BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6673059 · Received June 28, 2017

    Report

    Report Number
    3005985723-2017-00279
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    June 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 80MM BONE PIN, WAS NOTICED TO HAVE FRACTURED WHEN INSERTING THE BONE PIN. THE CASE COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY. THE BONE PIN IS BEING HELD BY THE HOSPITAL. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN STRYKER'S DATABASE RELATED TO P/N 143080, LOT NUMBER W45250 SHOWS NO ADDITIONAL COMPLAINT INVESTIGATIONS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: 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 301. 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

    DR WENT TO PLACE THE PIN IN THE TIBIA. AS HE WAS DRILLING THE PIN BROKE. CASE TYPE: PKA; DELAY: 10 MINUTES.

    Description of Event or Problem · 1

    DR WENT TO PLACE THE PIN IN THE TIBIA. AS HE WAS DRILLING THE PIN BROKE. CASE TYPE: PKA; DELAY: 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454464 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W45250

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other