BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-07468

    MDR report key: 3483344 · Received November 22, 2013

    Report

    Report Number
    2520274-2013-07468
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    November 2, 2013
    Report Date
    November 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. REPORT IS FOR AN UNKNOWN HELICAL BLADE, QUANTITY 1. (B)(4). PMA/510(K): CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED ON THE FOLLOWING RETURNED PRODUCTS: HELICAL BLADE INSERTER (PART# 357.372), A 130 DEGREE AIMING AIM FOR TROCHANTERIC FIXATION NAILS (PART# 357.366), HELICAL BLADE COUPLING SCREW (PART# 357.377) THESE INSTRUMENTS ARE CRITICAL COMPONENTS OF THE TI TROCHANTERIC FIXATION NAIL (TFN) SYSTEM INTENDED FOR THE INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE AIMING ARM IS USED FOR ALIGNMENT AND THE HELICAL BLADE INSERTER AND HELICAL BLADE COUPLING SCREW ARE SPECIFICALLY FOR INSERTION OF THE HELICAL BLADE. THE RETURNED 130 DEGREE AIMING AIM, (PART# 357.366 LOT # 1901865, MANUFACTURED 8/2008) WAS RECEIVED SHOWING SIGNS OF WEAR CONSISTENT WITH THE EXPECTED CONDITION FROM HEAVY USE. THE RETURNED HELICAL BLADE COUPLING SCREW (PART# 357.377, LOT # 6454141, MANUFACTURED 12/2010) WAS RECEIVED SHOWING SIGNS OF WEAR AND HAMMER MARKS ON THE PROXIMAL END. THIS IS CONSISTENT WITH THE EXPECTED CONDITION FROM HEAVY USE OVER 3 YEARS AS THE PROXIMAL END IS DESIGNED FOR WITHSTANDING LIGHT HAMMERING. THE RETURNED HELICAL BLADE INSERTER(PART# 357.372 LOT # 6439297, MANUFACTURED 07/2010) WAS RECEIVED SHOWING SIGNIFICANT DEFORMATION AND WEAR. THE HANDLE WAS DENTED WITH NUMEROUS DEEP HAMMER MARKS AND MANY SMALLER MARKS ALONG THE ENTIRE LENGTH. THE ALIGNMENT INDICATOR SHOWS HAMMER MARKS ON ALL SURFACES AND IS MISSING THE LOCKING SHAFT, THUS ALLOWING IT TO ROTATE FREELY. THE ALIGNMENT INDICATOR IS ALSO NO LONGER ROUND WHERE THE MISSING LOCKING SHAFT WOULD BE INSERTED. THE THREE GUIDE PINS ON THE DISTAL END EACH SHOW A WORN FLAT ON THE ROUND. THIS DEFORMATION IS CONSISTENT WITH ERRANT HAMMERING AND FORCEFUL MISALIGNMENT. THE HELICAL BLADE INSERTER IS NOT DESIGNED TO BE HAMMERED OR TO BE USED IN IMPLANT REMOVAL BUT THE DEEP HAMMER DENTS IN BOTH THE DIRECTION OF INSERTION AND REMOVAL SHOW SIGNS OF MISALIGNMENT, MIS-STRUCK HAMMER BLOWS, AND THAT HAMMERING WAS USED IN THE REMOVAL OF THE HELICAL BLADE. THE FLATS ON THE GUIDE PINS SHOW SIGNS THAT FORCEFUL MISALIGNMENT OCCURRED. THERE IS ONLY ONE CORRECT ALIGNMENT OF THE HELICAL BLADE INSERTER INTO THE BLADE GUIDE SLEEVE SUCH THAT THE GUIDE PINS WILL MATE WITH THE GROOVES ON THE BLADE GUIDE SLEEVE. THE FREE ROTATION OF THE ALIGNMENT INDICATOR ADDS THE ADDITIONAL RISK OF MISALIGNMENT. THE CORRESPONDING TFN, INSERTION HANDLE, BLADE GUIDE SLEEVE, BUTTRESS/COMPRESSION NUT, AND HELICAL BLADE WERE NOT RECEIVED SO THE COMPLAINT CANNOT BE REPLICATED. THUS, THE RETURNED COMPONENTS WERE ASSEMBLED TO A SAMPLE TFN (PART # 456.477, LOT #4328328), INSERTION HANDLE (PART # 357.411, LOT # 4522808), BLADE GUIDE SLEEVE (PART # 357.369, LOT #4545108), BUTTRESS/COMPRESSION NUT (PART # 357.371, LOT # 4546699), AND HELICAL BLADE (PART # 456.305) TO EVALUATE THE INTERFACE OF THE COMPONENTS IN THE RECOMMENDED CONSTRUCT. THE COMPONENTS ASSEMBLED CORRECTLY; THERE WAS NO ISSUE IN INSERTING THE HELICAL BLADE AND THE ALIGNMENT WAS AS INTENDED. THE FLATS ON THE HELICAL BLADE INSERTER ADDED MARGINAL RESISTANT BUT THE CONSTRUCT DID NOT FAIL TO PROPERLY ALIGN THE HELICAL BLADE. REPEATED MISALIGNMENT OF THE BLADE INSERTER AND CONSEQUENTIAL HAMMERING AND MIS-STRUCK HAMMER BLOWS APPEAR TO HAVE CAUSED THIS COMPLAINT CONDITION. THEREFORE, IT IS LIKELY THAT THE METHOD OF USE AND/OR THE USE OF WORN COMPONENTS RATHER THAN A DESIGN DEFICIENCY HAS LED TO THIS COMPLAINT. A REVIEW OF THE CURRENT DRAWINGS AND THE CORRESPONDING DCOS WAS PERFORMED. THE INSTRUMENTS WERE ALL FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    DURING A TROCHANTERIC FIXATION NAIL SYSTEM (TFN) PROCEDURE ON (B)(6) 2013, THE SURGEON HAD DIFFICULTY INSERTING THE HELICAL BLADE THROUGH THE NAIL. THE PROCEDURE WAS COMPLETED BUT REDUCTION WAS NOT SATISFACTORY. THE PATIENT WAS CLOSED AND SENT TO A LEVEL 1 FACILITY FOR FURTHER TREATMENT. THE SURGEON INDICATED THE INSERTER WAS DAMAGED AND HE HAD PROBLEMS WITH THE COUPLING SCREW. THE PATIENT WAS REVISED AT THE LEVEL 1 FACILITY ON (B)(6) 2013. THE TFN IMPLANTS WERE REMOVED WITHOUT INCIDENT AND PATIENT WAS REVISED TO A LONGER TFN, NEW HELICAL BLADE AND SCREWS. THE REVISION SURGEON FELT THE IMPLANTATION PROBLEMS MAY HAVE INVOLVED THE ANGLE AT WHICH THE HELICAL BLADE WAS INSERTED AND MAY HAVE BEEN FURTHER COMPLICATED BY THE NATURE OF THE FRACTURE WHICH MAY HAVE INTERFERED WITH THE INSERTION. INSTRUMENT PROBLEMS WERE ALSO A POSSIBILITY. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. THIS REPORT IS 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608824 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention