BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR

    MDR report key: 2802823 · Received October 24, 2012

    Report

    Report Number
    8030965-2012-01112
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K092646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. THE TWO TANGS AT THE TIP OF THE RETURNED DEVICE ARE BOTH BENT OUTWARD. ONE IS BENT OUTWARD APPROXIMATELY 20 DEGREES AND THE OTHER BENT OUTWARD APPROXIMATELY 30 DEGREES. BOTH ARE ALSO SLIGHTLY TWISTED IN ADDITION TO BEING BENT AND HAVE NUMEROUS DENTS ON THEM. THE FLATS IN THE HEX RECESS HAVE RAISED METAL AND DENTS. SOME SPOTS OF DISCOLORATION AND WATER MARKS EXIST ON THE HANDLE AND SHAFT. THE DEVICE DESIGN WAS REVIEWED AND IS ADEQUATE FOR THE INTENDED USE AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. IT APPEARS THAT THE INSERTER MAY HAVE BEEN INCORRECTLY ATTACHED TO THE TFN SCREW WHICH COULD CAUSE THE DEFORMATION OF THE TANGS AND DAMAGE IN THE HEX RECESS WHEN TORQUE WAS APPLIED. THIS COMPLAINT IS DUE TO MISUSE AND IS THEREFORE INVALID.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A TFN LAG SCREW REMOVAL PROCEDURE. THE PATIENT WAS IMPLANTED WITH A TFN CONSTRUCT ON AN UNKNOWN DATE. THE PATIENT WAS RETURNED TO SURGERY FOR REMOVAL OF THE LAG SCREW DUE TO ARTHRITIS AT WHICH TIME THE PATIENT WAS REVISED TO A TOTAL HIP. WHILE THE LAG SCREW WAS BEING REMOVED, THE FLANGES ON THE INSERTER EXTRACTOR BECAME BENT, RENDERING THE DEVICE UNUSABLE. THE SURGEON USED ANOTHER INSERTER TO REMOVE THE LAG SCREW. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS REPORT #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR TROCH.FIX. NAIL SCREW INSERTER/EXTRACTOR HSB SYNTHES GMBH 3668116

    Patients

    Seq Age Sex Outcome Treatment
    1