BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 9396699 · Received December 2, 2019

    Report

    Report Number
    3005985723-2019-00867
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 5, 2019
    Report Date
    January 30, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022167
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT STUB ON BOTTOM OF THA END EFFECTOR ARRAY CAME OFF AFTER REMOVAL FROM MAKO ARM (AFTER CASE). PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM .THERE IS OXIDATION AND DISCOLORATION ON THE 202870 SLIDE ASSEMBLY, 202862 BALL RETAINER. THE 202857 DOWEL PIN THAT LOCATES THE 202870 SLIDE ASSEMBLY HAS BACKED OUT, CAUSING THE SLIDE ASSEMBLY TO ROTATE FREELY. THE 202866 RELEASE KNOB IS SHEARED OFF. THE 111777 LOCATING PIN IS MISSING. THE 202866 KNOB AND THE BASE HAVE DENT MARKS. THE DEGREE MARKERS BEARS CRACK/ FRACTURE. 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. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS COMPLETED AS PART OF THE ROOT CAUSE INVESTIGATION OF CAPA 1450905. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND (B)(4) ACCEPTED INTO FINAL STOCK ON 11/28/2016. REVIEW OF QT 16-11-0080 REVEALED THAT (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/23/2019. THE NON CONFORMANCE IS NOT RELATED THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT NUMBER 19530615 SHOWS 5 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE (B)(4). CONCLUSIONS: THE FAILURE IS CONFIRMED VIA VISUAL INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC (B)(4) & CAPA 1450905.

    Description of Event or Problem · 0

    STUB ON BOTTOM OF THA END EFFECTOR ARRAY CAME OFF AFTER REMOVAL FROM MAKO ARM (AFTER CASE). CASE TYPE: THA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    STUB ON BOTTOM OF THA END EFFECTOR ARRAY CAME OFF AFTER REMOVAL FROM MAKO ARM (AFTER CASE). CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192513 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 206967 19530615/1901415 00848486022167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization