BEUDAMED
    FDA Adverse Event Other Summary report: N

    LONG DRILL DIAM 4.3 MM FOR CALCANEUS SCREWS

    MDR report key: 2383920 · Received December 15, 2011

    Report

    Report Number
    9615741-2011-00071
    Event Type
    Other
    Date Received
    December 15, 2011
    Date of Event
    November 23, 2011
    Report Date
    December 15, 2011
    Manufacturer
    NEWDEAL SAS
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A PANTA NAIL LOWER EXTREMITY ARTHRODESIS PROCEDURE, A DRILL GUIDE THAT WAS USED BY THE SURGEON WAS CALIBRATED IN SUCH A WAY THAT THE SCREW DEPTH WAS NOT ACCURATE WHEN MEASURED AGAINST THE DEPTH MARKINGS ON THE DRILL GUIDE. SCREWS WERE INSERTED INTO THE PATIENT THAT WERE 25MM TOO LONG. THE PROCEDURE TIME WAS PROLONGED BY ABOUT THIRTY FIVE MINUTES. THERE WAS NO OTHER REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG DRILL DIAM 4.3 MM FOR CALCANEUS SCREWS PANTA NAIL HSB NEWDEAL SAS E330

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other