BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, T10, 3.5X14MM

    MDR report key: 3241487 · Received July 22, 2013

    Report

    Report Number
    0008010177-2013-00164
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 26, 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 SCREW HAS BEEN LOCKED TO THE PLATE AS INTENDED, BUT IT WAS TURNED FURTHER AND THEREFORE THE TORX WAS ROUNDED OUT. BECAUSE OF THE DEFORMATIONS, NO FUNCTIONAL INSPECTION COULD BE PERFORMED. ALL DIMENSIONAL INSPECTION VALUES ARE INSIDE THE SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE INVESTIGATED FAILURE MODE OF NO LOCKING POSSIBLE CAN BE ATTRIBUTED TO A USER RELATED ISSUE OF USING HIGH AXIAL FORCES. NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    DURING VARIAX FIBULA SURGERY, THE LOCKING SCREW COULD NOT BE LOCKED. THE SURGEON TRIED TO INSERT IT AT DIFFERENT ANGLES, BUT THE SITUATION DID NOT CHANGE. FINALLY, HE EXTRACTED THE SCREW AND USED OTHER NEW SAME SIZE SCREW. THE NEW SCREW LOCKED WITHOUT ANY PROBLEM.

    Description of Event or Problem · 1

    DURING VARIAX FIBULA SURGERY, THE LOCKING SCREW COULD NOT BE LOCKED. THE SURGEON TRIED TO INSERT IT AT DIFFERENT ANGLES, BUT THE SITUATION DID NOT CHANGE. FINALLY, HE EXTRACTED THE SCREW AND USED OTHER NEW SAME SIZE SCREW. THE NEW SCREW LOCKED WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341392 LOCKING SCREW, T10, 3.5X14MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1