OF THE PIN OUTSIDE THE HOLE IN THE POST HAS BROKEN OFF. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 6 DEVICES WERE RECEIVED AND ACCEPTED INTO FINAL STOCK ON 10/17/2011. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 160245, LOT NUMBER 06091011 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 160245 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST (B)(4). CONCLUSIONS: THE FAILURE MODE WAS CONFIRMED. THE PIN ON THE SIDE OF THE POST HAD BROKEN. 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 PERFORMED A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER BROACHING, THE SURGEON ATTEMPTED TO ROTATE THE SCREW TO GET A PASSING CHECKPOINT BUT THE SIDE PIN THAT HOLDS THE FEMORAL ARRAY IN THE SCREW BROKE. THE SURGEON SUCTIONED AND WASHED OUT THE WOUND, BUT WAS UNABLE TO FIND THE PIN. THERE IS A POTENTIAL FOR SMALL PIN TO BE INSIDE THE PATIENT AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). AFTER BROACHING THE SURGEON ATTEMPTED TO ROTATE THE SCREW TO GET A PASSING CHECKPOINT BUT THE SIDE PIN THAT HOLDS THE FEMORAL ARRAY IN THE SCREW BROKE. THE SURGEON SUCTIONED AND WASHED OUT THE WOUND, BUT WAS UNABLE TO FIND THE PIN. THERE IS A POTENTIAL FOR SMALL PIN TO BE INSIDE THE PATIENT AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151602 FEMORAL ARRAY POST ASSEMBLY STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. 06091011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other