BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 MM CORTEX SCREW SLF-TPNG

    MDR report key: 2033491 · Received March 23, 2011

    Report

    Report Number
    8030965-2011-00086
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE REMAINS IN THE PT. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION CAN BE DRAWN. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A PROCEDURE AT (B)(6), SURGEON WAS PLACING AN LCP COMPACT 2.0 STRAIGHT 5-HOLE PLATE ON THE THIRD METACARPAL AND TWO 2.0MM CORTEX SCREWS BROKE DURING INSERTION. DEVICE REPORT INDICATES THE BROKEN SCREWS WERE NOT RETRIEVED, AND PROCEDURE WAS COMPLETED. THIS REPORT IS #1 OF 2 FOR THE SAME INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0 MM CORTEX SCREW SLF-TPNG 2.0 MM CORTEX SCREW SLF-TPNG HWC SYNTHES GMBH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR PLATE