BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT ASSEMBLY

    MDR report key: 9396896 · Received December 2, 2019

    Report

    Report Number
    3005985723-2019-00882
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 7, 2019
    Report Date
    February 3, 2020
    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

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11. BASED ON THE RESULTS OF INVESTIGATIO N. REPORTED EVENT: THE LEG HOLDER IS FRAYING AND CATCHING ON THINGS AROUND THE EDGES ON THE CALF AREA. PRODUCT EVALUATION AND RESULTS: VISUAL CONFIRMATIO N CONFIRMS THE BOOT ASSEMBLY HAS CARBON FIBER SPLINTERS. SEE ATTACHED IMAGE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 100 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 06- 05-2018 WITH NO REPORTED DISCREPANCI ES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210098, L/N 2018430420 09 SHOWS 3 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATIO N.PR ID :(B)(4). CONCLUSIONS : PER D03391, PREVENTIVE MAINTENANC E IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATIO N WHICH MAY COMPROMIS E FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE FAILURE MODE WAS CONFIRMED AS ALLEGED VIA VISUAL INSPECTION. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREV ENTIVE 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

    THE LEG HOLDER IS FRAYING AND CATCHING ON THINGS AROUND THE EDGES ON THE CALF AREA. CASE TYPE: 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

    THE LEG HOLDER IS FRAYING AND CATCHING ON THINGS AROUND THE EDGES ON THE CALF AREA. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192749 BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 210080 201843042009 00848486031879

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization