BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS 2IN1 DRILL

    MDR report key: 2062429 · Received March 18, 2011

    Report

    Report Number
    2032499-2011-00091
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 9, 2011
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAPPENS WHEN A SURGEON POWERS THE DRILL OVER THE WIRE, WHILE HOLDING THE POWERED DRILL AT AN ANGLE SKEWED AWAY FROM THE TRAJECTORY OF THE K-WIRE. IN ADDITION, THE IFU STATES THAT THIS IS TO BE USED FOR ONE CASE ONLY, AND THEN DISCARDED. AN EVALUATION OF THE DRILL WILL BE PERFORMED WHEN IT IS RETURNED.

    Description of Event or Problem · 1

    A 2IN1 DRILL SPLIT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS 2IN1 DRILL HTW INTERVENTIONAL SPINE, INC. 6070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention