BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 110MM, STERILE 2 PACK

    MDR report key: 7746996 · Received August 3, 2018

    Report

    Report Number
    3005985723-2018-00454
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    July 24, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486018139
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AFTER THE TKA MAKO CASE WAS DONE IT WAS NOTICED THE EXTRA-INCISION BONE PIN TIPS ON THE 3.2X110 BONE PINS USED HAD BOTH BROKEN OFF INSIDE THE PATIENT BONE. WHICH WERE LEFT INSTEAD OF BEING REMOVED. THIS IS THE 2ND INCIDENT AT OUR LOCATION ANY INFORMATION WOULD BE BENEFICIAL. MPS CORRECTED SURGICAL DELAY FOR 20 MINUTES, PATIENT WAS UNDER ANESTHESIA. DEVICE EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 2536 DEVICES WERE MANUFACTURED UNDER LOT NO W53978 AND ACCEPTED INTO FINAL STOCK ON 09/22/2017. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, L/N W47865 SHOWS 3 ADDITIONAL COMPLAINTS UNDER INVESTIGATION RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE PRS ARE (B)(4). CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN ONE NC AND 2 CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THE NC AND CAPAS ARE NC 1470754 CAPA 1480798 CAPA 301. ONE CAPA HAS BEEN COMPLETED (CATSWEB SYSTEM IS CAPA 301) WHILE THE SECOND IS STILL OPEN (B)(4). DEVICE NOT RETURNED

    Description of Event or Problem · 0

    AFTER THE TKA MAKO CASE WAS DONE IT WAS NOTICED THE EXTRA-INCISION BONE PIN TIPS ON THE 3.2X110 BONE PINS USED HAD BOTH BROKEN OFF INSIDE THE PATIENT BONE. WHICH WERE LEFT INSTEAD OF BEING REMOVED. THIS IS THE 2ND INCIDENT AT OUR LOCATION ANY INFORMATION WOULD BE BENEFICIAL. SURGICAL DELAY: 16-30 MINUTES.

    Additional Manufacturer Narrative · 1

    AS PART OF 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

    AFTER THE TKA MAKO CASE WAS DONE IT WAS NOTICED THE EXTRA-INCISION BONE PIN TIPS ON THE 3.2X110 BONE PINS USED HAD BOTH BROKEN OFF INSIDE THE PATIENT BONE. WHICH WERE LEFT INSTEAD OF BEING REMOVED. THIS IS THE 2ND INCIDENT AT OUR LOCATION ANY INFORMATION WOULD BE BENEFICIAL. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590444 BONE PIN, 3.2MM X 110MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W53978-1 00848486018139

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization