BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 7017623 · Received November 10, 2017

    Report

    Report Number
    3005985723-2017-00550
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    November 9, 2017
    Report Date
    March 6, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE SLEEVE BECAME UNATTACHED FROM THE BACK OF THE END EFFECTOR. THA PROCEDURE. PRODUCT EVALUATION AND RESULTS: "VISUAL INSPECTION VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM . DISCOLORATION AND WEAR ARE SEEN ON THE 202862 HIP BALL RETAINER AND 202870 HIP CHUCK 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." PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT NO 19410515 AND 38 INCLUDING (B)(4) ACCEPTED INTO FINAL STOCK ON 08/30/2016. REVIEW OF (B)(4) REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THE COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT NUMBER 19410515 SHOWS 08 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE PR 1366515,1435691, 1459177, 1486114, 1499506, 1508681, 1685698, 1639667 CONCLUSIONS: FAILURE MODE CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NCS AND CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC 1414603 AND CAPA 1450905

    Description of Event or Problem · 0

    THE SLEEVE BECAME UNATTACHED FROM THE BACK OF THE END EFFECTOR. 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

    THE SLEEVE BECAME UNATTACHED FROM THE BACK OF THE END EFFECTOR. THA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798288 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization