BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6820622 · Received August 25, 2017

    Report

    Report Number
    3005985723-2017-00392
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    August 15, 2017
    Report Date
    October 23, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HIP END EFFECTOR WOULD NOT ACCEPT A REAMER SHAFT OR IMPACTOR SHAFT. THE CASE WAS SWITCHED TO A MANUAL HIP. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM WITH BALL BEARINGS FAILING. DISCOLORATION AND WEAR ARE SEEN ON THE 202862 HIP BALL RETAINER AND 202870 HIP CHUCK SLIDE ASSEMBLY . THE 202857 DOWEL PINS ARE SEEN TO BE PROUD AND FLUSH ALONG THE BODY OF THE END EFFECTOR. FRACTURES ARE SEEN AT THE DEGREE MARKERS OF THE 20966 REAMER BARREL. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL AND FUNCTIONAL TESTING CONFIRM ALLEGED FAILURE MODE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION SHOWS THAT THE 202866 HIP RELEASE KNOB IS ABLE TO UNTHREAD FROM THE ASSEMBLY. FUNCTIONAL TESTING ALSO SHOWS THAT THE 202870 HIP CHUCK SLIDE ASSEMBLY IS STUCK IN PLACE AND DOES NOT MOVE THIS WOULD CAUSE THE OBSERVED FAILURE OF THE HIP END EFFECTOR ASSEMBLY NOT ACCEPTING MATING COMPONENTS. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09/11/2015. NO NON-CONFORMANCE'S WERE IDENTIFIED DURING INSPECTION OF S/N (B)(4). COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT NUMBER 19021214 SHOWS 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: ALLEGED FAILURE CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA (B)(4) WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    Description of Event or Problem · 1

    THE HIP END EFFECTOR WOULD NOT ACCEPT A REAMER SHAFT OR IMPACTOR SHAFT. THE CASE WAS SWITCHED TO A MANUAL HIP.

    Description of Event or Problem · 1

    THE HIP END EFFECTOR WOULD NOT ACCEPT A REAMER SHAFT OR IMPACTOR SHAFT. THE CASE WAS SWITCHED TO A MANUAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602048 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization