BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ADAPTOR ASSY

    MDR report key: 6701277 · Received July 11, 2017

    Report

    Report Number
    3005985723-2017-00294
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 16, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: IT WAS REPORTED THAT WHILE ASSEMBLING THE 2* FOR THE FREEDOM CLAMP THERE WAS DIFFICULTY. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION SHOWS GALLING/CROSS THREADING ON INTERNAL THREADS OF P/N 112240, LOT # 19050715. SEE ATTACHMENT 1 FOR AN IMAGE OF THE INSTRUMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED SINCE VISUAL AND FUNCTIONAL INSPECTION CONFIRMED GALLING/CROSS THREADING. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION SHOWS ARRAY ADAPTOR SCREW JAMMED PRIOR TO FULLY SEATING FEMORAL AND TIBIAL ARRAY TO ARRAY ADAPTOR. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 198 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 15TH SEPT 2016. NO NON-CONFORMANCE WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 112240, LOT NUMBER 19050715 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: FUNCTIONAL AND VISUAL INSPECTION CONFIRMED THREAD GALLING/CROSS THREADING. OVER TIGHTENING CAN BE THE CAUSE OF GALLING/CROSS THREAD. 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

    WHEN ASSEMBLING THE 2* FOR THE FREEDOM CLAMP THERE WAS DIFFICULTY, AND IT WAS DETERMINED AFTER THE CASE THAT THE PIECE WAS CROSS THREADED. CASE TYPE: PKA.

    Description of Event or Problem · 1

    WHEN ASSEMBLING THE 2* FOR THE FREEDOM CLAMP THERE WAS DIFFICULTY, AND IT WAS DETERMINED AFTER THE CASE THAT THE PIECE WAS CROSS THREADED. CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481774 PELVIC ARRAY ADAPTOR ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19050715

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization