BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAM 4.3MM SHORT DRILL

    MDR report key: 3912183 · Received May 13, 2014

    Report

    Report Number
    9615741-2014-00024
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING METATARSOPHALANGEAL JOINT (MPJ FOOT SURGERY) TWO PIECES FROM THE TIP OF THE DRILL BROKE OFF INSIDE THE METATARSAL HEAD OF THE PATIENT WHEN THE SURGEON WAS COUNTER SINKING THE SCREW. THE PIECES WERE SEEN ON FLUOROSCOPY AFTER SURGERY. THE PIECES OF THE DRILL WERE NOT REMOVED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED, TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285465 DIAM 4.3MM SHORT DRILL NA HTW NEWDEAL S.A. F64G

    Patients

    Seq Age Sex Outcome Treatment
    1