BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 115MM STERILE

    MDR report key: 6352893 · Received February 23, 2017

    Report

    Report Number
    2520274-2017-10584
    Event Type
    Injury
    Date Received
    February 23, 2017
    Report Date
    January 31, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN HELICAL BLADE. PART#, LOT# AND UDI # IS NOT AVAILABLE. EXACT DATE OF IMPLANT PROCEDURE IS UNKNOWN. DEVICE WAS IMPLANTED APPROXIMATELY EIGHTEEN (18) MONTHS PRIOR TO THE AWARENESS DATE OF (B)(6) 2017. REVISION SURGERY WAS PLANNED FOR (B)(6) 2017. DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERAPY DATE OF CONCOMITANT DEVICES IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN HELICAL BLADE. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 7953069. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 30 MARCH 2015. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 115MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    IT IS REPORTED PATIENT WAS IMPLANTED WITH A LEFT FEMORAL NAIL, HELICAL BLADE, AND LOCKING SCREW APPROXIMATELY EIGHTEEN (18) MONTHS PRIOR TO THE AWARENESS DATE OF (B)(6) 2017. ON (B)(6) 2017, SURGEON SENT A TEXT MESSAGE CONTAINING AN X-RAY TAKEN ON (B)(6) 2017 SHOWING A HELICAL BLADE THAT HAD MIGRATED MEDIALLY FROM THE NAIL. PATIENT WILL BE RETURNED TO SURGERY ON (B)(6) 2017. AT THIS TIME, IT IS UNKNOWN WHAT WILL BE DONE DURING THE REVISION PROCEDURE. CONCOMITANT DEVICES REPORTED: TROCHANTERIC FEMORAL NAIL (QUANTITY 1), LOCKING SCREW (QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE ALL HARDWARE WAS REMOVED. DURING THE REVISION, THE EXTRACTOR WAS ATTACHED TO THE NAIL AND THE LOCKING MECHANISM WAS BACKED OFF. THE HELICAL BLADE AND DISTAL 5.0MM LOCKING SCREW WERE REMOVED. SURGEON THEN MANUALLY PULLED ON THE EXTRACTOR AND ONLY THE PROXIMAL PORTION OF THE NAIL WAS EXTRACTED, LEAVING THE DISTAL PORTION OF THE HELICAL BLADE IN THE FEMORAL CANAL. THE NAIL WAS BROKEN FROM THE HELICAL BLADE HOLE DOWN. THE HELICAL BLADE & SCREW COUPLING SCREW WAS THEN INSERTED DOWN INTO THE FEMORAL SHAFT AND THREADED INTO THE DISTAL PORTION OF THE NAIL. ONCE THREADED, SURGEON WAS ABLE TO GENTLY BACK SLAP THE COUPLING SCREW AND REMOVE THE REMAINDER OF THE NAIL. WHEN ALL HARDWARE WAS REMOVED, PATIENT WAS REVISED TO A HEMIARTHROPLASTY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THIS COMPLAINT ADDRESSES THE REVISION DUE TO HELICAL BLADE MIGRATION. BROKEN NAIL THAT OCCURRED DURING THIS PROCEDURE IS ADDRESSED IN (B)(4). NO DEVICES WILL BE RETURNED, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136674 TFNA HELICAL BLADE 115MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 7953069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ONE (1) UNKNOWN LOCKING SCREW| ONE (1) UNKNOWN TROCHANTERIC FEMORAL NAIL