BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6835009 · Received August 31, 2017

    Report

    Report Number
    3005985723-2017-00413
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 10, 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: HIP END EFFECTOR BROKE DURING IMPACTION. DEVICE 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. VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. FRACTURE IS SEEN AT THE DEGREE MARKERS OF THE 20966 REAMER BARREL. SEE ATTACHMENTS FOR IMAGES OF THE INSTRUMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION AS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT NO 19030415 AND (B)(4) INCLUDING S/N (B)(4) ACCEPTED INTO FINAL STOCK ON 12/13/2014 . A REVIEW OF (B)(4). COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT 19030415 SHOWS 6 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. (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

    HIP END EFFECTOR BROKE DURING IMPACTION.

    Description of Event or Problem · 1

    HIP END EFFECTOR BROKE DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615586 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19030415

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization