BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCODER, J6, HIP 190-00137

    MDR report key: 8633415 · Received May 22, 2019

    Report

    Report Number
    3005985723-2019-00380
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 29, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: MPS (B)(6) REPORTED J6 ENCODER ERROR AND HIGHLY INACCURATE CUTS. AS PER THE MPS: "THE TIBIAL SURFACE AND PEG HOLES WERE THE INACCURATE CUTS AND THEY WERE ABOUT 5MM'S OFF TARGET. SORRY, NO XRAYS, THE ARE PASSWORD PROTECTED AND I DO NOT HAVE ACCESS". DEVICE EVALUATION AND RESULTS: PER (B)(4): INSPECTED THE J6 GLASS ENCODER SCALE. CLEANED AN ABNORMAL AMOUNT OF DUST FROM THE J6 GLASS ENCODER. PERFORMED VERIFICATION TESTING TO CONFIRM THE ISSUE WAS RESOLVED. SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 12/06/2010, 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 10-10-0113, NPR 10-11-0037, NPR 10-11-0053, NPR 10-11-0100, NPR 10-12-0008, NPR 10-11-0060, NPR 10-11-0012, NPR 10-11-0039, NPR 10-10-0001, NPR 10-10-0037, NPR 10-10-0139, NPR 10-11-0040, NPR 10-11-0075, NPR 10-10-0050. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 203486 SHOWS 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. 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 · 0

    CASE NUMBER: (B)(4), MPS (B)(6) REPORTED J6 ENCODER ERROR AND HIGHLY INACCURATE CUTS. CASE TYPE: PKA. UPDATE: LESS THAN 30MIN DELAY. AS PER THE MPS: "THE TIBIAL SURFACE AND PEG HOLES WERE THE INACCURATE CUTS AND THEY WERE ABOUT 5MM'S OFF TARGET. SORRY, NO XRAYS, THE ARE PASSWORD PROTECTED AND I DO NOT HAVE ACCESS".

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    CASE NUMBER: (B)(4), MPS WILLIAM CRAIG REPORTED J6 ENCODER ERROR AND HIGHLY INACCURATE CUTS. CASE TYPE: PKA. UPDATE: LESS THAN 30MIN DELAY. AS PER THE MPS: "THE TIBIAL SURFACE AND PEG HOLES WERE THE INACCURATE CUTS AND THEY WERE ABOUT 5MM'S OFF TARGET. SORRY, NO XRAYS, THE ARE PASSWORD PROTECTED AND I DO NOT HAVE ACCESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424741 ENCODER, J6, HIP 190-00137 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization