BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, T10, 3.5X16MM

    MDR report key: 3250365 · Received July 26, 2013

    Report

    Report Number
    0008010177-2013-00172
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K063875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. THE INVESTIGATED FAILURE MODE OF ROUNDED OUT SCREW HEAD - TORX CAN BE ATTRIBUTED TO A USER RELATED ISSUE OF USING TOO HIGH TORSIONAL FORCES - EXCESSIVE TIGHTENING DURING INSERTION. BECAUSE OF THE DEFORMATIONS/SHEARED OFF AREA, NO FUNCTIONAL INSPECTION COULD BE PERFORMED. BESIDE THE DEFORMED TORX AND LOCKING THREAD, ALL OTHER DIMENSIONAL INSPECTION VALUES WERE INSIDE THE SPECIFICATION. BASED ON THE EVALUATIONS, THERE WERE NO INDICATIONS FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    DURING VARIAX FIBULA EXTRACTION SURGERY, THE TORX HEAD OF THE LOCKING SCREW WAS BROKEN. THE SCREW COULD BE EXTRACTED AND THE SURGERY WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349998 LOCKING SCREW, T10, 3.5X16MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR