BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH LONG-HD ATTACHMENT

    MDR report key: 6088268 · Received November 8, 2016

    Report

    Report Number
    3005985723-2016-00369
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DEVICE WAS CONFIRMED TO BE A ANSPACH HD LONG ATTACHMENT, CATALOG # 110920, LOT# J25310715420, RMA #: 235087. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE INSPECTED AND ACCEPTED INTO FINAL STOCK ON 7/11/2015. DEVICE EVALUATION AND RESULTS: NO FAILURE OF THE ATTACHMENT WAS REPORTED. HOWEVER, A FUNCTIONAL EVALUATION WAS PERFORMED. THERE IS A COMPONENT THAT IS BLOCKING PATH OF THE BURR, PREVENTING INSERTION OF THE BURR. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 110920, LOT NUMBER J25310715420 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: NO FAILURE OF THIS DEVICE WAS REPORTED (IT WAS RETURNED WITH ANOTHER REPORTED DEVICE). HOWEVER, DURING AN EVALUATION OF THE DEVICE, A BLOCKAGE OF THE BURR PATH WAS FOUND. 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.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN THE BLACK MAGNET FELL OFF, CAUSING THE HANDPIECE TO STOP WORKING.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN THE BLACK MAGNET FELL OFF, CAUSING THE HANDPIECE TO STOP WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737324 ANSPACH LONG-HD ATTACHMENT STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. J25310715420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization