BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT ASSEMBLY

    MDR report key: 8947002 · Received August 29, 2019

    Report

    Report Number
    3005985723-2019-00622
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 16, 2019
    Report Date
    November 4, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: SPD DISCOVERED THAT THE CARBON FIBER ON THE EDGE OF LEG HOLDER BOOT IS BREAKING AND HAS BECOME VERY SHARP. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS RETURNED FOR INSPECTION. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 8 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 12-21-2015 WITH NO REPORTED DISCREPANCIES. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 6 DEVICES WERE MANUFACTURED AND ALL WERE REJECTED ON 05-07-2015. ALL THESE 6 DEVICES WERE ACCEPTED VIA QT 15-05-0023 ON 05-05-2015. REVIEW OF QT 15-05-0023 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 210080, LOT 201543030604 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PER (B)(4), PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR 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 NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    SPD DISCOVERED THAT THE CARBON FIBER ON THE EDGE OF LEG HOLDER BOOT IS BREAKING AND HAS BECOME VERY SHARP. NO ASSOCIATED PROCEDURE.

    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

    SPD DISCOVERED THAT THE CARBON FIBER ON THE EDGE OF LEG HOLDER BOOT IS BREAKING AND HAS BECOME VERY SHARP. NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739579 BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 201543030604 00848486031879

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization