BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7685494 · Received July 13, 2018

    Report

    Report Number
    3005985723-2018-00418
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    July 10, 2018
    Report Date
    December 5, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486018122
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TIP OF THE 3.2X80MM BONE PIN WAS NOT INTACT WHEN THE SURGEON REMOVED THE PIN FROM THE PATIENT'S TIBIA. NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. NC 1694916 HAS BEEN INITIATED IN REGARDS TO MISSING PRODUCT. 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. 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. 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 RE-OPENED. 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

    THE TIP OF THE 3.2X80MM BONE PIN WAS NOT INTACT WHEN THE SURGEON REMOVED THE PIN FROM THE PATIENT'S TIBIA. CASE TYPE: PKA. WAS THERE A SURGICAL DELAY?. YES - =15 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

    THE TIP OF THE 3.2X80MM BONE PIN WAS NOT INTACT WHEN THE SURGEON REMOVED THE PIN FROM THE PATIENT'S TIBIA. CASE TYPE: PKA. WAS THERE A SURGICAL DELAY? YES - =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528681 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W45250-3 00848486018122

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization