BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVIC ARRAY ASSY

    MDR report key: 7272014 · Received February 14, 2018

    Report

    Report Number
    3005985723-2018-00075
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 17, 2018
    Report Date
    June 19, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE PELVIC ARRAY ASSEMBLY BROKE WHILE TIGHTENING. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS THUMB SCREW DAMAGE. SEE ATTACHMENT 1 FOR IMAGE OF THE INSTRUMENT. DIMENSIONAL INSPECTION WAS NOT COMPLETED SINCE VISUAL AND FUNCTIONAL INSPECTION CONFIRMED DAMAGED THUMB SCREW. FUNCTIONAL INSPECTION CONFIRMED PELVIC ARRAY ASSEMBLY, P/N 112230 DAMAGED THUMB SCREW NOT ENGAGING PROPERLY. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED UNDER LOT NO 1945616 AND ACCEPTED INTO FINAL STOCK ON 10/01/2016. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112230, LOT 19450616 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: VISUAL INSPECTION CONFIRMED DAMAGED THUMB SCREW. FUNCTIONAL INSPECTION CONFIRMED THUMB SCREW NOT ENGAGING ONTO ARRAY ADAPTER. 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

    BROKEN PELVIC ARRAY. THA PROCEDURE DELAYED FOR 5 MINUTES.

    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

    BROKEN PELVIC ARRAY. THA PROCEDURE DELAYED FOR 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113672 PELVIC ARRAY ASSY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19450616

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization