BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 4199061 · Received October 24, 2014

    Report

    Report Number
    2530088-2014-10333
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 27, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE RETURNED HELICAL BLADE COUPLING SCREW (LOT 5241174) WAS MANUFACTURED ON SEPTEMBER, 2006 AND IS 8 YEARS OLD. THE HELICAL BLADE COUPLING SCREW WAS RECEIVED WITH THE KNURLED KNOB SEPARATED AT THE PROXIMAL END TUBE UNION . PER THE TECHNIQUE GUIDE, THE HELICAL BLADE COUPLING SCREW IS PART OF TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM AND IT IS USED IN THE INSERTION OF THE HELICAL BLADE DURING TFN PROCEDURE. SEPARATED SURFACES ARE HOMOGENOUS WITH CLEAR MATERIAL SEPARATION, WELDMENT REMAINS INTACT. THE KNOB SHOWS EVIDENCE OF HEX DRIVE WEAR AND SUBSTANTIAL HAMMER MARKS ON THE PROXIMAL SIDE OF THE KNOB CONSISTENT WITH HEAVY USE. THE THREADS ON THE DISTAL END OF THE TUBE ARE PARTIALLY FLATTENED. THE TUBE LENGTH SHOWS CONSIDERABLE DISCOLORATION, ROLL MARKS, AND SCRATCHES CONSISTENT WITH HEAVY USE. A REVIEW OF THE DESIGN DRAWING INDICATES THAT THE RETURNED PART WAS MANUFACTURED TO THE RELEVANT DRAWING SINCE THEN THERE WAS ONE DESIGN CHANGE TO THE DRAWING THAT DID NOT AFFECT THE INTENDED USE OF THE DEVICE. THE METHOD OF USE RATHER THAN A DESIGN DEFICIENCY HAS LED TO THIS COMPLAINT. THE CAUSE OF THIS COMPLAINT IS DUE TO THE SURGEON HAMMERING THE HEAD OFF-ANGLE OR THE SURGEON HAMMERING THE HEAD WHEN THE SCREW IS NOT FULLY TIGHTENED CAUSING THE KNURLED KNOB TO BREAK OFF. THEREFORE, THIS COMPLAINT IS CONFIRMED HOWEVER, THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. EVENT DATE: INITIALLY REPORTED AS (B)(6) 2014; SHOULD HAVE BEEN (B)(6) 2014. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6) REPORTED THE TIP OF THE COUPLING SCREW BROKE OFF DURING A TROCHANTERIC FIXATION PROCEDURE. THE SURGERY WAS DELAYED BY FIVE MINUTES; THE PROCEDURE WAS COMPLETED USING A SIMILAR/LIKE DEVICE FROM ANOTHER SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678117 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5241174

    Patients

    Seq Age Sex Outcome Treatment
    1