BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 80MM, STERILE 2 PACK

    MDR report key: 7552797 · Received May 30, 2018

    Report

    Report Number
    3005985723-2018-00314
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 3, 2018
    Report Date
    July 20, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT WHEN DRILLING 3.2MM X 80MM BONE PIN INTO TIBIA END OF PIN SNAPPED OFF IN PATIENT'S TIBIA. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 306 DEVICES WERE MANUFACTURED UNDER LOT NO W45250-3 AND ACCEPTED INTO FINAL STOCK ON 09/01/2016. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, LOT NUMBER W45250-3 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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 HAVE BEEN 01 NCS 1470754 AND CAPAS 1480798 ARE ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    WHEN DRILLING 3.2MM X 80MM BONE PIN INTO TIBIA END OF PIN SNAPPED OFF IN PATIENT'S TIBIA. PKA CASE DELAYED LESS THAN 15 MINUTES. ADDITIONAL INFORMATION: ISSUE OCCURRED INTRA-OP AS CONFIRMED BY MPS.

    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 DRILLING 3.2MM X 80MM BONE PIN INTO TIBIA END OF PIN SNAPPED OFF IN PATIENT'S TIBIA. PKA CASE DELAYED LESS THAN 15 MINUTES. ADDITIONAL INFORMATION: ISSUE OCCURRED INTRA-OP AS CONFIRMED BY MPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396927 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W45250-3

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization