BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIN SCREW DIAM. 2MM LG 14MM

    MDR report key: 1295776 · Received December 1, 2008

    Report

    Report Number
    9615741-2008-00032
    Event Type
    Other
    Date Received
    December 1, 2008
    Date of Event
    November 7, 2008
    Report Date
    December 1, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 WEIL OSTEOTOMY PROCEDURE, THE SURGEON MADE A PILOT HOLE WITH A .45IN K WIRE, AND THEN STARTED TO INSERT THE SPIN SCREW. THE SPIN SCREW SNAP OFF PART BROKE OFF WITHIN A FEW TURNS OF THE SCREW. THE SURGEON THEN STARTED TO TURN THE SCREW USING THE HEAD OF THE SCREW AND WITHIN A QUARTER OF A TURN, THE SCREW HEAD BROKE OFF FROM THE SHAFT OF THE SCREW. WHEN THE SURGEON TRIED TO REMOVE THE REMAINING PART OF THE SCREW, USING FORCEPS, THE SCREW THEN BROKE AGAIN IN THE MIDDLE OF THE SHAFT. THE LEAD PART OF THE SCREW REMAINS IN THE PATIENT BECAUSE THE DOCTOR WAS UNABLE TO REMOVE IT. THERE HAVE BEEN NO POST OPERATIVE COMPLICATIONS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIN SCREW DIAM. 2MM LG 14MM TITANIUM SNAP-OFF SCREW HWC NEWDEAL S.A. E59A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention