BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6496883 · Received April 17, 2017

    Report

    Report Number
    3005985723-2017-00176
    Event Type
    Injury
    Date Received
    April 17, 2017
    Date of Event
    April 10, 2017
    Report Date
    June 16, 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

    REPORTED EVENT: THE REPORTED DEVICE, 3.2 MM X 110 MM 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 3.2 MM X 110 MM BONE PIN, STERILE 2-PACK, P/N 143110, LOT# W42545. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (NON-STERILE P/N 143000-04 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND ACCEPTED ON AUGUST 27TH, 2015. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143110, LOT NUMBER W42545 SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    A SECOND SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE EXECUTIVE SUMMARY FROM PARTIAL KNEE ARTHROPLASTY TO TOTAL KNEE ARTHROPLASTY.

    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

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE PINS BROKE OFF IN THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A TOTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE PINS BROKE OFF IN THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE PINS BROKE OFF IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279220 BONE PIN, 3.2MM X 110MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W425453

    Patients

    Seq Age Sex Outcome Treatment
    1 Other