BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE

    MDR report key: 2873476 · Received December 14, 2012

    Report

    Report Number
    1719045-2012-01364
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K092646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, THE LAG SCREW WOULD NOT ADVANCE INTO THE 135 DEGREE NAIL USING THE 130 DEGREE JIG. SURGEON REMOVED THE LAG SCREW AND NAIL AND REPLACED WITH 130 DEGREE NAIL USING THE 130 DEGREE JIG. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM AND NO REPORTED HARM TO PATIENT. THIS REPORT IS #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE 11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE HSB SYNTHES MONUMENT 6994999

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NAIL, AIMING ARM