BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 7017446 · Received November 10, 2017

    Report

    Report Number
    3005985723-2017-00540
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    November 7, 2017
    Report Date
    January 18, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: HIP END EFFECTOR COLLAR BROKE DURING IMPACTION. THA PROCEDURE. 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 AND 202870 HIP CHUCK SLIDE ASSEMBLY. VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. 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 45 DEVICES WERE MANUFACTURED UNDER LOT NO 19430816 AND (B)(4) INCLUDING S/N (B)(4) ACCEPTED INTO FINAL STOCK ON 04/20/2016. A REVIEW OF (B)(4) REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED P/N 206967, LOT 19490816 SHOWS 1 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. (B)(4). CONCLUSIONS: ALLEGED FAILURE CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: CAPA 1450905 WAS INITIATED BASED ON OTHER COMPLAINTS REPORTING THIS ISSUE.

    Description of Event or Problem · 0

    HIP END EFFECTOR COLLAR BROKE DURING IMPACTION. THA PROCEDURE.

    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

    HIP END EFFECTOR COLLAR BROKE DURING IMPACTION. THA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800083 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization