BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 7048267 · Received November 21, 2017

    Report

    Report Number
    7048267
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 3, 2017
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CASE, A 4.5 MM DRILL BIT BROKE OFF IN THE SURGICAL WOUND. IT WAS A DEPUY 4.5MM DRILL BIT, REF #(B)(4). BOTH PIECES OF DRILL BIT WERE IMMEDIATELY RETRIEVED & INTRA-OP X-RAY WAS TAKEN. THE RADIOLOGY ATTENDING READ THE FILM AND CONFIRMED THAT THERE IS NO FOREIGN BODY (DRILL BIT) RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830791 UNKNOWN INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE DEPUY MITEK, INC. PG250319

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR