BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST 1.1MM DRILLBIT MINIQUICK

    MDR report key: 6604142 · Received June 1, 2017

    Report

    Report Number
    0001825034-2017-03410
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    March 16, 2017
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT SAMPLE WAS EVALUATED THROUGH A COMPLAINT HISTORY SEARCH AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. WEIGHT ¿ NI, EXPIRATION DATE - N/A, DATE IMPLANTED - N/A, DATE EXPLANTED - N/A, CONCOMITANT DEVICES - FAST 1.1 MM DRILL BIT MINIQUICK CATALOG #: 231220202 LOT #: NI, MANUFACTURE DATE ¿ NI. THIS REPORT WAS PREVIOUSLY SUBMITTED ERRONEOUSLY ON APR 14, 2017 UNDER MANUFACTURING REPORT NUMBER 0001825034-2017-02251-1. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-03409).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A METATARSAL FRACTURE TRAUMA PLATING PROCEDURE, THE DRILL BIT BROKE OFF INTO PATIENT¿S BONE WHILE DRILLING THROUGH THE GUIDE. THE PIECE WAS RETRIEVED AND THE SURGEON CONTINUED SURGERY WITH ANOTHER DRILL BIT. SUBSEQUENTLY, THAT DRILL BIT BROKE AS WELL IN THE PATIENT'S BONE. ALL PIECES WERE RETRIEVED AND THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386178 FAST 1.1MM DRILLBIT MINIQUICK PLATE, FIXATION HTW BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention