BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM

    MDR report key: 3921200 · Received July 9, 2014

    Report

    Report Number
    1719045-2014-10301
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    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.

    Additional Manufacturer Narrative · 1

    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

    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.

    Additional Manufacturer Narrative · 1

    THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE IMPLANTS ARE COMPONENTS OF THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM. THIS INFORMATION IS PROVIDED PER TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM TECHNIQUE GUIDE J3900-I. THE RETURNED LOCKING SCREW, LOT # 7410713, WAS RECEIVED IN GOOD CONDITION WITH WEAR TO THE THREADS AND HEX DRIVE. THIS CONDITION IS CONSISTENT WITH THE EXPECTED WEAR FROM USE. THE RETURNED HELICAL BLADE, LOT # 7565713, WAS RECEIVED PARTIALLY EXTRACTED FROM THE NAIL AND STUCK IN ITS CURRENT POSITION. THERE IS A SIGNIFICANT CUT INTO THE BLADE NEAR THE NAIL REDUCING THE DIAMETER BY APPROXIMATELY 75% AND THE DEVICE SHOWS SCRAPE AND WEAR MARKS. THE RETURNED NAIL, LOT # 7523635 WAS RECEIVED WITH SEVERE DAMAGE TO THE INSIDE OF THE CANNULATION NEAR THE HELICAL BLADE HOLE. THERE ARE SCRAPE AND WEAR MARKS OVER THE DEVICE THAT WERE LIKELY CAUSED WHEN THE HELICAL BLADE WAS CUT. THE LOCKING TAB PORTION OF THE LOCK PRONG IS BENT AROUND THE HELICAL BLADE INSIDE THE NAIL AND THE OTHER HALF OF THE LOCK PRONG IS MISSING. THE LOCKING DRIVE WAS RECEIVED WORN AND SEPARATED FROM THE NAIL. THE DISTAL END OF THE NAIL IS IN GOOD CONDITION WITH SIGNS OF WEAR CONSISTENT WITH THE EXPECTED WEAR FROM USE. THE COMPLAINT CONDITION CANNOT BE REPLICATED BECAUSE THE HELICAL BLADE AND NAIL ARE STUCK TOGETHER AND ALREADY SEVERELY DAMAGED. BASED ON THE RETURNED CONDITION OF THE LOCKING TAB, THE JAMMED CONDITION OCCURRED BECAUSE THE LOCK TAB PORTION OF THE LOCK PRONG IS BENT AROUND THE HELICAL BLADE AND BROKEN OFF FROM THE REST OF THE LOCKING PRONG. THIS CONDITION OF THE TAB IS CONSISTENT WITH THE RESULT OF FORCEFUL ATTEMPTED REMOVAL WITH THE LOCKING TAB STILL ENGAGED. THE HELICAL BLADE, NAIL, AND LOCKING SCREW WERE ALL MANUFACTURED AFTER THE RELEASE OF THE CURRENT DRAWING REVISION. THEREFORE, A REVIEW OF THE CURRENT EDITION OF THE DESIGN DRAWINGS (456_301 REV. G, 456_314 REV. E, AND 458_926 REV. K) WAS PERFORMED. THE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE. THE REPORTED ISSUE OF HELICAL BLADE MIGRATION WAS LIKELY IMPACTED BY THE PATIENT¿S AGE, BONE QUALITY, AND PROPER SELECTION OF IMPLANT LENGTH AND ANGLE. THERE IS NO INDICATION THAT THE DEVICE DESIGN CONTRIBUTED TO THIS COMPLAINT CONDITION OF IMPLANT MIGRATION AND THE BROKEN NAIL. THEREFORE, THIS COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY. IN CONCLUSION, THE BROKEN NAIL AND JAMMED CONDITION OF THE HELICAL BLADE IS CONFIRMED. SINCE X-RAYS COULD NOT BE OBTAINED, THE CONDITION OF IMPLANT MIGRATION IS UNCONFIRMED. THE COMPLAINT CONDITION WAS THE RESULT OF THE METHOD OF USE AND THE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE. THE RISK ANALYSIS ADEQUATELY ADDRESSES THE COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT PATIENT HAD A TROCHANTERIC FIXATION NAIL (TFN) AND HELICAL BLADE IMPLANTED ON (B)(6) 2014 FOR AN INTERTROCHANTERIC HIP FRACTURE. ON (B)(6) 2014 THE TFN AND HELICAL BLADE WERE REMOVED DUE TO HELICAL BLADE CUT OUT OF THE HEAD OF THE TFN. DURING THE REMOVAL, ONLY THE THREADED PORTION OF THE LOCKING TAB CAME OUT. IT WAS NOT POSSIBLE TO REMOVE THE REST OF THE LOCKING TAB, THE SURGEON HAD TO SPLIT THE TROCHANTER IN ORDER TO SUCCESSFULLY REMOVE THE TFN AND HELICAL BLADE. THE EVENT RESULTED IN A 45 MINUTE DELAY; THE TFN AND HELICAL BLADE WERE SUCCESSFULLY REMOVED. THE PATIENT WAS REVISED TO A HIP REPLACEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400349 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7523635

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention