BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS

    MDR report key: 3702281 · Received March 26, 2014

    Report

    Report Number
    2520274-2014-00972
    Event Type
    Injury
    Date Received
    March 26, 2014
    Report Date
    March 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IDENTIFIED (B)(4) 2014. PRODUCT DEVELOPMENT EVALUATED THE RETURNED DEVICES. THE RAFNAIL AND LOCKING SCREWS ARE PART OF THE TI CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL EXPERT NAILING SYSTEM (RAFN) AND INDICATED FOR THE STABILIZATION OF FRACTURES IN THE DISTAL FEMUR AND FEMORAL SHAFT (TECHNIQUE GUIDE J-5513-D). THE RETURNED COMPONENTS WERE RECEIVED INTACT HOWEVER THE SCREWS AND DYNAMIC SCREW HOLES OF THE NAIL SHOW UNUSUAL WEAR CONTACT PATTERNS THAT WOULD NOT RESULT IN OPTIMAL DYNAMIZATION OF THE FEMORAL NAIL. THE USE OF THE DYNAMIC SLOTS BOTH DISTAL AND PROXIMAL ARE EVIDENCE THAT DYNAMIZATION WAS ATTEMPTED HOWEVER, THE DISTAL PROXIMAL DYNAMIC HOLE HAS EVIDENCE THAT THE SCREW WAS JAMMED AND LOCKED WITHIN BOTH EDGES OF THE DYNAMIC SLOT WITH NO EVIDENCE OF DYNAMIC MOVEMENT WEAR. PROXIMALLY, A LOCKING SCREW HOLE AND THE DYNAMIC SCREW HOLES WERE UTILIZED. THE USE OF THE LOCKING SCREW HOLE WOULD DEFEAT ANY DYNAMIC FUNCTION OF THE DYNAMIC SCREW SLOT PROXIMALLY AS WELL AND CONSEQUENTLY THE ENTIRE CONSTRUCT WOULD NOT BE ABLE TO MOVE DYNAMICALLY. IT IS POSSIBLE THAT THE LACK OF INTENDED OPTIMIZATION FOR DYNAMIC FUNCTION OF THE CONSTRUCT COULD HAVE LED TO THE PATIENT REACTION (DISCOMFORT) DESCRIBED IN THIS COMPLAINT DESCRIPTION. (B)(4) WERE REVIEWED AND ARE DETERMINED TO BE SUITABLE FOR THE DESIGN, APPLICATIONS AND DIMENSIONAL CONFORMITY FOR THE RAFN AND RELATED SCREWS. IT IS APPARENT THAT THE METHOD OF USE RATHER THAN A DESIGN DEFICIENCY HAS LED TO THIS COMPLAINT. THE DESIGN OF THE RAFNAIL AND RELATED SCREWS ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD A RETROGRADE FEMORAL NAIL IMPLANTED IN (B)(6) 2009. THE SURGEON DECIDED TO REVERT TO A TOTAL KNEE AND REMOVE THE NAIL DUE TO DISCOMFORT. IT WAS ALSO REPORTED THAT THE PATIENT WAS INFORMED DURING THE ORIGINAL IMPLANT THAT THEY WOULD EVENTUALLY BE REVISED TO A TOTAL KNEE. THE NAIL WAS FULLY INTACT. THE FRACTURE WAS HEALED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS IS REPORT 4 OF 5 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176975 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention