BEUDAMED
    FDA Adverse Event Summary report: N

    LOCKSCR 5 L42 F/NAILS TAN LIGHT GREEN

    MDR report key: 2832620 · Received November 14, 2012

    Report

    Report Number
    8030965-2012-01043
    Date Received
    November 14, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A SURGEON IS (B)(6) REPORTED: DURING A PROCEDURE ON (B)(6) 2012, SURGEON WAS INSERTING THE DISTAL LOCKING SCREW, AS HE INSERTED HE HAD TO EXERT UNDUE PRESSURE WHEN ADVANCING INTO THE MEDIAL SIDE OF THE NAIL. SURGEON WAS DISSATISFIED WITH THE PRESSURE REQUIRED AND DECIDED TO REMOVE THE SCREW AND USE ANOTHER SCREW. THE SECOND SCREW ADVANCED WITH NO PRESSURE. THE OCCURRENCE ADDED 15 MINUTES TO THE PROCEDURE. SURGEON HAD CONCERNS ABOUT THE PROLONGATION AS PT HAS DEEP VEIN THROMBOSIS. OUT COME OF THIS SURGERY WAS SATISFACTORY. HOSPITAL DISCARDED THE SCREW USED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKSCR 5 L42 F/NAILS TAN LIGHT GREEN LOCKSCREW KTT SYNTHES GMBH 7817728

    Patients

    Seq Age Sex Outcome Treatment
    1 NAIL| LOCKSCREW