BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT ASSEMBLY

    MDR report key: 9577472 · Received January 10, 2020

    Report

    Report Number
    3005985723-2020-00019
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 13, 2019
    Report Date
    March 18, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031879
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION CAPA 2127499 HAS BEEN RAISED FOR THE SAME. PRODUCT HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORDS OF LOT NUMBER 201843042009 REVEALED THAT 100 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 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION.PR ID :(B)(4). CONCLUSION: 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 HAS BEEN NO NC OR CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT. ¿ A STAFF MEMBER.

    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

    STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37600 BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 210080 2018433042009 00848486031879

    Patients

    Seq Age Sex Outcome Treatment
    1 Other