BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT ASSEMBLY

    MDR report key: 9362266 · Received November 22, 2019

    Report

    Report Number
    3005985723-2019-00838
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 30, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: CPD STAFF ALERTED ME THAT THE BLACK LEG HOLDER HAS BEGUN TO SPLINTER NEAR THE UPPER LEFT PORTION OF THE BOOT THAT WILL CAUSE POTENTIAL HARM TO PATIENTS AS WELL AS STAFF. THEY REQUEST A REPLACEMENT. CASE TYPE: TKA. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMS THE LEG HOLDER HAS SPLINTERED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 06-05-2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210098, L/N 201843042009 SHOWS ONE ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION, (B)(4). CONCLUSIONS: THE EVENT WAS CONFIRMED. 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. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. 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

    CPD STAFF ALERTED ME THAT THE BLACK LEG HOLDER HAS BEGUN TO SPLINTER NEAR THE UPPER LEFT PORTION OF THE BOOT THAT WILL CAUSE POTENTIAL HARM TO PATIENTS AS WELL AS STAFF. THEY REQUEST A REPLACEMENT. CASE TYPE: TKA.

    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

    CPD STAFF ALERTED ME THAT THE BLACK LEG HOLDER HAS BEGUN TO SPLINTER NEAR THE UPPER LEFT PORTION OF THE BOOT THAT WILL CAUSE POTENTIAL HARM TO PATIENTS AS WELL AS STAFF. THEY REQUEST A REPLACEMENT. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155222 BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 201843042009 00848486031879

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization