BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 9452834 · Received December 11, 2019

    Report

    Report Number
    3005985723-2019-00900
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 13, 2019
    Report Date
    February 3, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486022167
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT REAR LOCKING MECHANISM BROKEN OFF AT THE THREADS. 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 206966 REAMER BARRELL HAS FRACTURES/CRACKS AT THE DEGREE MARKERS . THE 202866 RELEASE KNOB IS SHEARED OFF. 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 WAS 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 PRODUCT HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND (B)(4)WERE ACCEPTED INTO FINAL STOCK ON 11/03/2017. REVIEW OF QT 17- 11 -0006 REVEALED THAT THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT NUMBER 19420816 SHOWS 14 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 1414603 & CAPA 1450905.

    Description of Event or Problem · 0

    REAR LOCKING MECHANISM BROKEN OFF AT THE THREADS. 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

    REAR LOCKING MECHANISM BROKEN OFF AT THE THREADS. CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243986 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 206967 1901706 00848486022167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other