BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6555096 · Received May 9, 2017

    Report

    Report Number
    3005985723-2017-00206
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    May 8, 2017
    Report Date
    June 6, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE, 3.2MM X 110MM BONE PIN, WAS NOTICED TO BE BROKEN WHEN REMOVING THE BONE PIN IN THE TIBIA. THE PIN FRAGMENTS WERE LEFT IN THE BONE AFTER A SUCCESSFUL TKA CASE. THERE WAS NO SURGICAL DELAY DUE TO THIS FAILURE. THE PINS WERE DISCARDED AND NOT RETURNED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED DEVICE IS A 3.2MM X 110MM BONE PIN, STERILE 2-PACK, P/N 143110, LOT# W44862. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED 1330 DEVICES (NON-STERILE P/N 143000-04 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND ACCEPTED ON DECEMBER 29TH, 2015. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143110, LOT NUMBER W44862 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO P/N 143110 WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #789. CONCLUSION: THE FAILURE WAS CONFIRMED WITHOUT THE EVALUATION OF THE RETURNED DEVICE. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN ONE CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THE CAPA COMPLETED IN THE CATSWEB SYSTEM IS CAPA (B)(4). CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 1

    WHEN DR. (B)(6) WAS REMOVING THE 3.2 X 140 BONE PIN FROM THE PATIENTS TIBIA, THE TIP OF THE PIN BROKE OFF IN THE PATIENTS BONE.

    Description of Event or Problem · 1

    WHEN DR. MULDER WAS REMOVING THE 3.2 X 140 BONE PIN FROM THE PATIENTS TIBIA, THE TIP OF THE PIN BROKE OFF IN THE PATIENTS BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335238 BONE PIN, 3.2MM X 110MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W44862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other