BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 4100720 · Received September 12, 2014

    Report

    Report Number
    2134070-2014-00165
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 18, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS A CLASS I DEVICE. THE DEVICE WAS NOT RETURNED AS OF THE DATE OF THIS REPORT AND WAS REPORTED TO BE HELD BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE THE DEVICE BROKE WHILE IN USE IN THE BONE. THE BROKEN TIP COULD NOT BE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565066 NA ORTHORPEDIC DRILL BIT HTW STERILMED, INC. SYN310.25

    Patients

    Seq Age Sex Outcome Treatment
    1 Other