BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T20 DRIVER BIT

    MDR report key: 3033764 · Received April 3, 2013

    Report

    Report Number
    8010764-2013-00020
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF DRIVER BIT BROKE DURING PLATE REMOVAL SURGERY. BACK UP DEVICE WAS USED AND IT BROKE. SURGERY TIME WAS EXTENDED 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136419 T20 DRIVER BIT T-20 HUDSON BIT MDM SMITH & NEPHEW, INC. 11JTSN065

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)