BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 140MM, STERILE 2 PACK

    MDR report key: 6727949 · Received July 20, 2017

    Report

    Report Number
    3005985723-2017-00323
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    July 17, 2017
    Report Date
    October 23, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. WHEN THE SURGEON REMOVED THE 3.2 X 140MM FEMORAL BONE PINS (PART# 143140 LOT# W50288) AFTER THE MAKO TKA WAS COMPLETE, HE NOTICED THE END OF ONE OF THE PINS BROKE OFF AND WAS NOT INTACT WITH THE REST OF THE PIN. THE SURGEON REPORTED THAT THERE WAS NO PATIENT HARM AND THAT THE PROCEDURE WAS COMPLETED WITH OPTIMAL RESULTS. STABILIZERS WERE USED AND X-RAYS ARE UNAVAILABLE. PRODUCT INSPECTION WAS NOT PERFORMED SINCE THE DEVICE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED 1805 WERE MANUFACTURED AND ACCEPTED ON JANUARY 18, 2017. A REVIEW OF COMPLAINTS IN (B)(6) AND TRACKWISE RELATED TO P/N 143140, LOT NUMBER W50288 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN TWO CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. ONE CAPA HAS BEEN COMPLETED (B)(6) SYSTEM IS CAPA (B)(4)) WHILE THE SECOND IS STILL OPEN (TRACKWISE (B)(4)). THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    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

    WHEN THE SURGEON REMOVED THE 3.2 X 140MM FEMORAL BONE PINS (PART# 143140 LOT# W50288) AFTER THE MAKO TKA WAS COMPLETE, HE NOTICED THE END OF ONE OF THE PINS BROKE OFF AND WAS NOT INTACT WITH THE REST OF THE PIN. THE SURGEON REPORTED THAT THERE WAS NO PATIENT HARM AND THAT THE PROCEDURE WAS COMPLETED WITH OPTIMAL RESULTS.

    Description of Event or Problem · 1

    WHEN THE SURGEON REMOVED THE 3.2 X 140MM FEMORAL BONE PINS (PART# 143140 LOT# W50288) AFTER THE MAKO TKA WAS COMPLETE, HE NOTICED THE END OF ONE OF THE PINS BROKE OFF AND WAS NOT INTACT WITH THE REST OF THE PIN. THE SURGEON REPORTED THAT THERE WAS NO PATIENT HARM AND THAT THE PROCEDURE WAS COMPLETED WITH OPTIMAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509826 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W50288

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other