BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW PARTIALLY THREADED/38MM

    MDR report key: 3030058 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01770
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE SCREW WAS RETURNED IN TWO PIECES. ONE PIECE IS THE HEAD, SHAFT AND A PORTION OF THREADS. THERE ARE RINGS THE ENTIRE SHAFT LENGTH AND THE THREADS ARE DAMAGED. THE THREAD PEAKS ARE FLATTENED. THE OTHER PIECE IS A SECTION OF PEELED THREADS. THERE IS NO THREAD FORM REMAINING IN THIS SECTION. THE THREAD PROFILE AND THREAD MAJOR DIAMETER COULD NOT BE CHECKED DUE TO DAMAGE. ALL MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO MEET SPECIFICATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE WAS RECEIVED AND IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY FOR A FEMEROL OSTEOTOMY ON (B)(6) 2013: WHILE THE SURGEON WAS INSERTING THE 4.5 CANNULATED SCREW, THE THREADS FROM THE SCREW BEGAN TO UNRAVEL AND CAME OFF IN ONE PIECE. THE SURGEON REMOVED THE SCREW, RETRIEVED THE THREADS AND INSERTED ANOTHER SCREW WITHOUT ANY COMPLICATION. THIS OCCURRED AT THE END OF THE SURGERY AND THE REST OF THE SURGERY REPORTEDLY WENT FINE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND SURGERY WAS NOT PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134670 4.5MM CANNULATED SCREW PARTIALLY THREADED/38MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR