BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERI-LOC

    MDR report key: 1972367 · Received January 18, 2011

    Report

    Report Number
    1972367
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    TWO DRILL BITS BROKE IN THE PATIENT'S LEG DURING USE. THE DRILL BITS WERE USED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-LOC PLATE, FIXATION, BONE, DRILL BIT HRS SMITH AND NEPHEW, INC. 7117-3503 *
    2 PERI-LOC PLATE, FIXATION, BONE, DRILL BIT HRS SMITH AND NEPHEW, INC. 7117-3504 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR