BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY CLAMP ASSEMBLY

    MDR report key: 5480126 · Received March 4, 2016

    Report

    Report Number
    3005985723-2016-00077
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICES ARE ARRAY CLAMP ASSEMBLY, CATALOG # 112100, LOT #19020214 QTY: 4. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION, VISUAL INSPECTION SHOWS NO VISIBLE DAMAGE TO THE PARTS. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS DONE BECAUSE THE INCOMING INSPECTION REPORTED NO NONCONFORMANCES AND THE VISUAL INSPECTION CLEARLY SHOWS THE PARTS TO BE DAMAGE FREE. FUNCTIONAL INSPECTION: A 112310 TIBIAL ARRAY WAS ASSEMBLED INTO THE CLAMPS AND TIGHTENED WITH NO ISSUE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT (B)(4) PARTS WERE MANUFACTURED, INSPECTED AND ACCEPTED INTO FINAL STOCK ON 9/9/14 WITH NO REPORTED NONCONFORMANCES. COMPLAINT HISTORY REVIEW: A REVIEW OF THE TRACKWISE AND CATSWEB DATABASES FOR COMPLAINTS RELATED TO P/N 112100, SHOWS 2 COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION OF TIGHTENING INADEQUACY. THE CATSWEB COMPLAINTS ARE ISSUE (B)(4). TRACKING OF COMPLAINTS RELATED TO THIS PART WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #813. CONCLUSIONS: THE FAILURE MODE REPORTED WAS NOT CONFIRMED, THE CLAMPS FUNCTION AS DESIGNED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST AN UNANTICIPATED HAZARD.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE THE MAKO UNI KNEE CLAMPS DIDN'T TIGHTEN AS MUCH AS WE WOULD HAVE LIKED CAUSING A DELAY OF APPROXIMATELY 30 MINUTES. THE CASE WAS THEN COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE THE MAKO UNI KNEE CLAMPS DIDN'T TIGHTEN AS MUCH AS WE WOULD HAVE LIKED CAUSING A DELAY OF APPROXIMATELY 30 MINUTES. THE CASE WAS THEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137749 ARRAY CLAMP ASSEMBLY STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. 19020214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other